Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone
Condition: Cocaine-Related Disorders; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used
      in several different forms and can be snorted, smoked, or injected to achieve the desired
      effect. Cocaine users are at risk for many health problems, both directly and indirectly
      related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may
      be effective in reducing cocaine use. This study will evaluate the effectiveness of three
      different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent
      individuals maintained on methadone.
    

Detailed description: 
      Despite the harm that cocaine can cause to the body, its abuse is widespread. It is the cause
      of more visits to hospital emergency rooms nationwide than any other illegal drug. Effective
      treatments for cocaine and opiate addictions are essential to the decline of cocaine- and
      opiate-related disorders. Unfortunately, cocaine use remains prevalent among participants in
      many opioid maintenance programs. The addition of other medications to methadone maintenance
      may prove helpful in reducing cocaine use. Disulfiram, a drug used to treat chronic
      alcoholism, causes unpleasant effects when even small amounts of alcohol are consumed. This
      study will evaluate the effectiveness of three different doses of disulfiram in treating
      cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.

      Participants in this double blind study will be randomly assigned to receive either
      disulfiram at one of three dosage levels (62.5, 125, 250 mg/day) or placebo for 14 weeks.
      During the first 2 weeks, doses of methadone plus either disulfiram or placebo will be
      administered until the assigned maintenance dose is achieved. This dosage level will be
      maintained for the duration of the study. Participants will be required to report to the
      study site Monday through Saturday of each week for assessments and to receive medication.
      They will receive a take-home dose of medication for Sunday. In addition, participants will
      receive a weekly session of cognitive-behavioral therapy. Urine samples will be collected
      three times a week to assess drug use. At the end of the study, participants will undergo a
      4- to 6-week detoxification period in which they will gradually discontinue the use of
      methadone and disulfiram. All participants have the option to request transfer to a local
      methadone maintenance program instead of undergoing detoxification.

      Enrollment has been completed and no subjects are active. Data analyses are being conducted
      at this time.
    

Intervention name(s): Disulfiram
Intervention type(s): Drug
Intervention description(s): Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other intervention name(s): Antabuse
Intervention MeSH terms: Disulfiram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine Abuse