Pharmacogenetics of Disulfiram for Cocaine
Condition: Cocaine Dependence; Opioid Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Previous research has shown that disulfiram, a medication sometimes used for treating
      alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone
      treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases
      levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in
      cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug
      relapse among cocaine and opiate addicts with varying inherited levels of DBH.
    

Detailed description: 
      Dopamine, a type of neurotransmitter, is the brain's "feel good" chemical. The amount of
      dopamine in the body may be an important factor in how cocaine addicts respond to treatment.
      Disulfiram, like cocaine, enhances dopamine activity. Upon taking disulfiram, subsequent
      intake of cocaine may elevate dopamine to excessive levels that produce extreme discomfort.
      DBH is an enzyme that breaks down dopamine. A particular variation in the DBH gene can affect
      the amount of dopamine that is released in the body. Therefore, cocaine addicts with varying
      DBH genes may respond differently to treatment. The purpose of this study is to compare the
      effectiveness of disulfiram in preventing relapse among methadone-maintained individuals
      addicted to both cocaine and opioids who may have different DBH genes.

      This 17-week study will begin with a 2-week methadone stabilization period. Participants will
      then be randomly assigned to receive a daily dose of either 250 mg of disulfiram or placebo
      for 12 weeks, while concurrently receiving methadone treatment. All participants will stop
      receiving study medication at Week 14, at which point they will undergo a 4-week methadone
      detoxification period. Participants will report cocaine and other drug use, as well as any
      cocaine cravings that they experience. Cocaine levels will be monitored throughout the study
      with urine tests. The DBH gene of each participant will be examined to determine its specific
      make-up and any particular variations.
    

Intervention name(s): Disulfiram; Methadone; CBT; Lactose
Intervention type(s): Drug; Drug; Behavioral; Other
Intervention description(s): Disulfiram 250 mg/day by mouth daily during study weeks 2-13. Disulfiram discontinued during study weeks 14-15.; Initial dose 25 mg; increased by 5 mg at each subsequent daily dosing until 60 mg maintenace dose reached.; 1-hour weekly, individual, manual-guided Cognitive Behaviorial Therapy.; Lactose was added to both the active disulfiram and placebo doses so they tasted identical.
Other intervention name(s): Antabuse; Symoron; Dolophine; Amidone; Methadose; Physeptone; Heptadon; Cognitive Behavioral Therapy; lactose suspension
Intervention MeSH terms: Disulfiram; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid Dependence; Substance Related Disorders