Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

NCT00580827 | Completed DMC

• 2 other identifiers: 9811010624R01DA013441
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine-Related Disorder; Opiate Dependence

Outcome Measures

Primary Outcomes (1)

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

  14 weeks

Secondary Outcomes (1)

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

  14 weeks

Study Arms (4)

placebo disulfiram

PLACEBO COMPARATOR

placebo disulfiram (0 mg/day)

Drug: Placebo

disulfiram 62.5

EXPERIMENTAL

disulfiram at 62.5 mg/day

Drug: Disulfiram

disulfiram 125

EXPERIMENTAL

disulfiram at 125 mg/day

Drug: Disulfiram

disulfiram 250

EXPERIMENTAL

disulfiram at 250 mg/day

Drug: Disulfiram

Interventions

Placebo DRUG

Matched placebo.

placebo disulfiram

Disulfiram DRUG

disulfiram at 62.5 mg/day for 12 weeks.

disulfiram 62.5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

West Haven VA

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

• Traccis F, Minozzi S, Trogu E, Vacca R, Vecchi S, Pani PP, Agabio R. Disulfiram for the treatment of cocaine dependence. Cochrane Database Syst Rev. 2024 Jan 5;1(1):CD007024. doi: 10.1002/14651858.CD007024.pub3.

  PMID: 38180268 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• James Poling, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 25, 2007
• First Posted: December 27, 2007
• Study Start: September 1, 2003
• Primary Completion: March 1, 2004
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

US (1)