Inpatient versus other settings for detoxification for opioid dependence (Review)

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1 Inpatient versus other settings for detoxification for opioid dependence (Review) Day E, Ison J, Strang J This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2008, Issue 4

2 T A B L E O F C O N T E N T S HEADER ABSTRACT PLAIN LANGUAGE SUMMARY BACKGROUND OBJECTIVES METHODS RESULTS DISCUSSION AUTHORS CONCLUSIONS ACKNOWLEDGEMENTS REFERENCES CHARACTERISTICS OF STUDIES DATA AND ANALYSES APPENDICES WHAT S NEW HISTORY CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT INDEX TERMS i

3 [Intervention Review] Inpatient versus other settings for detoxification for opioid dependence Ed Day 1, Julie Ison 2, John Strang 3 1 Department of Psychiatry, Queen Elizabeth Psychiatric Hospital, Birmingham, UK. 2 Addictive Behaviours Centre, University of Birmingham- Queen Elizabeth Psychiatric Hospital, Birmingham, UK. 3 National Addiction Centre, Institute of Psychiatry, King s College London, London, UK Contact address: Ed Day, Department of Psychiatry, Queen Elizabeth Psychiatric Hospital, Mindelsohn Way, Edgbaston, Birmingham, B15 2QZ, UK. Editorial group: Cochrane Drugs and Alcohol Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 4, Review content assessed as up-to-date: 24 May Citation: Day E, Ison J, Strang J. Inpatient versus other settings for detoxification for opioid dependence. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD DOI: / CD pub2. Background A B S T R A C T There are a complex range of variables that can influence the course and subjective severity of opioid withdrawal. There is a growing evidence for the effectiveness of a range of medically-supported detoxification strategies, but little attention has been paid to the influence of the setting in which the process takes place. Objectives To evaluate the effectiveness of any inpatient opioid detoxification programme when compared with all other time-limited detoxification programmes on the level of completion of detoxification, the intensity and duration of withdrawal symptoms, the nature and incidence of adverse effects, the level of engagement in further treatment post-detoxification, and the rates of relapse post-detoxification. Search methods Electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL - The Cochrane Library Issue 2, 2008); MEDLINE (January 1966-May 2008); EMBASE (January 1988-May 2008); PsycInfo (January 1967-May 2008); CINAHL (January 1982-May 2008). In addition the Current Contents, Biological Abstracts, Science Citation Index and Social Sciences Index were searched. Selection criteria Randomised controlled clinical trials comparing inpatient opioid detoxification (any drug or psychosocial therapy) with other timelimited detoxification programmes (including residential units that are not staffed 24 hours per day, day-care facilities where the patient is not resident for 24 hours per day, and outpatient or ambulatory programmes, and using any drug or psychosocial therapy). Data collection and analysis All abstracts were independently inspected by two reviewers (ED & JI) and relevant papers were retrieved and assessed for methodological quality using Cochrane Reviewers Handbook criteria. 1

4 Main results Only one study met the inclusion criteria. This did not explicitly report the number of participants in each group that successfully completed the detoxification process, but the published data allowed us to deduce that 7 out of 10 (70%) in the inpatient detoxification group were opioid-free on discharge, compared with 11 out of 30 (37%) in the outpatient group. There was very limited data about the other outcomes of interest. Authors conclusions This review demonstrates that there is no good available research to guide the clinician about the outcomes or cost-effectiveness of inpatient or outpatient approaches to opioid detoxification. P L A I N L A N G U A G E S U M M A R Y Inpatient versus other settings for detoxification for opioid dependence Dependence on opioid drugs, such as heroin, morphine, and codeine, is a serious problem in many societies. Opioids are very difficult to quit using. The first step to quitting is detoxification, which can cause a number of painful symptoms as the drug withdraws from the body. Many people choose an inpatient detoxification program rather than trying to stop using opioids on their own. In an inpatient program, medications such as methadone can ease the symptoms of withdrawal and patients are in a secure, supportive environment with no access to opiates. However, inpatient programs are expensive and can disrupt patients lives. An increasing number of outpatient programs are available, providing medication and some support while keeping the drug user in the community. In addition to drop-in programs, there are day centres and even residential facilities which are not staffed 24 hours, unlike inpatient programs. The authors of this review looked for research comparing inpatient and other types of opiate withdrawal programs to see which is more effective. They found only one study from 1975, which had 40 participants. The study suggested inpatient therapy might be more effective than outpatient therapy in the short-term, but all of the inpatients relapsed within three months after detoxification. Since they found only one outdated study which included very few patients, the Cochrane review authors could not conclude whether inpatient treatment is more effective than outpatient or other settings. More research must be done to measure the benefits and costs of inpatient detoxification, especially for more severely dependent users. B A C K G R O U N D This review is in line with a series of Cochrane reviews of the Drug and Alcohol Review Group seeking to evaluate a variety of different therapeutic interventions for the medical management of the Opiate Withdrawal Syndrome in adults. Therefore much of the background overlaps with that of other reviews (Amato 2004; Gowing 2004a; Gowing 2004b; Gowing 2004c; Gowing 2004d) and some is reproduced unaltered. Dependence on opioid drugs is a major health and social issue in most societies. Although the prevalence of opioid use is low - for example, surveys in Australia and the European Union indicate that up two to three per cent of the general population has ever used opioids for non-medical purposes (AIHW 1999; EMCDDA 2002) - the burden of disease is substantial. The burden to the individual user and the community of opioid dependence arises from mortality (NIH 1997), which is most marked in the 15 to 34 year age group (Hall 1998), transmission of HIV and hepatitis C, health care costs, crime and law enforcement costs (EMCDDA 2002; Healey 1998; NIH 1997), as well as the less tangible costs of family disruption and lost productivity (Collins 1991). The provision of treatment has a major influence on the reduction of the harms to the individual and the community from opioid dependence. However detoxification, or managed withdrawal, is not in itself an adequate treatment for dependence (Lipton 1983; Mattick 1996). Rates of completion of withdrawal tend to be low and rates of relapse to opioid use following detoxification are high ( Milby 1988; Gossop 1989; Vaillant 1988), but withdrawal remains a required first step for many forms of longer-term treatment ( Kleber 1982). It may also represent the end point of an extensive period of treatment such as methadone maintenance or another form of substitution therapy. As such, the availability of managed withdrawal is essential to an effective treatment system. Recent reviews have highlighted the advantages and disadvan- 2

5 tages of different medical detoxification strategies (Amato 2004; Gowing 2004a; Gowing 2004b; Gowing 2004c; Gowing 2004d), and in addition there is a complex range of other variables that can influence the course and subjective severity (or intensity) of withdrawal. This includes the type of opioid used, dose taken, duration of use, general physical health, and psychological factors such as the reasons for undertaking withdrawal and fear of withdrawal (Farrell 1994; Frank 1995; Milby 1986; Preston 1985). Outcomes of a withdrawal treatment episode may also be influenced by what happens prior to detoxification, as a period of methadone maintenance treatment is likely to produce a degree of stabilisation in health and social terms that may facilitate successful withdrawal (Backmund 2001). Another key variable influencing likelihood of completion of detoxification is setting. Many people with opioid dependence have difficulty achieving abstinence in the community, citing the proximity of drug-using friends and associates, family stressors and lack of support. Treatment programmes delivered in residential settings play an important role in the national provision of treatment services for problem substance users in many countries throughout the world (Gossop 1995). Both American and British national outcome studies have provided evidence of important clinical improvements among clients treated in residential programmes (Craddock 1997; Gossop 1999; Hubbard 1989; Simpson 1982). Both have also concluded that length of time spent in treatment is an important predictor of post-treatment outcomes. However there is less known about the relative effectiveness of the inpatient setting for the detoxification phase of treatment. In the UK the national specialist inpatient drug dependence units were established in psychiatric hospitals in the late 1960s. Inpatient programmes currently provide beds in both dedicated drug dependence units and in general psychiatric wards under the care of drug dependence specialists. As part of a wider movement in psychiatry in many countries bed numbers have reduced dramatically since the 1950s. Thus, despite the steady increase in the size of the opioid problem, the number of in-patient beds available for opioid detoxification programmes has diminished broadly in parallel with the general psychiatric beds. During the same period the development of new techniques for detoxification has enabled safe detoxification from heroin and other opioid drugs in the community, and there has been a tendency to view hospital-based detoxification as expensive and unnecessary in all but the most complicated cases (DoH 1999). Outpatient detoxification clearly has some advantages in that it does not involve as much disruption to the patient and their family and offers them the possibility of continuing with their normal daily routine. It also requires them to cope with everyday situations which they will encounter on their discharge from hospital, and so may promote better coping skills. However, supplies of illicit drugs are likely to be more readily available at a time when the temptation to use will be high, possibly leading to higher relapse rates. Furthermore medical complications of detoxification are not as easily managed at home, and the process may have to be slower (Kleber 1999). A further important issue is that of cost. In simple terms detoxification in an inpatient setting appears to be much more expensive. Gossop and Strang have calculated that a three-week inpatient detoxification programme costs nine times more than an eight-week outpatient programme. However, when adjustments were made for different levels of successful outcome the costs of inpatient and outpatient treatment are almost identical (Gossop 2000). Therefore discussion of treatment costs is misleading if not informed by (and adjusted for) evidence of effectiveness. This review considers the evidence for the effectiveness of the inpatient setting as compared to non-inpatient settings for detoxification from opioids. The primary outcome of interest is whether the person is opioid-free at the end of the planned treatment period, but longer term outcomes such as engagement in treatment and relapse to opioid use will also be examined. The influence of treatment setting upon completion of detoxification is an underresearched area that has important clinical and financial implications for the treatment of opioid dependence. To the authors knowledge there has been no previous review of this topic and this review aims to highlight any gaps in the evidence base for best practice in this area. O B J E C T I V E S To evaluate the effectiveness of any inpatient opioid detoxification programme when compared with all other time-limited detoxification programmes on the level of completion of detoxification, the intensity and duration of withdrawal signs and symptoms, the nature and incidence of adverse effects experienced, the level of engagement in further treatment post-detoxification, and the rates of lapse and relapse post-detoxification. M E T H O D S Criteria for considering studies for this review Types of studies Randomised controlled clinical trials that compare inpatient treatment (as defined below) with any form of non-residential treatment. 3

6 Types of participants All patients over the age of 18 years whose primary International Codification of Diseases (ICD-10) or Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis is one of opioid dependence and who have undertaken a medically-supported detoxification procedure. The impact of withdrawal from methadone as compared with withdrawal from heroin was to be explored through a subgroup analysis if possible, as was the effect of different detoxification strategies such as methadone reduction, buprenorphine reduction, alpha-2 adrenergic agonists or symptomatic treatment. Types of interventions (1) Experimental interventions Inpatient opioid detoxification - any time-limited treatment for opioid dependence where the clearly expressed aim at the outset is detoxification (i.e. becoming opioid-free) and where the patient is resident for 24 hours per day in a facility that also has staff present throughout this period. (2) Control interventions All other time-limited detoxification programmes including residential units that are not staffed 24 hours per day day-care facilities where the patient is not resident for 24 hours per day outpatient or ambulatory programmes Types of outcome measures Primary Outcomes (1) completion of withdrawal, as measured by self-report data and urinary or saliva analysis (2) intensity and duration of signs and symptoms and overall withdrawal syndrome experienced, as measured by either objective or self-completed measures (3) the nature and incidence of adverse effects experienced as a result of medication used in the detoxification procedure, as measured by either objective or self-completed measures (4) engagement in further treatment post-detoxification, as measured by attendance at treatment sessions (5) post-detoxification outcomes such as rates of lapse and relapse, as measured by self-report data and urinary or saliva analysis Secondary Outcomes (6) cost of the treatment (where reported) in order to make comparisons of cost per completed detoxification between inpatient and outpatient settings. Search methods for identification of studies Electronic searches We searched Cochrane Drugs and Alcohol Group Register of Trials (March 2004), Cochrane Central Register of Controlled Trials (CENTRAL - The Cochrane Library Issue 2, 2008), MEDLINE (OVID - January 1966 to May 2008), EMBASE (OVID -January 1988 to May 2008), PsycInfo (OVID -January 1967 to May 2008), CINAHL (OVID -January 1982 to May 2008). To identify studies included in this review, we used detailed search strategies for each database searched to take account of differences in controlled vocabulary and syntax rules, see Appendix 1; Appendix 2; Appendix 3; Appendix 4; Appendix 5; Appendix 6. In addition the Current Contents, Biological Abstracts, Science Citation Index and Social Sciences Index were searched. Searching other resources We handsearched the reference lists of retrieved studies, reviews and conference abstracts. We contacted authors of included studies and experts in the field wherever possible to find out if they knew of any other published or unpublished controlled trials assessing the effectiveness of opioid detoxification in different treatment settings. All searches included non-english language literature. Those studies with English abstracts were assessed for inclusion on the basis of the abstract. No non-english language abstracts were considered to meet inclusion criteria. Data collection and analysis Selection of studies Two independent authors (ED, JI) undertook a systematic examination of all references retrieved by the search. The two authors independently selected trials assessing the effectiveness of opioid detoxification in different treatment settings. Data extraction and management Two authors (ED and JI) independently extracted data. Any disagreement was discussed and the decisions documented. Where necessary, we contacted the authors of the studies to help resolve the issue. The summary statistics required for each trial and each outcome for continuous data were the mean change from baseline, the standard error of the mean change, and the number of patients for each treatment group at each assessment. Where changes from baseline were not reported, the mean, standard deviation and the number of patients for each treatment group at each time point was extracted. For binary data the numbers in each treatment group and the numbers experiencing the outcome of interest were sought. The baseline assessment was defined as the latest available assessment prior to randomization, but no longer than two months prior. 4

7 For each outcome measure, we sought data on every participant assessed. To allow an intention-to-treat analysis, the data was sought irrespective of compliance, whether or not the patient was subsequently deemed ineligible, or otherwise excluded from treatment or follow-up. If intention-to-treat data were not available in the publications, on-treatment or the data of those who completed the trial were sought and indicated as such. Data synthesis As only one study met the inclusion criteria, no meta-analysis was performed. R E S U L T S Assessment of risk of bias in included studies The quality of the methodology of each selected trial was be examined with reference to Cochrane Collaboration guidelines (Alderson 2004) on the basis of the method of allocation concealment and was rated as follows: A. Low risk of bias: adequate allocation concealment, i.e. central randomisation (e.g. allocation by a central office unaware of participant characteristics), computer file that can be accessed only after the characteristics of an enrolled participant have been entered or other description containing elements suggesting adequate concealment. B. Moderate risk of bias: unclear allocation concealment, in which the authors either did not report an allocation concealment approach at all or report an approach that did not fall in the category A or C. C. High risk of bias: inadequate allocation concealment, such as alternation or reference to case numbers or dates of birth. D. When allocation concealment has not been used to evaluate the quality of the study (i.e when it does not apply because of a study design other than RCT). Methodological quality was not used as a criterion for inclusion in the review, but its impact is considered in the discussion section. Measures of treatment effect The RevMan software package was to be used to perform the metaanalysis for continuous and dichotomous outcome measures, although ultimately the data available did not allow such an analysis. We aimed to analyse both the pooled data and by patient subgroup: Type of detoxification setting (eg inpatient, day care, outpatient) Type of medication used (eg methadone reduction, alpha-2 agonists) Furthermore we also aimed to analyse data by: Drug of dependence - heroin or methadone Poly-drug use - the effects of use of alcohol and other drugs Concurrent physical & psychiatric illness Time to outcome measure - short-term (up to one month), medium term (one month up to six months) and long-term (longer than six months) Description of studies See: Characteristics of included studies; Characteristics of excluded studies. (1) Excluded studies One study was identified from the abstract as potentially suitable ( Vidjak 2003) in that it involved a systematic allocation of 90 heroin addicts to either methadone, hospital, or therapeutic community treatment. However, on analysis of the paper it became clear that the study was retrospective and did not involve randomisation. In a second study (Gossop 1986) the 60 participants (45 men and 15 women) were all patients of a Drug Dependence Clinic, and most (47, 78%) were primarily dependent on heroin. They were assigned the participants to one of four groups: the randomised outpatient group, the randomised inpatient group, the preferred outpatient group, and the preferred inpatient group. All participants were asked if they were prepared to accept either inpatient or outpatient withdrawal. Those subjects who were willing to accept either were then assigned to one of the two randomised groups. Those who expressed a strong preference for inpatient or outpatient withdrawal were assigned to the appropriate preference group. The inpatient treatment programme lasted for 21 days. The outpatient programme lasted for 56 days and entailed weekly attendance at the clinic for counselling. Both withdrawal schemes used oral methadone, the dose of which was reduced on a daily basis using a linear (equal dose) reduction model. The principal aim was to achieve abstinence at the end of the supervised withdrawal regime, and abstinence was confirmed by urine analysis. A total of 25 (81%) of the 31 participants in the inpatient withdrawal group were successfully withdrawn from opioid drugs (and all other drugs, including alcohol), whereas only 5 (17%) of the 29 participants in the outpatient withdrawal group achieved abstinence. However, only 20 of the total sample of 60 were actually randomised, and although the authors comment on the complete failure of the randomised outpatient group, the number of participants actually randomised to inpatient or outpatient treatment is not reported. The study was therefore excluded from the review. (2) Included studies Only one study was identified that met the inclusion criteria for the review (Wilson 1975). (a) Participants In Wilson 1975 the participants were all physically dependent on heroin and had pharmacological evidence of current drug use 5

8 through urinalysis or clinical evidence of the opioid withdrawal syndrome. The 40 participants had a mean age of 22 years, and although the sex ratio is not reported the authors comment that the group tended to be white, single and male. For nearly 75% of the sample this was the first withdrawal treatment experience. (b) Interventions Wilson 1975 randomly assigned participants to hospital detoxification or outpatient detoxification. The hospital detoxification group was supervised by three psychiatrists on an open ward of an acute psychiatric treatment service in a general hospital. The detoxification was performed using methadone, although exact details of the process are not reported beyond that the psychiatrists used their usual narcotic detoxification procedure with the single limitation that dosage of methadone would not exceed 40mg in any 24-hour period. No prescribed length of treatment was imposed on the hospital participants, and those who felt stabilised or requested to leave were discharged. Participants were expected to participate in ward activities and group meetings. The outpatient detoxification group also received methadone, and were supervised by one psychiatrist. All methadone doses were given under the direct supervision of the clinic nurse, and the procedure occurred in a fixed 10-day period. Withdrawal was accomplished by starting with a flexible dose of 10-20mg of methadone and stabilising at a maximum of 40mg daily on day 2-3. Dosage was then individualised, but no more than 30mg of methadone was administered on days 4 or 5, no more than 20mg on days 6 or 7, and no more than 10mg on days 8, 9, or 10. All participants were offered individual counselling by the psychiatrist and clinic nurses. Both groups were also offered supportive medication as clinically indicated. (c) Outcomes Wilson 1975 reported drug use during treatment (as measured by self-report and urine analysis) and the length of the heroin-free period after detoxification treatment. The authors also reported the average cost of both treatment modalities. Risk of bias in included studies (1) Randomization Wilson 1975 reported randomly allocating participants to different treatment modalities, but did not describe the method used to generate random allocation. Furthermore, significant methodological problems surrounding randomisation were identified. The authors reported randomly allocating patients accepted for treatment to either hospital or outpatient detoxification, but also that some patients refused treatment rather than accept hospitalisation. This may explain why 30 of the 40 study participants were in the outpatient treatment group and only 10 were in the inpatient group. (2) Blinding Wilson 1975 did not report that staff collecting or analysing the outcome data were blinded to the participants treatment modality. (3) Losses to follow up Although it is not explicitly reported, it would appear that approximately 20 participants dropped out of the Wilson 1975 study after randomisation and prior to starting inpatient treatment. If this was the case, the results are not reported on an intention-totreat basis and are therefore likely to be biased in favour of inpatient treatment. As the exact number of dropouts is not reported, it would not be appropriate to subject the study to further quantitative analysis. Effects of interventions (1) Completion of withdrawal, as measured by self-report data and urinary or saliva analysis The Wilson 1975 study does not explicitly report the number of participants in each group that successfully completed the detoxification process. The authors reported data about relapse to heroin use after detoxification treatment, and from this it is possible to deduce that 7 out of 10 (70%) in the inpatient detoxification group were opioid-free on discharge, compared with 11 out of 30 (37%) in the outpatient group. However a number of participants also refused treatment rather than accepting hospitalisation (although the exact number is not reported), and so the completion rate in the inpatient sample calculated on an intention-to-treat basis would certainly have been much lower. (2) Intensity and duration of signs and symptoms and overall withdrawal syndrome experienced, as measured by either objective or self-completed measures The included study (Wilson 1975) did not report the effect of the intervention on these outcomes. (3) The nature and incidence of adverse effects experienced as a result of medication used in the detoxification procedure, as measured by either objective or self-completed measures The included study (Wilson 1975) did not report the effect of the intervention on these outcomes. (4) Engagement in further treatment post-detoxification, as measured by attendance at treatment sessions The included study (Wilson 1975) did not report the effect of the intervention on these outcomes. (5) Post-detoxification outcomes such as rates of lapse and relapse, as measured by self-report data and urinary or saliva analysis The Wilson 1975 study mentioned levels of treatment attendance after the detoxification period, although this was not specified as an outcome measure at the outset of the study. Three out of 10 (30%) in the hospital sample were lost to follow-up. Of the remaining seven, one resumed heroin use within 24 hours of discharge, one within one week, two within one month, two within two months, 6

9 and one within three months. In the outpatient sample 10 (33%) of the participants were lost to follow-up, and one patient assigned to the group did not initiate treatment. A further eight (27%) never stopped using heroin despite receiving methadone. Two reported return to heroin use within one week of treatment, five within two months, and one resumed without specifying the time period. Two participants were still heroin-free when last contacted two months after treatment. Unfortunately the authors did nor report the frequency of contact with the participants in the follow-up period, and the method of determining relapse to heroin (urinary analysis or self-report) is not specified. (6) The Cost of Treatment Wilson 1975 reported the average cost of treatment in the outpatient group as US$10 per day or US$100 for a 10-day detoxification programme (including the cost of intake procedures, laboratory work and medications). The average cost of the hospital treatment was US$91 per day or US$496 for a treatment programme with an average patient stay of 5.4 days. D I S C U S S I O N Inpatient detoxification is an expensive process requiring considerable resources, and therefore it is surprising that so few clinical studies have examined its effectiveness. Both studies produced by the literature searching process were small and had methodological limitations, and only one met the inclusion criteria for the review. Both made use of methadone reduction as a detoxification method, and newer techniques are now available that have generally increased opioid detoxification rates in the community setting (Akhurst 1999). Neither study reports longer-term outcomes in any detail, so it is difficult to determine whether inpatient detoxification has other benefits. Non-randomised studies comparing inpatients and outpatients typically show that the former have more severe substance use histories and a greater prevalence of medical, psychosocial and vocational difficulties, including less social stability, more unemployment and a greater preponderance of medical and psychiatric disorders (DoH 1996). However, these data reflect referral patterns and not which populations fare best in each setting. Inpatient detoxification is generally considered to be indicated for those individuals who have too many adverse prognostic features to be successful at detoxification as an outpatient (DoH 1999). In practice, not only are such individuals also the least likely to complete detoxification as an inpatient, but they are often especially unable to tolerate the constraints of a hospital setting. This has been described as the severity paradox, in which success is unlikely in those who are particularly considered to require the approach (Seivewright 2000), and is likely to have arisen due to economic restraints rather than clinical evidence. Despite evidence that inpatient provision for drug detoxification is diminishing (Mark 2002), this review suggests that practice in the field continues to be lead by clinical experience and intuition rather than evidence. A U T H O R S C O N C L U S I O N S Implications for practice There is a lack of good quality research evidence available to guide practice in this area. Detoxification is an essential first step in achieving lifelong abstinence, but little attention has been paid to the effect of treatment setting (Mattick 1996). Given the potential cost of inpatient treatment, it is perhaps surprising that a search of the world literature in this area yielded only two randomised controlled trials, both with significant methodological limitations. The only real conclusion that can be drawn is that there is very little available research to guide the clinician about the longerterm outcomes or cost-effectiveness of inpatient or outpatient approaches. Implications for research Reviews in the alcohol research field have concluded that there is no evidence for the superiority of inpatient over outpatient treatment of alcohol abuse (Miller 1986). However, extrapolation of these results to the treatment of other substance users must be done with caution, and better designed research is needed to confirm this conclusion for opioid dependent individuals. The randomised controlled trial is usually the methodology of choice for determining which treatment option is best. However, in the case of inpatient opioid detoxification there is a problem of equipoise, whereby the patients who theoretically might benefit most from the treatment are often excluded from randomised trials. Patients with opioid dependence and co-existing mental illness, severe social isolation or dependence on other substances are often considered too unwell to attempt detoxification anywhere else other than an inpatient setting. Therefore they are often excluded from clinical trials, and this is likely to reduce any possible advantages that treatment in an in-patient setting may convey (Finney 1996). Furthermore, the few studies that have looked at the effect of setting on detoxification outcomes have involved too few participants to provide sufficient statistical power to detect potential differences. It is important to remember that a failure to detect a difference in these circumstances is not the same as proving that no benefit exists. From a clinician s perspective there is a small group of patients who will benefit from undertaking detoxification in more supportive settings. Therefore, one profitable research strategy may be to develop good quality prospective studies to look at the outcomes of patients with complex problems after inpatient admission. This would allow the testing of hypotheses concerning predictive factors for good treatment outcomes in particular populations (e.g. 7

10 people with a co-existing severe mental illness, people dependent on more than one substance). There is also some evidence that detoxification in an inpatient environment may increase the likelihood of engaging the patient in longer term care (Ghodse 2002), and such a prospective cohort study would be suitable for examining such issues. A C K N O W L E D G E M E N T S None R E F E R E N C E S References to studies included in this review Wilson 1975 {published data only} Wilson BK, Elms RR, Thomson CP. Outpatient versus hospital methadone detoxification: An experimental comparison. International Journal of the Addictions 1975;10 (1): References to studies excluded from this review Gossop 1986 {published data only} Gossop M, Johns A, Green L. Opiate withdrawal: inpatient versus outpatient programmes and preferred versus random assignment to treatment. British Medical Journal 1986;293 (6539): Vidjak 2003 {published data only} Vidjak N. Treating heroin addiction: comparison of methadone therapy, hospital therapy without methadone, and therapeutic community. Croatian Medical Journal 2003;44(1): Additional references AIHW 1999 Australian Institute of Health & Welfare National Drug Strategy Household Survey: First Results. Canberra: AIHW, Akhurst 1999 Akhurst JS. The use of lofexidine by drug dependency units in the United Kingdom. European Addiction Research 1999; 5(1):43 9. Alderson 2004 Alderson P, Green S, Higgins JPT, editors. Cochrane Reviewers s Handbook [updated March 2004]. In: The Cochane Library [database on CDROM]. The Cochrane Collaboration. Chichester, UK: John Wiley & Sons, Ltd; Amato 2004 Amato L, Davoli M, Ferri M, Ali R. Methadone at tapered doses for the management of opioid withdrawal. Cochrane Database of Systematic Reviews 2004, Issue 3. [DOI: / ] Backmund 2001 Backmund M, Meyer K, Eichenlaub D, Schutz CG. Predictors for completing an inpatient detoxification program among intravenous heroin users, methadone substituted and codeine substituted patients. Drug and Alcohol Dependence 2001;64: Collins 1991 Collins DJ, Lapsley HM. Estimating the economic costs of drug abuse in Australia. Canberra: Australian Government Publishing Service, Craddock 1997 Craddock SG, Rounds-Bryant JL, Flynn PM, Hubbard RL. Characteristics and pre-treatment behaviours of clients entering drug abuse treatment American Journal of Drug and Alcohol Dependence 1997;23(1): DoH 1996 Department of Health. Task Force to Review Services for Drug Misuers. London: Department of Health, DoH 1999 Department of Health. Drug Misuse and Dependence - Guidelines on Clinical Management. Norwich: The Stationery Office, DSM-IV American Psychiatric Association (Pub.). Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TM. Washington DC: American psychiatric association, EMCDDA 2002 European Monitoring Centre for Drugs and Drug Addiction. Annual report on the state of the drugs problem in the European Union and Norway. Luxembourg: Office for Official Publications of the European Communities, Farrell 1994 Farrell M. Opiate withdrawal. Addiction 1994;89(11):

11 Finney 1996 Finney JW, Hahn AC, Moos RH. The effectiveness of inpatient and outpatient treatment for alcohol abuse: the need to focus on mediators and moderators of setting effects. Addiction 1996;91(12): Frank 1995 Frank L, Pead J. New concepts in drug withdrawal: a resource handbook. Melbourne: University of Melbourne, Ghodse 2002 Ghodse AH, Reynolds M, Baldacchino AM, Dunmore E, Byrne S, Oyefeso A, et al.treating an opiate-dependent inpatient population: A one-year follow-up study of treatment completers and non-completers. Addictive Behaviours 2002;27: Gossop 1989 Gossop M, Green L, Phillips G, Bradley B. Lapse, relapse and survival among opiate addicts after treatment. A prospective follow-up study. British Journal of Psychiatry 1989;154: Gossop 1995 Gossop M. The treatment mapping survey: a descriptive study of drug and alcohol treatment responses in 23 countries. Drug and Alcohol Dependence 1995;39:7 14. Gossop 1999 Gossop M, Marsden J, Stewart D, Rolfe A. Treatment retention and 1 year outcomes for residential programmes in England. Drug and Alcohol Dependence 1999;57: Gossop 2000 Gossop M, Strang J. Price, cost and value of opiate detoxification treatments. Reanalysis of data from two randomised trials. British Journal of Psychiatry 2000;177: Gowing 2004a Gowing L, Farrell M, Ali R, White J. Alpha2 adrenergic agonists for the management of opioid withdrawal. Cochrane Database of Systematic Reviews 2004, Issue 3. [DOI: / ] Gowing 2004b Gowing L, Ali R, White J. Buprenorphine for the management of opioid withdrawal. Cochrane Database of Systematic Reviews 2004, Issue 3. [DOI: / ] Gowing 2004c Gowing L, Ali R, White J. Opioid antagonists with minimal sedation for opioid withdrawal. Cochrane Database of Systematic Reviews 2004, Issue 3. [DOI: / ] Gowing 2004d Gowing L, Ali R, White J. Opioid antagonists under heavy sedation or anaesthesia for opioid withdrawal. Cochrane Database of Systematic Reviews 2004, Issue 3. [DOI: / ] Hall 1998 Hall W, Darke S. Trends in opiate overdose deaths in Australia Drug and Alcohol Dependence 1998; 52:71 7. Healey 1998 Healey A, Knapp M, Astin J, Gossop M, Marsden J, Stewart D, et al.economic burden of drug dependency. Social costs incurred by drug users at intake to the National Treatment Outcome Research Study. British Journal of Psychiatry 1998; 173: Hubbard 1989 Hubbard RL, Marsden ME, Rachal JV, Chapel Hill, Drug Abuse Treatment: A National Study of Effectiveness. Chapel Hill: University of North Carolina Press, Kleber 1982 Kleber HD, Riordan CE. The treatment of narcotic withdrawal: a historical review. Journal of Clinical Psychiatry 1982;43(6):30 4. Kleber 1999 Kleber HD. Opioids: Detoxification. In: Galanter M, Kleber HD editor(s). Textbook of Substance Abuse Treatment. Washington DC: American Psychiatric Press, 1999: Lipton 1983 Lipton D, Maranda M. Detoxification from heroin dependency: An overview of method and effectiveness. Advances in Alcohol and Substance Abuse 1983;2(1): Mark 2002 Mark TL, Dilonardo JD, Chalk M, Coffey RM. Trends in inpatient detoxification services. Journal of Substance Abuse Treatment 2002;23: Mattick 1996 Mattick RP, Hall W. Are detoxification programmes effective?. Lancet 1996;347: Milby 1986 Milby JB, Gurwitch RH, Wiebe DJ, Ling W, McLellan AT, Woody GE. Prevalence and diagnostic reliability of methadone maintenance detoxification fear. American Journal of Psychiatry 1986;143(6): Milby 1988 Milby J. Methadone maintenance to abstinence. How many make it?. The Journal of Nervous and Mental Disease 1988;176(7): Miller 1986 Miller WR, Hester RK. Inpatient alcoholism treatment: Who benefits?. American Psychologist 1986;41(7): NIH 1997 NIH Consensus Development Statement. Effective Medical Treatment of Opiate Addiction. National Institutes of Health, Preston 1985 Preston KL, Bigelow GE. Pharmacological advances in addiction treatment. International Journal of the Addictions 1985;20(6&7):

12 Seivewright 2000 Seivewright N. Community Treatment of Drug Misuse: More Than Methadone. Cambridge: Cambridge University Press, Simpson 1982 Simpson DD, Sells SB. Effectiveness for treatment of drug abuse: an overview of the DARP research programme. Advances in Alcohol and Substance Abuse 1982;2(1):7 29. Vaillant 1988 Vaillant GE. What can long-term follow-up teach us about relapse and prevention of relapse in addiction?. British Journal of Addiction 1988;83(10): Indicates the major publication for the study 10

13 C H A R A C T E R I S T I C S O F S T U D I E S Characteristics of included studies [ordered by study ID] Wilson 1975 Methods Participants Interventions Outcomes Notes Participants accepted for treatment were randomly assigned to hospital detoxification (HD) or outpatient detoxification (OPD). The hospital unit was an open ward of an acute psychiatric treatment service in a general hospital 40 participants Over 18 years old (mean age 22 years) Seeking narcotic (heroin) detoxification Criteria for admission to treatment included evidence of physical dependence on narcotics and pharmacological evidence of current drug use through urinalysis or clinical evidence of the narcotic withdrawal syndrome 33% were employed 40% were living with their parents (1) Hospital detoxification - supervised by 3 psychiatrists and followed their normal detoxification procedure with the single limitation that dosage of methadone would not exceed 40mg in any 24-hour period. No prescribed length of treatment was imposed, and patients who felt stabilized or requested to leave were discharged. (2) Outpatient detoxification - supervised by 1 psychiatrist. Detoxification was accomplished in a 10 day period by starting with a flexible dose of 10 to 20mg of methadone and stabilizing at a maximum dose of 40mg daily on the second or third day of treatment. Dosage was individualized, but no more than 30mg of methadone was administered on days 4 or 5, no more than 20mg on days 6 or 7, and no more than 10mg on days 8,9, or 10. All participants were offered individual counselling by the psychiatrist and clinic nurses. Both groups were offered supportive medication as clinically indicated Hospital detoxification - 7 out of 10 (70%) subjects were drug free at the end of the detoxification period Outpatient detoxification - 11 out of 30 (37%) participants were drug free at the end of the detoxification period One third of both groups were lost to follow-up. All hospital detoxification patients had returned to heroin use within 3 months of treatment All but two of the outpatient detoxification patients had returned to heroin use within 2 months of treatment, and one of these was in prison Some patients refused treatment rather than accept hospitalisation. Ten patients were assigned to HD and 30 patients to OPD, suggesting that about 20 patients dropped out of the HD group Risk of bias Item Authors judgement Description Allocation concealment? Unclear B - Unclear 11

14 Characteristics of excluded studies [ordered by study ID] Study Gossop 1986 Vidjak 2003 Reason for exclusion 60 participants (45 men, 15 women), all physically dependent on opiates and asking to be withdrawn. Participants were asked if they were prepared to accept either inpatient or outpatient opiate withdrawal, and those who were willing to do so were assigned randomly to the randomised inpatient or randomised outpatient group. Those who expressed a strong preference were assigned to the preferred outpatient or preferred inpatient group. It is not possible to calculate from the paper the number of participants who completed in the randomised inpatient or randomised outpatient group Not a randomised controlled trial, but rather a post-treatment construction of three samples 12

15 D A T A A N D A N A L Y S E S This review has no analyses. A P P E N D I C E S Appendix 1. Cochrane Drugs and Alcohol Group Register of Trials search strategy diagnosis=opioid and intervention=setting Appendix 2. CENTRAL search strategy 1. substance-related disorders:me 2. Opiod-related disorders:me 3. #1 or #2 4. addict* 5. abus* 6. use* 7. addict* 8. disorder* 9. #4 or #5 or #6 or #7 or #8 10. SUBSTANCE WITHDRAWAL SYNDROME:ME 11. Detoxification 12. #10 or # opiat* 14. opioid* 15. diacetylmorphine 16. morphin* 17. HEROIN 18#13 OR #14 OR #15 OR #16 or # INPATIENTS:ME 20. OUTPATIENTS:ME 21. HOSPITALIZATION:ME 22. hospital* 23. inpatient* 24. #19 OR #20 OR #21 OR #22 OR # #9 AND #18 AND #24 13

16 Appendix 3. MEDLINE search strategy 1. exp substance-related disorders/ 2. opiod-related disorders/ 3. (addict$ or abus$ or use$).ab,ti 4. 1 or 2 or 3 5. (morphine.ab,ti or opioid$ or opiate*or heroin).ab,ti 6. exp heroin/ 7. 5 or 6 8. exp Inpatients/ 9. exp Outpatients/ 10. exp Hospitals 11. hospital$.ab,ti 12. inpatient$.ab,ti 13. setting.mp or 9 or 10 or 11 or 12 or and and limit 15 to human Appendix 4. EMBASE search strategy 1. exp narcotic dependence/ 2. (addict$ or abus$ or use$).ab,ti 3. 1 or 2 4. exp Withdrawal syndrome/ 5. exp Drug detoxification/ 6. detoxification.ab,ti 7. 4 or 5 or 6 8. exp morphine derivative 9. morphine.ab,ti 10. exp diamorphine/ 11. exp opiate/ 12. opioid.ab,ti or 9 or 10 or 11 or exp Hospital Patient/ 15. exp Outpatient/ 16. Inpatient.ab,ti 17. setting*.ab,ti or 15 or 16 or limit 18 to human Appendix 5. PsycInfo search strategy 1. exp drug addiction 2. (addict$ or abus$ or dependen$).ti,ab,sh or 2 4. exp detoxification/ 5. 3 or 4 6. exp morphine/ 7. exp heroin/ 8. exp opiates/ 14

17 9. opioid$.ab,ti or 7 or 8 or inpatient.ab,ti 12. exp outpatient treatment/ 13. exp Hospitals/ 14. setting.ab,ti or 12 or 13 or and and limit 17 to human Appendix 6. CINAHL search strategy 1. exp Substance abuse/ 2. exp Substance dependence/ 3. (addict$ or abus$ or dependen$).ti,ab,sh or 2 or 3 5. detoxification 6. exp Substance Withdrawal Syndrome 7. 5 or 6 8. exp opium/ 9. (opioid$ or heroin or morphine).ab,ti or exp Inpatient/ 12. exp Hospitals/ 13. setting.ab,ti or 12 or and and limit 17 to human W H A T S N E W Last assessed as up-to-date: 24 May Date Event Description 26 May 2008 New search has been performed new search, no new trials 25 March 2008 Amended Converted to new review format. 15

18 H I S T O R Y Protocol first published: Issue 1, 2004 Review first published: Issue 2, 2005 Date Event Description 4 January 2005 New citation required and conclusions have changed Substantive amendment C O N T R I B U T I O N S O F A U T H O R S Two independent reviewers (ED, JI) undertook a systematic examination of all references retrieved by the search. The two reviewers (ED, JI) independently selected trials assessing the effectiveness of opioid detoxification in different treatment settings, did the quality assessment and wrote the review. JS supervising and commented on the draft. D E C L A R A T I O N S O F I N T E R E S T Two of the authors (ED, JS) have clinical responsibilities for clinical services that provide opioid detoxification in both inpatient and outpatient settings. S O U R C E S O F S U P P O R T Internal sources Birmingham and Solihull Mental Health NHS Trust, UK. External sources No sources of support supplied I N D E X T E R M S Medical Subject Headings (MeSH) Hospitalization; Methadone [therapeutic use]; Narcotics [therapeutic use]; Opioid-Related Disorders [ rehabilitation] 16

19 MeSH check words Humans 17

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