Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

Opiate Dependence Clinical Trial

Official title:

Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580827
• Other study ID #: 9811010624
• Secondary ID: R01DA013441
• Status: Completed
• Phase: N/A
• Start date: September 2003

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine-Related Disorder
• Cocaine-Related Disorders
• Opiate Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Placebo
Matched placebo.
• Disulfiram
disulfiram at 62.5 mg/day for 12 weeks.
• Disulfiram
Disulfiram at 125 mg/day for 12 weeks.
• Disulfiram
disulfiram at 250 mg/day for 12 weeks.

Locations

Country	Name	City	State
United States	West Haven VA	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in cocaine use as measured by urine toxicology and self-report		14 weeks
Secondary	Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested.		14 weeks