Prescription Opioid Addiction Treatment Study (POATS)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.

Detailed Description
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This is a randomized 2-phase, open-label; multi-center study conducted in outpatient treatment settings. The main objective of this study is to identify an effective sublingual buprenorphine/naloxone treatment regimen for subjects dependent on prescription opioids. Phase 1 of this study will assess the prevailing one-month detoxification practice. This phase will assess the benefits of individual drug counseling in a short-term treatment paradigm. The second phase of this study will assess the benefit of individual drug counseling in a longer-term treatment paradigm for participants who did not respond successfully to the short-term buprenorphine/naloxone treatment. There is also a long-term follow-up assessment to determine outcomes at 1.5 years, 2.5 years, and 3.5 years after treatment.

Official Title
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A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence

Conditions
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Opiate Dependence, Substance-related Disorders, Opioid-related Disorders

Intervention / Treatment
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* Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse
* Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Physically dependent on opioids Meet DSM-IV criteria for opioid dependence Exclusion Criteria: Known allergy or sensitivity to buprenorphine or naloxone Unstable psychiatric disorder Pregnant or lactating females Liver function test results greater than 5 times the upper limit of normal range

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine/Nx with EMM<br> | Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse<br>* Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.<br>|
| Active Comparator: Buprenorphine/Nx with SMM<br> | Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse<br>* Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 | In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks. | 12 weeks | 
| The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment | In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence. | 12 weeks in Phase 2 period (i.e., 24 weeks into the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up | A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks. | 24 weeks in Phase 2 period (i.e., 36 weeks into the study) | 
| The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition | As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months. | 12 weeks | 
| The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition | As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months. | 12 weeks | 
| The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1 | As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome. | 12 weeks | 
| The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2 | As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opiate Analgesic Dependence