Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone

NCT ID: NCT00218608

Last Updated: 2012-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2007-01-31

Brief 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.

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo (microcrystalline cellulose) was suspended in the methadone during weeks 3-14.

Group Type: PLACEBO_COMPARATOR

Disulfiram

Intervention Type: DRUG

Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14

Disulfiram at 62.5 mg

Disulfiram at 62.5 mg was suspended in the methadone during weeks 3-14.

Group Type: ACTIVE_COMPARATOR

Disulfiram

Intervention Type: DRUG

Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14

Disulfiram at 125 mg

Disulfiram at 125 mg/day was suspended in methadone during weeks 3-14.

Group Type: ACTIVE_COMPARATOR

Disulfiram

Intervention Type: DRUG

Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14

Disulfiram at 250 mg

Disulfiram at 250 mg/day was suspended in methadone during weeks 3-14.

Group Type: ACTIVE_COMPARATOR

Disulfiram

Intervention Type: DRUG

Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14

Interventions

Disulfiram

Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14

Intervention Type: DRUG

Other Intervention Names

Antabuse

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Oliveto, PhD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

R01-13441-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-13441-1

Identifier Type: -

Identifier Source: org_study_id