Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Behavioral: Buprenorphine/naloxone maintenance (Mtn); Behavioral: Buprenorphine/naloxone detoxification (Dtx)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Buprenorphine; Buprenorphine/naloxone; Counseling; Primary care