INNOVATIONS IN TREATMENT FOR DRUG ABUSE: Solutions to a Public Health Problem

Transcription

1 Annu. Rev. Public Health : Copyright c 2001 by Annual Reviews. All rights reserved INNOVATIONS IN TREATMENT FOR DRUG ABUSE: Solutions to a Public Health Problem Jody L Sindelar 1 and David A Fiellin 2 1 Yale University School of Public Health, New Haven, Connecticut 06520; jody.sindelar@yale.edu 2 Yale University School of Medicine, New Haven, Connecticut 06520; David.Fiellen@yale.edu Key Words treatment of illicit drug use Abstract Illicit drug use is an important public health problem with broad social costs. The low effectiveness of prevention efforts leaves treatment of drug dependence as one of the most powerful means of fighting illicit drug use. Treatment reduces drug use and crime and increases individuals functioning. However, programs that treat drug dependence have high dropout rates and low completion rates. In addition, some individuals continue to use drugs while in treatment, and relapse is common. Furthermore, only a fraction of those who need treatment receive it. Recently, there have been important innovations that reduce barriers and increase effectiveness of treatment. These innovations include new pharmacological agents, novel counseling strategies, promising ways to motivate, and treatment in new settings. This paper describes standard treatments and recent innovations designed to increase (a) effectiveness of treatment, (b) motivation to seek care, (c) access, (d) retention, and (e) cost-effectiveness. We provide criteria on how these innovations should be evaluated in order to determine which should be adopted, funded, and transferred to existing and future treatment programs. INTRODUCTION Use of illicit drugs and, in particular, dependence on drugs are important public health problems. Drug use harms society by reducing user s physical and mental health and productivity, by reducing family and social functioning and by increasing crime. Illicit drug use contributes to the spread of contagious diseases, including HIV/AIDS, hepatitis B and C, and tuberculosis. Furthermore, illicit drug use contributes to the disintegration of families and of inner city communities and has resulted in a huge growth in the prison population, especially of African-American males (83). Popular prevention programs such as DARE are ineffective (61). High rates of incarceration based on drug-related crimes have not had a major impact on drug use (94, 95). Thus, treatment may be the most powerful means of fighting /01/ $

2 250 SINDELAR FIELLIN the ills of illicit drugs usage. Treatment reduces costs to society and, in terms of societal costs averted, largely in savings from the criminal justice system, even pays for itself (34). Despite this, only a small percentage of those who use illicit drugs receive treatment (46). This treatment gap occurs because of low motivation to seek treatment and limited funding. Limited funding may occur both because of negative attitudes about inner city illicit drug users and because of skepticism about the effectiveness of treatment as a cure. Although drug abuse treatment can reduce drug use and crime and increase social functioning (5), it is not a cure. In addition, drug treatment programs have been plagued by poor retention and high relapse. This paper discusses recent advances in pharmacotherapy and psychosocial treatments that are designed to increase motivation to seek treatment, access to treatment, retention of those being treated, and effectiveness of treatment programs. We first discuss the three types of standard care: methadone maintenance, outpatient counseling-based treatment, and therapeutic communities. We then discuss innovations in (a) pharmacotherapy (buprenorphine), (b) treatment settings (methadone in physicians offices and treatment in prison), (c) new maintenance therapies for treatment refractory heroin users (heroin maintenance), (d) promising incentives to seek care (treatment as an alternative to prison), (e) providing greater incentives to reduce illicit drug use through novel counseling methods (contingency management), and ( f ) targeting treatment to those who impose the greatest costs on society (the incarcerated). BACKGROUND Use of illicit drugs is of critical concern to citizens, parents, and policy makers. It is a major public health concern. Roughly 56% of the US population reports that drug abuse is one of the most serious domestic problems (94). Approximately 6% of the US population older than 12 years old, roughly 14 million people, self-reported use of illicit drugs in a single month in 1997 (94). In 1996, about 9 million people, over half of them opioid dependent, were estimated to need treatment for drug use. Of these, only 37% received treatment (80), mostly for cocaine (38%), heroin (25%), and marijuana (19%) use (75). Of 800,000 heroin-dependent individuals, only 180,000 were able to access treatment in narcotic treatment programs with medications such as methadone (80). This treatment gap likely occurs for multiple reasons, including lack of geographic access to appropriate care, cost of care, lack of insurance, lack of desire for treatment, skepticism about the effectiveness of treatment, and stigma attached to treatment. Treatment could reduce costs to society and enhance the overall functioning of individuals and families. Substance abuse increases morbidity and mortality, reduces overall mental and physical health, engenders use of medical resources, leads to missed opportunities in life, disrupts neighborhoods, and reduces productivity.

3 INNOVATIVE DRUG ABUSE TREATMENTS 251 Even those who are not drug users are affected. Externalities include drug-related crimes, spread of contagious diseases, and the risk of adolescents use of drugs (40, 46). Illicit drug use is responsible for over 25,000 deaths annually. In 1992, total costs, including health care expenditures, lost productivity, crime-associated costs, and other factors, were estimated to be 97 billion dollars (39). The category lost productivity, the largest at 69 billion dollars, includes the value of time lost due to premature death, institutionalization, incarceration, and victimization by crime. Crime-related cost is the second biggest cost category, at almost 18 billion dollars. Health care expenses constitute the third major category, which is estimated to cost society about 10 billion dollars (39). There are also many hard-to-quantify costs that do not get measured in costof-illness studies. These include reduced self-esteem of drug users, disruption of families, poor parenting, abandoned children, fear in the general population of drugs and drug-related crime, and disrupted neighborhoods. There are a few equally difficult to measure potential benefits of illicit drug use, e.g. brief euphoria and relief from physical or psychic pain. The important negative externalities make paying for substance abuse treatment an important role for the government. The federal, state, and local governments pay for most of drug treatment. In 1998, the Uniform Facility Data Set (111) reported that 70% of all treatment at substance abuse facilities was paid for by the government. Even though the government is by far the largest overall payer, Medicare and Medicaid offered relatively little in treatment coverage. Medicare paid only 3% and Medicaid paid just over 16%. A large portion of the treatments is funded by federal block grants to states; states then allocate these funds to local levels, where the care is provided. Roughly 11% comes from patient fees, and private health insurance pays for only 15% (111). STANDARD TREATMENT MODALITIES We describe three drug treatment modalities that in the United States have become key: methadone maintenance; outpatient counseling-based care, which is the most common; and therapeutic communities. We do not consider detoxification or inpatient care. Detoxification is not a stand-alone treatment, and because of funding cuts, managed care, and studies that suggest that it is not as cost-effective as outpatient care, inpatient care has become much less prevalent than in the past (6). Methadone Maintenance and Other Pharmacotherapies Methadone Maintenance The publication in the late 1960s of a set of influential articles by Dole & Nyswander (23, 24) brought about an expansion in methadone maintenance programs. Methadone, a synthetic narcotic analgesic, is an effective treatment for heroin and other opiates (5). It prevents opioid withdrawal (e.g. muscle cramping, abdominal pain, irritability, and agitation) and blocks the

4 252 SINDELAR FIELLIN high of heroin. Used on a maintenance basis, methadone produces neither euphoria nor sedation, allowing the individual to proceed to live a productive life. Patients typically obtain their oral medication at a clinic on a daily basis; successful patients may earn the right to obtain take-home dosages. Methadone maintenance has been one of the most studied modalities of treatment for drug dependence (20, 21). Evaluations repeatedly demonstrate that despite difficulties with retention and relapse, methadone maintenance results in reduction in crime and drug use for those in treatment (5, 17, 18, 78). Studies show that higher doses of methadone (e.g mg) are more effective in reducing illicit drug use than are lower dosages (e.g mg) (106, 108). Higher levels of adjuvant psychosocial counseling also produce improved treatment retention and decreased illicit drug use (66, 68). The use of prescribed opiates to treat opiate dependence has engendered some controversy. In response, federal and state governments have strictly regulated methadone maintenance to ensure quality care and to limit the diversion of methadone to non-medical uses of opioid agonist medications (5, 18, 91, 112). Current federal regulations result from legislative efforts, such as the Harrison Act of 1914 and the Narcotic Addict Treatment Act of These regulations detail licensing requirements and specify staffing obligations, frequency of program contact, duration of treatment, frequency of urine toxicology testing, and frequency of counseling. In the United States, methadone maintenance is delivered through approximately 900 narcotic treatment programs. These dedicated narcotic clinics can reduce the per-treatment administrative costs of providing methadone and adhering to the regulations. They have developed primarily in inner city locations, making it difficult, if not impossible, for geographically distant users to benefit from them. Clinics are typically supported by government block grants and primarily serve the indigent. Some clinics have substantial waiting lists, but the number of slots cannot be quickly increased to respond to the need in part because of federal and state regulations. In some states, even an existing facility may need approval of a certificate of need to expand. Other Pharmacotherapies LAAM. Levo-alpha acetylmethadol (LAAM) is a derivative of methadone that was approved by the US Food and Drug Administration for maintenance treatment in Because it is a long-acting medication, LAAM can be used on a thriceweekly schedule from the outset of treatment. The relatively fewer clinic visits offer the possibility of decreased clinic costs compared with methadone, which must be provided on a daily basis for the first 2 years of treatment. However, new regulatory processes, clinic acceptance, and insurance reimbursement have restricted the use of LAAM (90), despite its effectiveness, which is similar to methadone (57, 58).

5 INNOVATIVE DRUG ABUSE TREATMENTS 253 Naltrexone. Naltrexone is a fast-acting (good oral bioavailability), long-acting opioid antagonist that is safe and effective for treatment of opioid dependence. Naltrexone blocks the euphoric effect of opioids. The major disadvantage of naltrexone is that individuals must be off opioids at least a week prior to use. Opioids such as heroin in an individual s system precipitate an immediate withdrawal syndrome, such as nausea, sweating, and muscle aches with the use of naltrexone. Thus, naltrexone, which has demonstrated short-term (4 weeks) retention rates of less than 40%, is appropriate for only highly motivated individuals (36). Most heroin addicts on methadone still take some heroin and therefore are not candidates for naltrexone. Furthermore, in routine clinical care, naltrexone maintenance results in large dropout rates (36). Thus, despite the fact that naltrexone has desirable pharmacological properties (71), it has not gained widespread acceptance. A new depot version of naltrexone is being developed that will have a 30-day impact from a single dosage (16). This development may lead to more widespread usage, possibly in the criminal justice system. Issues to Address in Pharmacotherapies. Despite the clinical effectiveness of methadone and LAAM, many heroin users still do not get treatment and others suffer from low retention in programs and from high relapse (5, 79). There are many potential reasons for the limited use, e.g. stigma, location, funding, and motivation. Several major national reports have suggested that a restructuring of the regulatory process may help to expand access (74, 82, 91). Problems may also be addressed by new medications to increase effectiveness and utilization. Outpatient Counseling-Based Treatment Description Outpatient counseling programs, the most common method of treating drug abuse and dependence, range from professional psychotherapy to peer counseling and 12-step meetings. In fact, counseling strategies (e.g. 12-step facilitation) that are designed to be supplemented by attendance at such self-help groups as Narcotics Anonymous and Alcoholics Anonymous are among the more prevalent. Counseling can occur in individual, family, or group sessions. These programs are heterogeneous in length of stay, philosophy, training of staff, degree of professionalism, funding, clientele, and other characteristics. Programs may vary from a few sessions to many weeks. Even more variation is introduced by patient adherence to scheduled sessions and retention. Thus it can be hard to generalize about the effectiveness of the programs. Some programs are abstinence based and their philosophy rejects the use of any pharmacological treatments. Other programs are primarily counseling based but supplement with pharmacotherapy as needed. Counseling programs can be based in psychology, social work, the 12-step creed, or other approaches. The 12-step or Minnesota Model (Hazelden program) is a well-known and commonly used abstinence-based program. Treatment begins with detoxification and proceeds

6 254 SINDELAR FIELLIN through several of the 12 steps. Attendance can range from one to two sessions per week for 7 12 weeks to 90 meetings in 90 days. There has been some interest in matching treatments to patient needs to increase the effectiveness of treatment. The results have been mixed (21, 67, 70, 88). In the field of alcohol research, Project MATCH tested the hypothesis that matching patients according to certain characteristics, such as gender, motivation, psychiatric disorder, and severity, to specific treatment modalities, such as cognitive behavioral therapy, motivational enhancement therapy, or 12-step facilitation, can lead to improved outcomes. The results of this large-scale clinical trial demonstrated similar patient outcomes with all three treatment modalities irrespective of baseline clinical variables, indicating that treatment matching may not be very productive (88). One advantage of counseling programs is that they can be suitable for treating a variety of drugs individually or jointly. Statistics show that most patients in outpatient drug counseling programs are not opiate users. They more typically are abusers who are not dependent nor are involved with the criminal justice system (33). Thus, this population comprises a different group of drug abuser than those in methadone maintenance or other treatment modalities. Success rates across treatment modalities should be interpreted with these severity differences in mind. Issues to Address in Outpatient Counseling Effectiveness of treatment is thought to be a function of retention in treatment. However, many patients drop out prior to the prescribed length of stay in treatment. Thus, both retention and effectiveness are problems with outpatient treatment. New methods are being developed to motivate individuals to seek and remain in care. Therapeutic Community Description Therapeutic communities (TC) are often long-term residential programs that emphasize socialization, lifestyle, and behavioral change. TCs do not use pharmacologic treatment. Typically, those in a TC have tried other treatment modalities and have failed. The TC is an intensive, highly structured residential, communal treatment that operates according to a somewhat distinct, but not codified, philosophy. The philosophy is aimed toward self-help and a structured reward system and has a reality-based approach. The person is considered the problem, not the drug per se. Those in TCs usually have major personality problems, have little education, have poor interpersonal skills, are socially maladjusted, and have little in the way of employment experience or marketable skills. Group meetings, psychological counseling, and reality-oriented group sessions are used to reduce negative thinking and promote prosocial behavior (22). A reward and punishment system also promotes responsibility and prosocial behavior. Patients in recovery initiated the first TCs and currently the majority of the staff are graduates of a TC. Most programs supplement this staff with professionals, such as psychologists.

7 INNOVATIVE DRUG ABUSE TREATMENTS 255 Those in treatment live in a communal, largely self-sufficient setting and must follow prescribed and proscribed rules of behavior with sanctions for transgressions. Goals of treatment are not only the reduction of drug use but also the adoption of more socially acceptable norms and behaviors. Anticipated lengths of stay can range from 4 months to 2 years, with gradual reentry into regular life. However, patients frequently drop out prior to a year and relapse is high. One study of multiple facilities indicated that retention at 3 months ranged from 21% to 65%, with a median length of stay of 3 months (46). Effectiveness increases with length of stay, as is typical of most treatment modalities. Drug use in TCs is reduced for those who stay in treatment the recommended length of stay, e.g. a reduction in weekly heroin use from 17% at baseline to 6% at 1-year follow-up (46). However, many of the studies of effectiveness have been flawed by the fact that they compared those who graduate (e.g. stay in the program for say a year) with those who drop out (46). Issues to Address with TCs Participation in a TC can be difficult. The dropout rate is high because it is a tough, long program. Furthermore, relatively few of those appropriate for this type of care are motivated to enter. Thus, although those who complete the program have demonstrated success, few enter and many dropout. One relatively new development is the growth of TCs in prison. The provision of TCs and other types of treatment in prison is discussed below. INNOVATIONS We discuss some the recent innovations in treatment that are designed to increase effectiveness, including new pharmacological (buprenorphine and cocaine vaccine) agents, psychosocial approaches (contingency management), and heroin maintenance for refractory individuals. In addition, we discuss new settings, such as methadone in a primary care physician s office and treatment in prison, that increase access to care. Other innovations, such as treatment in lieu of prison, may increase motivation to seek care. Buprenorphine Maintenance Buprenorphine is a pharmacotherapy for the treatment of opioid dependence that is currently pending approval by the Food and Drug Administration. Compared with methadone, LAAM, and naltrexone, it has several unique properties. It has shown an effectiveness similar to (9, 59, 60, 107), more effective than (51), or slightly less effective than (54) methadone in treating those dependent on heroin. Like methadone, it has opioid agonist properties, which means it will block the high of heroin, thus reducing the desire to take it. Unlike methadone, however, buprenorphine is a partial (not complete) agonist and has a relatively low ceiling

8 256 SINDELAR FIELLIN effect, which means that increasing dosages do not increase euphoria and do not cause respiratory depression (52). This reduces the potential for overdose with buprenorphine. Buprenorphine is taken orally in a sublingual tablet. In the United States, it is being combined with naloxone in a single tablet so that if individuals try to dissolve the tablet and inject it, they will precipitate opioid withdrawal. Thus, there is less of a risk of diversion of buprenorphine/naloxone for abuse or sale. Another advantage of buprenorphine over methadone is its longer duration of action. This property allows patients to come to a clinic less frequently, perhaps three times per week, which saves both patients time (e.g. less travel and wait time) and program expenses. A key potential advantage of buprenorphine over methadone is the possibility of more-lenient federal and state regulations compared with methadone. The morelenient regulations for the combination tablet would result from the reduced likelihood of diversion and potential for overdose. The increased safety makes it likely that the combination medication will be approved as a controlled substance without requiring special Drug Enforcement Agency registration. Therefore, buprenorphine/naloxone could be available from physician offices, and providers would not have the licensing, staffing, and other restrictions required for dispensing methadone. More-lenient regulation (including provision in a primary care setting) combined with less frequent administration could greatly increase access. One study has already indicated that buprenorphine is cost-effective in reducing the spread of HIV (115). Buprenorphine has gained relatively widespread use in France to treat opioid dependence but is not yet available in the United States. Pricing has not been established but may be a determining factor in adoption of this treatment because the primary alternative medication, methadone, only costs about $0.50 $0.80 per dosage. Cocaine Vaccine Cocaine dependence has been difficult to treat. Prior attempts using dopamine agonist medication (e.g. bromocriptine and amantadine), antidepressants (e.g. desipramine), and serotonin reuptake inhibitors have not had the same success against cocaine as methadone has for heroin (5) or naltrexone for alcohol (83). Currently under development is a vaccine that would block the neurotoxicity and reinforcing properties of cocaine. The fundamental principle is the use of a vaccine to create antibodies against the cocaine molecule that would bind cocaine in the bloodstream. Early development has been promising, but there are concerns about the duration of efficacy and tolerance to repeated administration. Methadone Maintenance in Physician s Offices Methadone and LAAM are currently restricted to use in narcotic treatment programs. Provision of treatment in a physician s office would expand access and have

9 INNOVATIVE DRUG ABUSE TREATMENTS 257 appeal for some drug users who are not in treatment. Interest in using physicians offices as sites for coordinating methadone services (a concept often referred to as medical maintenance) has been growing because of the need to (a) expand access, (b) allocate the counseling resources of traditional drug treatment programs to those who need them most, (c) provide treatment in a setting with less stigma, and (d) limit contact of patients with those who are actively using drugs and, thus, may impede the success of treatment. Federal agencies, such as the Office of National Drug Policy (82), support expansion of physician office based treatment. A recent survey found that 30 state methadone authorities favored off-site physician linkages with methadone programs (84). Two published studies have reported successful medical maintenance programs in which stabilized (e.g. no evidence of active drug use for 1 or more years) methadone-maintained patients were transferred from care in narcotic treatment programs to medical maintenance settings (76, 77, 96). These programs have reported retention rates of 73% 85% for up to 3 years in some patients (77, 96). These favorable statistics suggest that medical maintenance programs may be used to expand access to methadone maintenance and reduce overcrowding in narcotic treatment programs. The provision of treatment in a primary care setting may draw new patients into treatment, expand access, and reduce overcrowding. Several important decisions must be made about treatment in a primary care setting. These include the following: Should only stabilized clients be treated in this setting; should stability in treatment be the sole criterion; should the physician s office have a base clinic; what is the acceptable level of professional training of providers; and how should such a relationship be organized? A key issue is whether medication dispensing should occur at the physician s office or at the pharmacy; the pharmacy offers longer hours but does not offer clinical backup. Insurance coverage and reimbursement rates will affect the success of these endeavors. Pilot medical maintenance programs are under way or have recently been completed in Connecticut, Maryland, New York, and Washington. Results from these studies may provide evidence to determine the effectiveness, the impact on access, and the cost-effectiveness of methadone maintenance in physicians offices. Heroin Maintenance Some heroin users, especially those with severe and refractory comorbid psychiatric disease, are unable to benefit from methadone maintenance (11). This led the Swiss government, in 1994, to conduct trials of heroin maintenance in cities throughout Switzerland. The goal was to determine whether heroin, morphine, or injectable methadone could reduce dependency, disease, and crime (110). The more than 1000 participants were those who had tried alternative treatment approaches on several different occasions without success. They were followed over the course of 2 years. The studies, carried out in outpatient clinics and one penal

10 258 SINDELAR FIELLIN institution, were either double blind, randomized, or based upon the clinician s discretion. The use of injectable heroin, rather than the other opiate substitutes, proved to be more effective in recruiting, retaining, and fostering compliance among the study participants. One trial demonstrated improvements in participants physical and mental health and social functioning and decreases in the use of illicit heroin, cocaine, homelessness, income from illegal and semi-legal activities, and criminal activity (110). For instance, the proportion of those with permanent, gainful employment increased from 14% to 32%, whereas the proportion of those unemployed fell from 44% to 20%. However, use of other substances, such as alcohol, cannabis, and benzodiazepines, remained relatively constant. Although this study was fairly large, it did not have a control group. Another study was smaller but had a control group (85). This study also found significant benefits to heroin maintenance. There were significant improvements in the experimental group relative to the control group in physical health, drug expenses, crime committed, and social functioning. There were, however, no gains in work, housing situation, and use of other drugs. There are several concerns regarding a heroin maintenance program. One is diversion of clinical supplies of heroin to an illicit market. Another is neighborhood disturbances due to clientele of the clinics and overdosing among participants due to their use of other drugs. Despite these concerns, analysis of the outpatient treatment programs suggests a net benefit of $30 per patient per day due largely to savings in criminal investigations, prison terms, and improvements in participants health (110). Netherlands has also begun similar initiatives, with a focus on addicts who have had several prior failed treatment attempts or have poor physical, mental, or social health status (110). Contingency Management Contingency management (CM) is a relatively new method of research-based treatments for substance abuse and dependence (10, 41 45, 93, 97, 104, 105). It has been used successfully to treat alcohol dependence, and it is particularly important, as it has been successful in treating dependence on cocaine whereas other methods have not. A central tenet of CM is abstinence from illicit drugs. CM uses an escalating reward system so that violations are punished both by denying the immediate reward and taking away the benefits of an escalated payment. CM has been implemented with several different types of rewards including monetary and vouchers. CM using vouchers as the reward would be conducted as follows. Cocainedependent individuals who are in treatment would typically receive drug abuse counseling. In addition, with CM, they are tested frequently for drug use. If their urine tests for drug use are clean, i.e. no evidence of drug use via the test, then they are given a reward, i.e. a voucher. Attention is paid to the prosocial nature of the voucher or reward, as there is a desire to steer clients toward socially

11 INNOVATIVE DRUG ABUSE TREATMENTS 259 beneficial activities (such as developing vocational skills, seeking employment, developing social support system of non drug users, etc) (86). The vouchers might be for bus tokens, food, or sporting goods. If the first test is negative (e.g. no drug use), then each subsequent drug-free test results in an escalating payment in vouchers. If the urine test detects drug use, the payment schedule is set back to zero. CM has been shown to be effective in reducing drug use during the treatment period, but there are several disadvantages. Payments in a voucher system can be relatively high. Between the monetary and the administrative costs (e.g. drug design and running the program), CM can become an expensive treatment method. Each client can earn up to $1000 and the average payment in some trials has been $600 (10, 41 43, 100). Another potential problem with CM is the politics of giving drug abusers payments for being clean, which is not palatable when the typical individual in the United States is drug free and receives no payment. The so-called fish bowl technique was designed to reduce the overall cost of CM (87). In the fish bowl technique, clients who test drug free are rewarded with the opportunity to select a piece of paper from the fish bowl. On most papers is written a prize. Although some have no prize, the majority have small prizes (e.g. bus tokens, food items), a smaller percentage has midrange prizes (e.g. electronics), and a few have larger prizes (e.g. hand held televisions). The treatment program can vary the percentages of no, small, and larger prizes, thereby affecting the overall cost. All prizes are to be compatible with a drug-free lifestyle. The clients make suggestions as to what prizes will motivate them and others. The pecuniary cost of running such a fish bowl can vary, as does the expected payment to drug-free clients. It is interesting that although one study suggested giving the same expected payments to clients, the escalating payment system was more effective in reducing drug use. CM has been shown to be effective in reducing drug use and increasing retention in treatment programs. A weakness of CM programs as they have been implemented is that rewards have been based on abstaining from only the drug that is the focus of the program. Thus, if the program is designed to reduce cocaine use, then a drug test revealing no use of cocaine is rewarded, even if other drugs have been used. Another concern is that when the program is completed and the reward structure disappears, individuals may revert to their old drug use patterns. CM has been studied in multiple clinical trials and found to be effective. However, it has yet to be used in a community setting. A current national multiple site research to practice effort funded by the National Institute on Drug Addiction is being initiated to determine the feasibility of use in a community setting. An advantage of CM is that it can be added to any type of treatment modality, e.g. counseling, TC, or methadone. Because it can increase retention, it may help the overall effectiveness of the initial modality in reducing drugs. The cost-effectiveness of adding CM to existing programs has not been evaluated. It may enhance effectiveness, but is the extra expense worth it?

12 260 SINDELAR FIELLIN Alternative Sanctions Used by the Criminal Justice System The increasing number of individuals arrested on drug-related charges has overcrowded existing prison facilities and prompted expenditures to build new prisons. The overcrowding and toll on government revenues has spurred a search for more effective and cost-effective alternatives. Alternative sanctions have been growing in type and number. Drug courts are a rapidly growing response to these problems. The first drug court started in 1989, and by 1996 there were 140 drug courts nationally (8). Drug courts provide an opportunity for those arrested primarily for drug possession to receive a court-supervised alternative to prison. Usually only nonviolent offenders are eligible because public safety is a key concern. The alternative usually involves attending an outpatient drug treatment program, weekly meetings with the court, and testing for drug use. Graduated sanctions are used for infractions of the protocol for behavior set by the courts, and the threat of incarceration as the ultimate sanction is real. These programs have been viewed as successful in reducing overcrowding of prisons, reducing government expenditure, and helping drug-dependent individuals seek treatment and avoid all the disruptions and negatives aspects of prison. Early analyses of drug courts suggest that they increase retention in treatment and substantially reduce drug use and crime during participation. There is some evidence that longer-term outcomes, such as reduced recidivism to crime, are also improved; however, extant studies have some design flaws and are suggestive but not conclusive (8). The motivation to seek treatment and remain in treatment is strong because it is court mandated, there is judicial follow-up on attendance, and the alternative is prison. Thus, drug courts represent one method of getting individuals who need treatment into appropriate programs and of keeping retention high. Retention in a treatment program has been found to increase the success of the individual. Previously, it was thought that individuals had to be self-motivated to seek treatment or it would not be as effective. Studies have shown that retention in a program is important even if the motivation to stay in care is compulsory and comes from the criminal justice system. In addition to drug courts, there are other alternative sanction programs. These programs tend to have the same fundamental approach of using the real threat of prison to motivate people to seek treatment for their drug problems and of monitoring the individual for compliance. For instance, there are coerced abstinence programs that allow early release of some drug-abusing, nonviolent prisoners to a probation program that frequently tests for drug abuse. Although treatment is not typically mandated in these programs, abstinence is and individuals may be more highly motivated to seek treatment to comply with their parole. Enrollment in a TC instead of prisons is used for selected, nonviolent, drug-addicted prisoners. Thus, the criminal justice system can be used to motivate drug-abusing felons to seek treatment. Furthermore, evidence supports the effectiveness of compulsory treatment. There are no formal economic studies of the alternative sanctions as opposed to incarceration, and thus statements about relative cost-effectiveness cannot

13 INNOVATIVE DRUG ABUSE TREATMENTS 261 be made. However, there is promise that this route will be both effective and costeffective. Treatment in Prison Treatment in state and federal prisons as well as discharge and post-discharge treatment planning are being increasingly viewed as an innovation in treatment. Treatment in prison has occurred in the past (56), but growth in the number of those in the prison population who have drug-addiction problems has sparked renewed interest in drug treatments in prisons. Most prison inmates are seriously involved with drugs and alcohol, even while in prison. About 80% of the 1.4 million people in jail or prison in 1996 (a) were involved with alcohol or drugs through possession of drugs, (b) were under the influence at the time of their crime, (c) stole to support a drug habit, or (d) had a history of drug and alcohol addiction (15). The increasing number of individuals in prison for drug possession has contributed to the large percentage of the prison population with a drug problem. Thus, the prison and jail populations may be helped by treatment for drug dependence and abuse. Treatment in prison may provide an effective and possibly cost-effective intervention (49, 63). Despite the apparent need for treatment, only 10% 20% of state and federal prisoners were receiving treatment while incarcerated (19). Historically, prison was seen as an opportunity for rehabilitation. More recently, incarceration has been viewed as a way to stop crime through captivity and deterrence. There are relatively few treatment programs in prison. The Rikers Island methadone maintenance program is one of the few prison methadone programs. It is offered only to those who will be in prison less than a year or to those who are soon to be released. There is a concern about security issues of storing methadone in the prison, but use of methadone has been thought to make the prisoners less disruptive and less likely to return to prison. Although Rikers has been viewed as a successful program, it is not being replicated in many prisons. The reasons may include the security risk and the desire to be tough on crime. Therapeutic communities have had a growing presence in prisons (50). Prison drug treatment programs have been found to reduce reincarceration, and preliminary evidence suggests that they are cost-effective (114). The effectiveness of these residential programs is enhanced by additional social services, such as aid in obtaining housing and assisting with establishing a treatment program on release from jail. Delaware is significantly expanding its offering of TCs in dedicated prison units and also expanding transitional programs to halfway houses. Several programs offering treatment in prison have been developed and evaluated (81). Breaking the Cycle is a research demonstration effort to test the effectiveness of a state-wide criminal justice intervention for drug-addicted offenders and involving judicial supervision, drug treatment, graduated sanctions, and drug testing. Stay n Out, started in 1977 by recovered addicts, is a prison-based therapeutic community that serves as national model for prison-based TC. KEEP is an

14 262 SINDELAR FIELLIN in-jail methadone maintenance program designed to foster transition to community methadone maintenance when released (62). Debates about treatment in prison remain. One debate is whether treatment should occur just prior to release or at the entrance to prison. Another is whether pharmacotherapies should be used or whether to rely on drug-free counseling and TCs, where there is less of a security risk due to medication being on site. ARE TREATMENTS EFFECTIVE? Some of these innovations in treatment will likely flourish by obtaining acceptance and substantial funding, whereas others may not. In part, their acceptance and funding will be based on findings from studies that evaluate the innovations effectiveness and cost-effectiveness. However, there is conflict even as to what criteria to use in evaluating outcomes. The extant literature and policy debates highlight some of the conflict. Standard substance abuse treatments have been considered to be very successful, and at the same time their effectiveness has been questioned. At least part of this conflict may be due to the fact that there are multiple outcomes from treatment and that these outcomes are valued differently, depending on one s perspective. On the negative side, there are many dropouts from programs and even those in the programs may continue to use drugs. Sometimes the specific drug being targeted gets eliminated or reduced, but other drugs may continue to be used, e.g. if a person is being treated and tested for heroin, he/she may still be using cocaine. Furthermore, ongoing but reduced drug use can occur. In addition, some individuals often reenter treatment and receive several rounds of treatment because substance abuse is a chronic and relapsing condition. Thus, one view of treatment is that the overall cure rate is low and that long-term abstinence is not typical. This is a viewpoint that plagues support for substance abuse treatment. However, by other perspectives, treatment can be seen as quite successful and on par in effectiveness with other chronic medical conditions. Treatment reduces drug use, reduces crime, enhances employment opportunities, and pays for itself in savings (34, 48, 101). Furthermore, if drug reduction not abstinence is the goal, then treatment can be viewed as successful. Harm reduction may be another criteria; if drugs are being used in safer ways, then the spread of AIDS, for example, may be mitigated. How outcomes are evaluated and the relative preference for different outcomes has implications for funding of treatment. For example, if reduced crime is the primary goal, then the recent increase in incarceration of drug users may be seen as an effective approach. If, on the other hand, disintegration of communities or rehabilitation of parents are top priorities, then this trend toward incarceration would be alarming. If cost-effective approaches to reducing crime are of paramount importance, then alternative sanctions specifying treatment as a condition of staying

15 INNOVATIVE DRUG ABUSE TREATMENTS 263 out of jail may be the top choice. If long-term abstinence is considered to be the only legitimate goal, then government funding for treatment could be jeopardized, as treatment may seem ineffective. If, on the other hand, reduced drug use, improvements in individual functioning, reduced crime, and savings are the primary goals, then treatment may be able to attract even greater funding. Society may be more concerned about drug use mainly as it affects externalities, such as crime, and government expenditures, such as welfare programs and criminal justice expenses. Some portion of society cares about the welfare of drug abusers. Many care about the many ways in which they and their families suffer. There is little survey data on what drug-dependent individuals seek in terms of outcomes from treatment. It is reasonable to suppose that those in treatment care about all the outcomes that directly pertain to themselves, e.g. reduced drug use, better family functioning, and better mental health (100). However, drug users may sometimes want to continue to use drugs but not suffer some of the associated harms and pains, such as withdrawal, e.g. they could be happy with relatively low levels of methadone that keep them from withdrawal while allowing them to enjoy the euphoria from other opioids. Assessments of current treatments and innovations must be based on appropriate and carefully developed and implemented criteria. Public policy decisions should be made based on the many social costs and benefits of treatments. Multiple outcomes and differing perspectives of the relevant importance of outcomes are important issues to contend with in evaluating the success of treatments and innovations (13, 71, 102). The answer to the question of to what extent is drug treatment effective depends on whose perspective is used and, thus, the factors considered and how they are measured. ARE TREATMENTS COST-BENEFICIAL AND COST-EFFECTIVE? There is increased interest in the degree to which drug abuse treatment is not only effective but cost-effective or cost-beneficial. The focus on economic evaluations reflects an interest in the question of whether society is getting its moneys worth from treatment. New treatment methods will likely have to meet the standard of cost-effectiveness analysis in order to gain acceptance. There are several forms of economic analysis of substance abuse treatment, each taking a different vantage point on outcomes. These are discussed below. Much of the focus of the discussion below is on outcomes; however, measurement of costs is also a critical area in which advances have been made (2, 22, 23, 26). Cost Offset Cost offset takes a fairly narrow range of outcomes: It includes only those that can readily be measured in pecuniary terms. It asks, does treatment pay for itself

16 264 SINDELAR FIELLIN CEA in terms of society s resources saved? These studies take society s perspective. They tend to focus on (a) government and other well-defined expenditures as costs and (b) relatively easy-to-quantify but sometimes difficult-to-attribute outcomes, e.g. reduced crime, medical expenses averted, and lives saved by drug treatment. The line of literature is sparse as applied to substance abuse, and the studies suffer from a variety of methodological problems (92). However, interpretation of findings may be an even greater problem. If treatments are found to pay for themselves, there still may be better uses of scarce funds. Furthermore, this does not necessarily mean that the government will actually save money, only that there are benefits that accrue to parts of society that offset treatment costs. On the other hand, even if the measured expenses do not offset the costs, treatment may be socially desirable when considering the omitted, unmeasured benefits. An often-quoted number is that for every dollar spent on drug treatment, society saves seven dollars (33). Despite potential methodological problems, the conclusion that treatment costs are fully offset by benefits to society is borne out in other studies (32). One early and interesting study took advantage of a natural experiment offered by the closing of a methadone maintenance program in an isolated region of California, leaving patients without treatment (3, 65). Savings from closing the program were nearly offset by the additional expenses in the criminal justice system and other government expenditures (109). Most economic evaluations of drug treatment use cost-effectiveness analysis (CEA). Such CEAs have addressed the question of what is the most cost-effective method or level of services of treating drug-dependent individuals (98, 99). Comparisons across treatment modalities is difficult; thus, many of the studies have compared some form of standard versus enhanced care within a single treatment modality (for reviews of CEA and cost-benefit analysis in substance abuse treatment, see 14, 29). For example, Alterman et al (1) analyzed both the costs and the outcomes of inpatient versus day hospital treatment for cocaine dependence. They found that outcomes were similar across the two groups but that the costs of day hospitalization were substantially higher. Kraft et al (55) examined the costeffectiveness of three different levels of provision of counseling in a methadone maintenance program. Using the criteria of reduced drug use as the outcome, they found that the most intensive level of counseling produced the highest level of benefits, but that the midlevel of counseling was the most cost-effective. Asking a somewhat similar question, Avants et al (4) compared standard methadone maintenance versus that enhanced by a considerably higher level of counseling. They found that the standard and the enhanced levels of counseling produced results that were insignificantly different from each other. Obviously, standard care was more cost-effective. Kraft et al found that the midlevel care

17 INNOVATIVE DRUG ABUSE TREATMENTS 265 was the most cost-effective, whereas Avants et al found that the standard care was more cost-effective. It is important to note, however, that what was referred to as standard in the Avants study was more similar to the midlevel of counseling in the Kraft study. An analysis of the Philadelphia Target City study reported increased effectiveness of adding a case manager and financial access to additional social services in both outpatient and methadone programs (69). A further study indicated that they were cost-effective (102). Cost surveys were also conducted on the treatment programs (27). Few CEA studies have been conducted on the innovations in treatment discussed above. One study, however, found that buprenorphine was a cost-effective treatment in preventing the spread of AIDS (P Barnett, C Zaric & M Brandeau, unpublished data). Another study analyzed the cost-effectiveness of a prison TC. Using recidivism to crime as the determining outcome (37, 38), they found that the TC was most cost-effective for those at high risk. The CEA literature in substance abuse is nascent. As such, there are some areas that deserve further development (12). One area is the measurement of outcomes. In CEAs, a single outcome is compared across alternative treatments or different levels of treatment (25, 35). Thus, multiple treatments are compared using a single outcome. In evaluating substance abuse treatment, the single outcome used tends to be something along the lines of days drug free. One problem with this approach is that there are many other outcomes of concern. One might imagine that reduced drug use would be a good predictor of the other outcomes. However, one study has shown that the multiple outcomes are not highly correlated with abstinence or reduced drug use (102). Thus, use of a single outcome does not capture the entire set of outcomes. Quality adjusted life years would be a potential single outcome to use, but it, too, has several drawbacks. Because a quality adjusted life year is typically developed from the perspective of suffering from a disease, it does not include the important externalities, such as reduced crime and spread of AIDS, that are key to evaluating substance abuse treatments. Society s perspective should be taken into account when evaluating ways to spend society s resources. On the other hand, the clients perspective would be a reasonable one to use in evaluating the effectiveness of programs in meeting clients needs. CBA In cost-benefit analysis (CBA), all the potential societal benefits (including costs averted) should be included (47). Benefits could include all the aspects mentioned previously: increased employment, reduced crime, better family functioning, reduced spread of AIDS, etc. In theory, a CBA should include all benefits and costs, including those that are difficult to quantify and value (28, 31, 89, 103, 116). That CBAs should include all possible costs and benefits makes it a superior method

18 266 SINDELAR FIELLIN of evaluation in theory (53), but on a practical basis, only the more easily quantifiable outcomes are included. Some outcomes are relatively easy to quantify but difficult to value, e.g. reduced crime (89), whereas others defy quantification, e.g. stabilization of a community or better parenting. The latter are typically ignored in evaluations, whereas there are attempts to better quantify the former (30). Several studies have set up the conceptual framework to conduct such studies (32, 47, 89, 103, 116). Relatively few thorough CBAs of substance abuse treatment have been conducted based on a clinical trial of a standard treatment or an innovation (40). One study (63), however, analyzed three pilot projects designed to divert criminals into treatment instead of jail using a case management model. Focusing on criminal justice costs, productivity, and medical care costs, this study concluded that the benefits outweighed the costs. Another study conducted a CBA of the Philadelphia Target City project, finding that the benefits to treatment far outweighed the costs (32). Yet anther study indicates that heroin maintenance programs are cost-beneficial (38). CONCLUSION Advances in treatment are likely to help drug users and society by reducing the overall negative impacts of illicit drug use. Innovations are being designed to increase access to care, increase effectiveness, and provide choices of treatment. These innovations need to be evaluated not just for their ability to reduce drug use but also for their impact on the multiple outcomes that are affected. Furthermore, we need to know not only whether they are effective but also whether they are cost-effective. Economic evaluations tend to find current drug treatments to be cost-effective. However, there are few studies that have calculated the cost-effectiveness of the recent innovations. Such future studies will be plagued by the problems currently encountered in evaluating standard treatments. It is difficult to measure and aggregate into common units the multiple, disparate, and sometimes hard-to-quantify outcomes, thus hindering evaluations. Furthermore, drug users, society at large, payers, and others may vary in what they consider to be high-priority outcomes. We need additional information to know which innovations should be broadly accepted, fully funded, and widely spread throughout the treatment system. Some treatments may be suitable only for a select population of drug users while others may merit widespread usage. ACKNOWLEDGMENTS We would like to thank Rebecca Dodge for her research assistance and Marie Young for her editorial assistance. This investigation was supported in part by NIAAA Research Scientist Development Award (K02 AA00164) to Yale University (Dr. Sindelar) and in part by the National Institute on Drug Abuse Physician Scientist Award (NIDA K12 DA00167) to Yale (Dr. Fiellin).

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