Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00580827
First received: December 25, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

This 18-week, randomized, double blind clinical trial provided treatment for 160 cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM maintenance during the first 4 weeks and cocaine use was assessed; participants were then stratified by level of cocaine use and randomly assigned to receive one of the following: placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or disulfiram at 250 mg/day. During induction onto LAAM, participants were administered increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus disulfiram or placebo disulfiram according to their randomized assignments, and were maintained on these agents through week 16. At the end of the study, participants underwent detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who received ongoing supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes included reductions in other illicit drug and alcohol use, as well as improvements in psychosocial functioning.


Condition Intervention
Cocaine-Related Disorder
Opiate Dependence
Drug: Placebo
Drug: Disulfiram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reductions in cocaine use as measured by urine toxicology and self-report [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: September 2003
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo disulfiram
placebo disulfiram (0 mg/day)
Drug: Placebo
Matched placebo.
Experimental: disulfiram 62.5
disulfiram at 62.5 mg/day
Drug: Disulfiram
disulfiram at 62.5 mg/day for 12 weeks.
Experimental: disulfiram 125
disulfiram at 125 mg/day
Drug: Disulfiram
Disulfiram at 125 mg/day for 12 weeks.
Experimental: disulfiram 250
disulfiram at 250 mg/day
Drug: Disulfiram
disulfiram at 250 mg/day for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 18-65 years.
  • Are not currently enrolled in treatment.
  • Participants must demonstrate opioid dependence, as evidenced by documentation of prior opioid agonist maintenance and/or have signs of withdrawal upon administration of naloxone (<0.8 mg, i.m.), and an opioid-positive urine screen.
  • Participants also must be current users of cocaine with self-reported use of > 7 gm during the preceding 12 months, self-reported use of > 1 time/week in at least one month preceding study entry, and cocaine-positive urine screen.
  • Participants must fulfill DSM-IV criteria for opioid and cocaine dependence.

Exclusion Criteria:

  • current diagnosis of other drug or alcohol physical dependence (other than opiates, cocaine or tobacco)
  • significant medical conditions such as abnormal liver function (with laboratory findings greater than three times normal).
  • active hepatitis; hypertension; a current cardiac condition or high risk of cardiovascular disease; seizure disorders; or another significant underlying medical condition which would contraindicate disulfiram or LAAM treatment.
  • meets DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders; exhibiting current suicidality or homicidality; current use of a prescribed psychotropic medication that cannot be discontinued.
  • pregnancy.
  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: NCT00580827

Locations
United States, Connecticut
West Haven VA
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: James Poling, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: James Poling, Ph.D. / Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT00580827     History of Changes
Other Study ID Numbers: R01 DA13441, NIDA R01 DA13441
Study First Received: December 25, 2007
Last Updated: December 25, 2007
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Disulfiram
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014