Treatment of Prescription Opioid Dependence

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1 Treatment of Prescription Opioid Dependence Roger D. Weiss, MD Chief, Division of Alcohol and Drug Abuse McLean Hospital, Belmont, MA Professor of Psychiatry, Harvard Medical School, Boston, MA

2 Prescription Opioid Dependence: A Growing Problem In 2010, 5.1 million persons aged 12 years used prescription opioids nonmedically in the past month (1.7% of the population) 2.0 million were new users of Rx opioids Among new users of illicit substances, this was the second largest number of past-year initiates second only to marijuana by about 400,000 people in 2010 Substance Abuse and Mental Health Services Administration. Accessed January 10, 2012.

3 Past Month Nonmedical Use of Types of Psychotherapeutic Drugs Among Persons Aged 12 Years: 2002 to Significant difference between this estimate and the 2010 estimate (p<.05) Substance Abuse and Mental Health Services Administration. Accessed January 10, 2012.

4 Percent Nonmedical Prescription Opioid Use 2010 Monitoring The Future Study: Annual Use Prevalence Among 12th Graders 10 12th Graders '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 Substance Abuse and Mental Health Data Archive. Accessed January 11, 2012

5 Admissions, No. Opioid Admissions Age 12 to 17 Years Treatment Episode Data Set (TEDS): Heroin Rx Opioids '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 ' Substance Abuse and Mental Health Services Administration. Accessed January 12, 2012.

6 Previous Research on Treatment of Opioid Dependence Most studies examine heroin addicts receiving methadone maintenance treatment; favor maintenance pharmacotherapy and more counseling Findings from counseling research in methadone treatment programs may not generalize to office-based buprenorphine treatment Findings regarding length of pharmacotherapy for heroin addiction may not generalize to prescription opioid addiction

7 Previous Research on Counseling With Buprenorphine Treatment Most studies have focused on primarily heroindependent populations Fiellin et al. (2006) 1 : Only study to examine optimal intensity of counseling for patients receiving officebased buprenorphine maintenance treatment Only 17% of population dependent on prescription opioids, however 20-minute vs 45-minute weekly counseling session No difference in outcomes between counseling groups 1. Fiellin DA et al. N Engl J Med. 2006;355(4):

8 Dependence on Heroin vs Prescription Opioids We can t assume that pts with prescription opioid dependence (POD) will have the same course of illness and response to treatment as those dependent on heroin Moore et al. (2007) 1 : POD patients more likely to 1. Earn more income 2. Be hepatitis C-negative 3. Complete treatment 4. Have a higher % of opioid-negative urines 1. Moore BA et al. J Gen Intern Med. 2007; 22(4):

9 Prescription Opioid Addiction Treatment Study (POATS) Compared treatments for prescription opioid dependence, using buprenorphine-naloxone (bup-nx) of varying durations and counseling of varying intensities Conducted as part of National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) at 10 participating sites across the United States Largest study ever conducted for prescription opioid dependence 653 participants enrolled Study began June 2006, last visit held in July 2009 Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

10 NIDA Clinical Trials Network (CTN) A partnership between academic research centers and community drug abuse treatment programs (CTPs) to develop and implement multisite clinical research studies in CTPs

11 NIDA CTN Nodes

12 POATS Design Two-phase adaptive treatment research design Patients begin with 4-week taper of bup-nx Randomly assigned to standard medical management (SMM) or SMM + individual opioid drug counseling (SMM + ODC) Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

13 POATS Design Patients who succeed in phase 1 (1-month taper plus 2-month follow-up) are successfully finished with the study Patients who relapse may go into phase 2 3 months of bup-nx stabilization 1-month taper off bup-nx 2 months of follow-up Re-randomized to SMM or SMM + ODC in phase 2 Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

14 Key Features of POATS Design Adaptive treatment research design approximates clinical practice Start with a less intensive treatment to see if it works Try a more intensive treatment if first treatment doesn t work Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

15 Phase 1 (up to 12 weeks)

16 Phase 2 (24 weeks)

17 Study Design

18 POATS Study Questions Does adding individual drug counseling to bup-nx + SMM improve outcome? May be a proxy for drug abuse treatment program vs office-based opioid treatment, using bup-nx What length of bup-nx is best for these pts? 1 month? 3 months? Maintenance?

19 Key Eligibility Criteria DSM-IV diagnosis of opioid dependence, not just physical dependence 20 days opioid use in past 30 days Additional substance use disorders eligible if not requiring immediate medical treatment Nonpsychotic, psychiatrically stable

20 Complicating Factors in Defining a Study Population of Subjects With Prescription Opioid Dependence Heroin use Chronic pain

21 Heroin Use Most previous studies of opioid dependence had included mostly subjects with heroin dependence, with some subjects who had POD We wanted to identify a new and distinct population of subjects with POD However, We wanted the population to be representative of those dependent upon prescription opioids, some of whom also use heroin to varying extents

22 Heroin-related Exclusion Criteria >4 days of heroin use in past 30 days Ever met criteria for opioid dependence as a result of heroin use alone Ever injected heroin Potter JS et al. Contemp Clin Trials. 2010;31(2):

23 Pain-Related Inclusion/Exclusion Criteria Pts prescribed opioids for pain were included only if approved by prescribing MD Cancer pain excluded No traumatic or major pain event within past 6 mos Had to express interest in stopping opioids Weiss et al., Am J Addictions, 2010

24 Heroin and Chronic Pain Design Decisions Patients were stratified on the basis of Presence/absence of current chronic pain Lifetime history of heroin use

25 Treatments

26 Buprenorphine-Naloxone Patients received 4 to 12 mg on day 1 Allowable dose was 8 to 32 mg/day Target dose was 16 mg/day, but flexible dosing allowed Once-daily dosing recommended Lost prescriptions were not refilled.

27 Standard Medical Management Manual-based treatment Weekly visits with buprenorphinecertified MD Initial visit: 45 to 60 minutes; follow-up visits 15 to 20 minutes Assess substance use, craving, and medication response Recommend abstinence, self-help

28 Opioid Drug Counseling Manual-based drug counseling, based on previous successful counseling manuals 45 to 60 minute visits Phase 1: 2 /week Phase 2: 2 /week for 6 weeks, 1 /week for 6 weeks

29 Opioid Drug Counseling (cont) Education about addiction and recovery Recommend abstinence Recommend self-help Skills-based interactive exercises and take-home assignments Covers wider range of relapse prevention issues than SMM in greater depth: high-risk situations, managing emotions, and dealing with relationships

30 Description of the Study Population (N=653 in phase 1)

31 Baseline Stratification Factors Lifetime heroin use 23.0% Current chronic pain 42.0% Chronic pain defined as self-report of non-withdrawal pain, beyond the usual aches and pains for > 3 months.

32 Baseline Sociodemographic Characteristics Female 40.0% White 91.3% Hispanic 4.7% Age, mean (SD), years 33.2 (10.2) No observable significant differences between SMM and SMM + ODC across baseline characteristics

33 Baseline Sociodemographic Characteristics (cont) Employment Full-time 411 (62.9%) Part-time 65 (10.0%) Unemployed 82 (12.6%) Marital status Never 326 (49.9%) Married 180 (27.6%) Divorced 101 (15.5%) Education, mean (SD), years 13.0 (2.2) No significant differences between SMM and SMM + ODC

34 Baseline Psychiatric Characteristics Major Depressive Disorder (CIDI) Lifetime 41% Current 22% PTSD (CIDI) Lifetime 18% Current 12% Beck Depression Inventory, mean (SD) 22 (12) No significant differences between SMM and SMM + ODC

35 Prevalence of Other SUDs Alcohol Cannabis Cocaine Sedative/hypnotic Stimulant Past Year Lifetime Abuse 10% 60% Dependence 4% 27% Abuse 11% 47% Dependence 5% 15% Abuse 6% 32% Dependence 3% 18% Abuse 10% 25% Dependence 6% 10% Abuse 3% 22% Dependence 2% 11%

36 Prevalence of Other SUDs (cont) Days of use, past 30 days Mean (SD) Opioid analgesics 28.1 (4.0) Cannabis 4.9 (9.4) Sedatives/hypnotics (not barbiturates) 3.8 (7.9) Alcohol 3.0 (6.0) Amphetamine 0.5 (3.3) Cocaine 0.5 (2.0) Barbiturates 0.2 (2.0) Heroin 0.1 (0.6)

37 Other Baseline Substance Use Characteristics Mean years opioid use 5.2 Current cigarette smoker 70.6%

38 Most Frequently Used Opioids in Past 30 Days Oxycodone (sustained) 35% Hydrocodone 32% Oxycodone (immediate) 19% Methadone 6% Other 7%

39 Opioid Use Disorder Treatment Histories Any treatment* 210 (32%) Self-help 124 (59%) Inpatient/residential 88 (42%) Outpatient counseling 84 (40%) Methadone maintenance 64 (31%) Buprenorphine maintenance 46 (22%) Intensive outpatient 33 (16%) Naltrexone 7 (3%) Other medications 11 (5%) *Participants could endorse >1.

40 Percent of patients Percent of patients Maximum Buprenorphine Dose Prescribed Phase 1 Phase % % % 18% 10% 13% 13% % 14% 16% 11% 18% mg 12 mg 16 mg 20 mg 24 mg 32 mg Other mg 12 mg 16 mg 20 mg 24 mg 32 mg Other Dose Prescribed Dose Prescribed

41 Results

42 Study Question 1: Does adding drug counseling to bup-nx + SMM improve outcome?

43 Phase 1 Successful Outcome SMM + ODC (N=653) SMM P Value 6% 7%.36 Phase 1 successful outcome criteria 4 days opioid use per month No positive urine screens for opioids on 2 consecutive weeks No other formal substance abuse treatment No injection of opioids No more than 1 missing urine sample during the 12 weeks Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

44 Phase 2 Successful Outcome (n=360) Week 12 (end of stabilization) SMM + ODC SMM P Value 52% 47%.3 Phase 2 successful outcome criteria Abstinent for 3 of final 4 weeks (including final week) of bup-nx stabilization (urine-confirmed self-report) Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

45 Phase 2: Successful Outcome at End of Taper and at Follow-up SMM + ODC SMM Overall P Value Week 16 (end of taper) 28% 24% 26%.4 Week 24 (8 wks post-taper) 10% 7% 9%.2 Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

46 % Successful outcomes over time SMM SMM+ODC Phase 1 Phase 2 End of bup Phases 1-2 Phase 2 End of taper Phase 2 Post-taper

47 Study Question 2: How does length of bup-nx treatment affect outcomes in patients with prescription opioid dependence?

48 Successful Outcomes at 3 Time Points Success Phase 1 4-week taper + 8 weeks follow-up 7% Phase 2 Week 12 (end of stabilization) 49% Week 24 (8 weeks post-taper) 9% Time Points Phase 2 week 12 vs phase 2 week 24 P Value <.001 Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

49 Percent of Subjects with Positive Urine for Opioids Percent of Subjects with Positive Urine for Opioids Percent of Subjects with Positive Urine for Opioids Percent of Subjects with Positive Urine for Opioids Percent Opioid Positive Urine Over Time 100% 100% 100% 90% 90% 100% 90% 80% 70% 60% 80% 80% 70% 70% 60% 60% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 50% 50% 40% 40% 30% 30% 20% 20% % 10% SMM Weeks EMM Phase 1 0% 0% SMM SMM 50% 40% 30% 20% 10% 0% Weeks Weeks EMM EMM Phase Weeks SMM EMM Phase 2

50 What Predicts Successful Outcome in Patients with Prescription Opioid Dependence Treated with Buprenorphine-Naloxone?

51 Phase 2 Week 12 Outcome Predictors Sex Race Ethnicity Smoking status Success Male 47% Female 52% White 49% Not White 53% Hispanic 72% Not Hispanic 48% Smokers 47% Nonsmokers 56% P Value *.23 *Not tested because of small sample with Spanish origin (5%).

52 Phase 2 Outcome Predictors (cont): Lifetime Heroin Use Heroin use Success P Value Week 12 (end of stabilization) Week 24 (8 weeks posttaper) Yes 37% No 54% Yes 5% No 10% Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):

53 Chronic Pain: Patient Characteristics & Outcomes

54 Chronic pain patients (n=274) Mean (sd) or % Pain severity (0-10) 4.4 (2.2) Pain interference (0-10) 4.2 (2.7) Course Duration Constant 43% Intermittent 55% >1 year 81% 4 years 55%

55 % of pts with successful outcomes Does chronic pain at baseline predict successful outcome? Chronic pain 40 No chronic pain End of bup tx Week 12 Phase 2 8 weeks post-taper Week 24

56 Conclusions Tapering from opioids, whether initially or after a period of substantial improvement, led to nearly universal relapse SMM produced outcomes equal to SMM + drug counseling Outcomes for patients with chronic pain were no different

57 Caveats Weekly SMM involved excellent counseling, and is more intensive than is often provided in the community; we had no low-intensity MM condition A greater contrast, eg, between less intensive SMM and more intensive counseling may have resulted in differences between groups

58 Caveats (cont) It is unclear what length of bup-nx stabilization, if any, could lead to better outcomes after a taper Long-acting injectable naltrexone was not available during the study period Prescription opioid dependence is an evolving epidemic

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