Disulfiram for Cocaine Abuse

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-12-31

Brief Summary

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This study examines the influence of dopamine beta-hydroxylase enzyme activity on the clinical efficacy of the novel pharmacotherapy, disulfiram, for treating cocaine dependence in cocaine-dependent patients, some of whom are opioid dependent and maintained on an FDA-approved opioid agonist. Cocaine dependence as well as co-morbid cocaine and opioid-dependence is associated with more public health issues and poorer treatment prognosis when admitted to methadone maintenance. Yet no effective pharmacotherapies have been developed to treat cocaine dependence to date. One novel pharmacotherapy, disulfiram, has shown some promise as a treatment for this disorder in several clinical trials at a dose of 250 mg/day or more (e.g., Carroll et al., 1998, 2004). This 14-week, randomized, double blind clinical trial will provide treatment for up to160 cocaine-dependent individuals, aged 18-65 years. Participants who are opioid dependent will be stabilized on methadone maintenance during the first 2 weeks and baseline cocaine use will be assessed; participants will be stratified by DBH genotype and randomly assigned to receive disulfiram at either 0, 250, 375 or 500 mg/day. During induction onto methadone for opioid dependent individuals, participants are administered increasing doses of methadone on a daily basis until maintenance doses are attained. At the beginning of week 3, participants receive methadone, if relevant, plus disulfiram or placebo disulfiram according to their randomized assignments, and are maintained on study medication(s) through week 14. At the end of the study, participants will undergo detoxification from the opioid agonist, if relevant, and active/placebo medication over a 4- to 6-week period. All participants receive weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who will receive ongoing supervision. Participants undergo a delay discounting session during week 1. The primary outcomes will be retention, reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses, and disulfiram side-effects profile. Secondary outcomes will include reductions in other illicit drug and alcohol use, and improvements in psychosocial functioning. The prognostic relevance of genotype at the DBH locus, DβH activity, etc., on response to disulfiram will be examined.

Detailed Description

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Conditions

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Cocaine Dependence

Keywords

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cocaine dependence disulfiram clinical trial methadone maintenance pharmacogenetics dopamine beta-hydroxylase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks

Interventions

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Disulfiram

Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* current users of cocaine, including having a cocaine-positive urine
* self-reported use of \> 7 gm during the preceding 6 months and \> 1 time/week in at least one month preceding study entry
* meet DSM-IV criteria for cocaine dependence

Exclusion Criteria

* current diagnosis of alcohol dependence
* significant medical conditions such as abnormal liver function
* active hepatitis
* hypertension
* a current cardiac condition or high risk of cardiovascular disease
* seizure disorders
* any another significant underlying medical condition which would contraindicate disulfiram or methadone treatment
* meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders
* exhibiting current suicidality or homicidality
* pregnancy
* current use of a prescribed psychotropic medication (e.g., antidepressants, anxiolytics, antipsychotics, anticonvulsants, etc.) which cannot be discontinued current use of medications such as anticoagulants, isoniazid, metronidazole, clotrimazole, and paraldehyde.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison Oliveto, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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Identifier Type: OTHER

Identifier Source: secondary_id

NIDA-13441

Identifier Type: -

Identifier Source: org_study_id

Disulfiram for Cocaine Abuse

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Disulfiram

2

Disulfiram

3

Disulfiram

4

Disulfiram

Interventions

Disulfiram

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Institute on Drug Abuse (NIDA)

University of Arkansas

Responsible Party

Principal Investigators

Alison Oliveto, Ph.D.

Locations

University of Arkansas for Medical Sciences

Countries

Other Identifiers

5R01DA013441-02

5R01DA013441-03

5R01DA013441-04

5R01DA013441-06

1R01DA013441-01A1

7R01DA013441-05

5R01DA013441-09

5R01DA013441-10

5R01DA013441-08

R01DA013441

DPMC

NIDA-13441