Sustained Release d-Amphetamine & Buprenorphine on Drug Seeking Behavior in Opioid & Cocaine Dependent Individuals
Condition: Heroin Dependence; Opioid-Related Disorders; Cocaine Abuse or Dependence
MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders; Heroin Dependence
Study type: Observational

Summary: 
      The purpose of this study is to determine whether maintenance on different oral doses of
      sustained release d-amphetamine (SR-AMP) combined with constant-dose sublingual buprenorphine
      (BUP) is safe and well tolerated and decreases self-administration of cocaine alone or
      combined with hydromorphone (HYD). Secondary aims are to determine whether SR-AMP attenuates
      the subjective and physiological effects of cocaine during drug sampling periods prior to
      choice opportunities.
    

Detailed description: 
      Heroin abusers also frequently abuse cocaine, and concurrent use of these drugs is associated
      with more severe drug dependence and associated psychiatric and medical problems, greater
      risk for HIV infection, worse drug abuse treatment outcome, and creates a public health
      burden. New methods and solutions are needed for this problem.

      While human laboratory models exist to study choice of cocaine or opioids individually,
      studies have not examined choice of cocaine alone or cocaine/opioid combinations by heroin
      dependent individuals, nor have there been interventions to reduce such drug use. We recently
      developed a sensitive laboratory-based choice progressive ratio procedure to study
      drug-seeking behavior for opioids. This study will extend this procedure, in the form of drug
      combination vs. money choices, to obtain a novel human laboratory model of cocaine/opioid
      abuse. The purpose of this study is to determine whether maintenance on different doses of
      sustained release d-amphetamine (SR-AMP) combined with constant-dose buprenorphine (BUP) is
      safe and well tolerated and decreases self-administration of cocaine alone or combined with
      HYD. Secondary aims are to determine whether SR-AMP attenuates the subjective and
      physiological effects of cocaine during drug sampling periods prior to choice opportunities.

      One goal of this new study is to develop a human laboratory model of polydrug abuse by
      allowing participants (who abuse both heroin and cocaine) to choose between drug combinations
      or money. The second goal of this study is to develop medication treatments to reduce cocaine
      use by opioid dependent individuals.

      Participants in this observational study will take part in multiple trials in which they have
      the opportunity to choose between drug combinations (cocaine alone or combined with HYD;
      relative to HYD alone and dual placebo) or money. On the morning of each session, prior to
      the choice procedure, participants will receive a sample of the drug dose that can be chosen.
      Participants will be asked to attend to the effects produced by the drug combination because
      they will be able to choose this relative to money in the choice task in the afternoon
      session. During the choice procedure, participants will have 12 opportunities to choose
      either drug or money. Participants will use a computer to earn choices. Respiration rate,
      oxygen saturation, heart rate, and blood pressure will be monitored throughout the study.
      Self-report questionnaires will be completed at different times during the study.
      Participants will be maintained on a constant dose of BUP throughout the study, with a
      minimum 2-week lead before the experiment, and a fixed 3-week detoxification after study
      completion. During the experiment they will be maintained on different doses of SR-AMP and on
      a constant dose of BUP.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Heroin dependent and Cocaine abuse or dependent research volunteers.
      
Keywords: Opioid; Cocaine; Drug Self Administration