Pharmacogenetics of Disulfiram for Cocaine
Condition: Cocaine Dependence; Opioid Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Intervention: Disulfiram; Methadone; CBT; Lactose
Intervention description: 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.
Intervention MeSH terms: Disulfiram; Methadone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Opioid Dependence; Substance Related Disorders

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV diagnosis criteria for opioid dependence, as determined by documentation
             of prior treatment for addiction; signs of withdrawal; self-reported history of
             dependence for at least 1 year; and a positive urine test for opioids

          -  Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported
             use of cocaine at least once weekly for at least 1 month prior to study entry; a
             positive urine test for cocaine; and a score greater than 3 on the Severity Dependence
             Scale

          -  If female, willing to use contraception throughout the study

        Exclusion criteria:

          -  Meets DSM-IV diagnosis criteria for dependence on any drugs other than opiates,
             cocaine, or tobacco

          -  Current major psychiatric illness, including schizophrenia, bipolar disorder, or other
             psychotic disorder

          -  Current suicidal or homicidal ideation

          -  Current use of a prescribed psychotropic medication that cannot be discontinued

          -  History of or current major medical illness, including major heart, kidney, endocrine,
             or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater
             than normal);

          -  High risk factor for heart disease, seizure disorders, or any illness for which
             disulfiram or methadone treatment would be inadvisable

          -  Currently taking metronidazole or clotrimazole

          -  Pregnant or breastfeeding