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OpenTrials
Completed

NCT Number: NCT00580827

Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

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.

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Key information

Conditions

Cocaine-related Disorder Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Narcotic-Related Disorders Opiate Dependence Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Haven VA

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Matched placebo.

Disulfiram

Drug

disulfiram at 62.5 mg/day for 12 weeks.

Primary outcomes

  1. Reductions in cocaine use as measured by urine toxicology and self-report

    Time frame: 14 weeks

Secondary outcomes

  1. Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested.

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2003
Primary completion
2004
First posted
Dec 27, 2007
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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