Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 113
- Locations
- 2
- Primary Endpoint
- Illicit Opioid Use
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
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.
Intervention: Behavioral: Buprenorphine/naloxone maintenance (Mtn) (Behavioral)
2
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.
Intervention: Behavioral: Buprenorphine/naloxone detoxification (Dtx) (Behavioral)
Outcomes
Primary Outcomes
Illicit Opioid Use
Time Frame: 18 weeks
Urinalysis based on scheduled weekly urine screenings during treatment period
Secondary Outcomes
- Patient Satisfaction(18 weeks)
- Proportion of Patients Protectively Transferred(18 weeks)
- Retention in Treatment(18 weeks)
- Reduction in Cocaine Use(18 weeks)
- Changes in HIV Risk(Baseline and 18 weeks)
- Health Status(18 weeks)