Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

NCT ID: NCT00580827

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo disulfiram

placebo disulfiram (0 mg/day)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo.

disulfiram 62.5

disulfiram at 62.5 mg/day

Group Type: EXPERIMENTAL

Disulfiram

Intervention Type: DRUG

disulfiram at 62.5 mg/day for 12 weeks.

disulfiram 125

disulfiram at 125 mg/day

Group Type: EXPERIMENTAL

Disulfiram

Intervention Type: DRUG

Disulfiram at 125 mg/day for 12 weeks.

disulfiram 250

disulfiram at 250 mg/day

Group Type: EXPERIMENTAL

Disulfiram

Intervention Type: DRUG

disulfiram at 250 mg/day for 12 weeks.

Interventions

Placebo

Matched placebo.

Intervention Type: DRUG

Disulfiram

disulfiram at 62.5 mg/day for 12 weeks.

Intervention Type: DRUG

Disulfiram

Disulfiram at 125 mg/day for 12 weeks.

Intervention Type: DRUG

Disulfiram

disulfiram at 250 mg/day for 12 weeks.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Yale University

Principal Investigators

James Poling, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

West Haven VA

West Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38180268 (View on PubMed)

Other Identifiers

R01DA013441

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9811010624

Identifier Type: -

Identifier Source: org_study_id