Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00218608
First received: September 20, 2005
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Cocaine-Related Disorders
Opioid-Related Disorders
Drug: Disulfiram
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disulfiram for Cocaine Abuse in Methadone- Patients

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Cocaine use [ Time Frame: 14 wks ] [ Designated as safety issue: No ]
    Urine toxicology screens were conducted thrice-weekly for 14 weeks.


Enrollment: 158
Study Start Date: April 2001
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218608

Locations
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
Principal Investigator: Alison Oliveto, PhD UAMS
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00218608     History of Changes
Other Study ID Numbers: NIDA-13441-1, R01-13441-1, DPMC
Study First Received: September 20, 2005
Last Updated: January 26, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Arkansas:
Cocaine Abuse

Additional relevant MeSH terms:
Cocaine-Related Disorders
Disease
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Substance-Related Disorders
Cocaine
Disulfiram
Methadone
Alcohol Deterrents
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Local
Antitussive Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on October 29, 2014