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Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone
This study has been completed.
First Received: September 20, 2005   Last Updated: May 3, 2007   History of Changes
Sponsor: National Institute on Drug Abuse (NIDA)
Collaborators: Yale University
University of Arkansas
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218608
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Disulfiram for Cocaine Abuse in Methadone- Patients

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Opioid and cocaine use (measured at Week 14) [ Time Frame: 14 wks ]

Secondary Outcome Measures:
  • Reduction in other illicit drug use [ Time Frame: 14 wks ]
  • Psychological symptoms
  • Legal problems
  • Social functioning
  • Medical problems
  • Occupational functioning (measured at Week 14)

Enrollment: 158
Study Start Date: April 2001
Study Completion Date: January 2007
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
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
Yale University
University of Arkansas
Investigators
Principal Investigator: Alison Oliveto, PhD UAMS
  More Information

No publications provided

Study ID Numbers: NIDA-13441-1, R01-13441-1, DPMC
Study First Received: September 20, 2005
Last Updated: May 3, 2007
ClinicalTrials.gov Identifier: NCT00218608     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine Abuse

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

ClinicalTrials.gov processed this record on February 08, 2010