Cocaine Use Reduction With Buprenorphine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to investigate the safety and effectiveness of buprenorphine in the
      presence of naltrexone for the treatment of cocaine dependence.
    

Detailed description: 
      This project will assess the utility of buprenorphine in the presence of naltrexone as a
      potential medication useful in reducing cocaine use, commencing a research direction of great
      importance to both theoretical and practical addiction medicine. Buprenorphine will be
      provided as sublingual buprenorphine+naloxone tablets (Suboxone®, "BUP"). Naltrexone will be
      provided as extended-release (XR) naltrexone by injection (Vivitrol®, "XR-NTX").

      In this multi-center, double-blind, placebo-controlled trial, participants will randomly
      assigned to one of three medication conditions: 4mg buprenorphine plus naltrexone
      (BUP4+XR-NTX), 16mg buprenorphine plus naltrexone (BUP16+XR-NTX), or placebo plus naltrexone
      (PLB+XR-NTX) for 8 weeks of treatment. Participants will be scheduled for clinic visits three
      times weekly (for a total of 24 visits across the 8-week treatment period) for observed
      medication administration, provision of take-home medication, collection of safety, medical,
      drug use, psychological, and compliance measures. In addition, all participants will be
      scheduled for once-weekly individual Cognitive Behavioral Therapy (CBT) sessions.

      This protocol will explore the effects of these three medication conditions to test
      buprenorphine as a possible treatment for cocaine dependence. This study will advance the
      science, provide dosing information, and characterize the effects of the combination of the
      two medications in this population.
    

Intervention name(s): Buprenorphine + Naltrexone; Placebo + Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.; Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
Other intervention name(s): Suboxone; buprenorphine/naloxone; Vivitrol; extended release injectable naltrexone; Vivitrol; extended release injectable naltrexone
Intervention MeSH terms: Naltrexone; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine-Related disorders; Cocaine; Substance-Related disorders; Opioid abuse; Opioid dependence; abuse; addiction; treatment; buprenorphine; naltrexone; Suboxone; Vivitrol