Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Study Overview
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Brief Summary
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The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.

Detailed Description
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Prescription opioid dependence is increasing and creates a significant public health burden, but office-based physicians lack evidence-based guidelines to decide between maintenance or detoxification treatment with buprenorphine/naloxone. The proposed study compares buprenorphine/naloxone maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trail in a heterogeneous population of prescription opioid dependent patients (N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week induction period. Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, buprenorphine/naloxone will continue unchanged for the remainder of the study. In Dtx, the dosage of buprenorphine/naloxone will be tapered to zero over the next 3 weeks, and patients will not receive additional buprenorphine/naloxone for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness compared to Dtx. Relevance to public health: The results of this study will help define the role of maintenance vs. detoxification with buprenorphine/naloxone in the care of prescription opioid dependent patients in primary care.

Official Title
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Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Conditions
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Opiate Dependence

Intervention / Treatment
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* Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)
* Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: opioid dependence Exclusion Criteria: current dependence on alcohol, cocaine, benzodiazepines or sedatives current suicide or homicide risk current psychotic disorder or untreated major depression inability to read or understand English life-threatening or unstable medical problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: 1<br>Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. | Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)<br>* Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.<br>|
| Experimental: 2<br>Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. | Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)<br>* Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illicit Opioid Use | Urinalysis based on scheduled weekly urine screenings during treatment period | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Protectively Transferred | >= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study | 18 weeks | 
| Retention in Treatment | Mean number of days from randomization to last clinical contact | 18 weeks | 
| Reduction in Cocaine Use | As measured by the percent of provided urines positive for cocaine | 18 weeks | 
| Changes in HIV Risk | As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse). There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales. Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status. | Baseline and 18 weeks | 
| Patient Satisfaction | Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction. | 18 weeks | 
| Health Status | Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buprenorphine, Buprenorphine/naloxone, Counseling, Primary care