Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone

January 26, 2012 updated by: University of Arkansas

Disulfiram for Cocaine Abuse in Methadone- Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205 7911
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of cocaine use at least once a week during the month prior to study entry
  • Urine screen tests positive for cocaine
  • Meets DSM-IV criteria for opioid- and cocaine-dependence
  • Urine toxicology screen tests negative for benzodiazepines prior to beginning methadone treatment

Exclusion Criteria:

  • Current drug or alcohol dependence other than opiates, cocaine, or tobacco
  • Significant medical condition, such as abnormal liver function (with laboratory findings greater than three times normal), active hepatitis, or high blood pressure
  • Current cardiac condition
  • Occult coronary artery disease
  • At high risk for cardiovascular disease, seizure disorders, or any other significant underlying medical condition that may make treatment with disulfiram or methadone unsafe
  • Meets DSM-IV psychiatric diagnostic criteria for lifetime schizophrenia, bipolar disorder, or other psychotic disorders
  • Currently suicidal or homicidal
  • Currently taking a prescribed psychotropic medication that cannot be discontinued
  • Pregnant
  • Currently taking metronidazole or clotrimazole

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo (microcrystalline cellulose) was suspended in the methadone during weeks 3-14.
Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Names:
  • Antabuse
Active Comparator: Disulfiram at 62.5 mg
Disulfiram at 62.5 mg was suspended in the methadone during weeks 3-14.
Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Names:
  • Antabuse
Active Comparator: Disulfiram at 125 mg
Disulfiram at 125 mg/day was suspended in methadone during weeks 3-14.
Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Names:
  • Antabuse
Active Comparator: Disulfiram at 250 mg
Disulfiram at 250 mg/day was suspended in methadone during weeks 3-14.
Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Names:
  • Antabuse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cocaine use
Time Frame: 14 wks
Urine toxicology screens were conducted thrice-weekly for 14 weeks.
14 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

Yale University

Investigators

  • Principal Investigator: Alison Oliveto, PhD, UAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-13441-1
  • DPMC (Other Identifier: NIDA)
  • R01-13441-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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