The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00218608
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 31, 2012
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
University of Arkansas

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Opioid-Related Disorders Drug: Disulfiram Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disulfiram for Cocaine Abuse in Methadone- Patients
Study Start Date : April 2001
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: 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 Name: Antabuse


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cocaine use [ Time Frame: 14 wks ]
    Urine toxicology screens were conducted thrice-weekly for 14 weeks.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218608


Locations
Layout table for location information
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205 7911
Sponsors and Collaborators
University of Arkansas
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Alison Oliveto, PhD UAMS
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00218608    
Other Study ID Numbers: NIDA-13441-1
R01-13441-1
DPMC
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012
Keywords provided by University of Arkansas:
Cocaine Abuse
Additional relevant MeSH terms:
Layout table for MeSH terms
Opioid-Related Disorders
Cocaine-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
 Disulfiram
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action