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Disulfiram for Cocaine Abuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395850
Recruitment Status : Completed
First Posted : November 3, 2006
Results First Posted : November 13, 2013
Last Update Posted : November 13, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Disulfiram Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disulfiram for Cocaine Abuse
Study Start Date : April 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Disulfiram

Arm Intervention/treatment
Placebo Comparator: 1
microcrystalline cellulose
Drug: Disulfiram
Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks

Experimental: 2
disulfiram at 250 mg/day
Drug: Disulfiram
Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks

Experimental: 3
Disulfiram at 375 mg/day
Drug: Disulfiram
Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks

Experimental: 4
Disulfiram at 500 mg/day
Drug: Disulfiram
Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks

Primary Outcome Measures :
  1. Cocaine Use Over Time [ Time Frame: thrice weekly for 12 weeks ]
    Urine toxicology results (dichotomous: positive or negative) for the presence of cocaine/cocaine metabolite during the disulfiram phase of the study. The change in the probability of a cocaine positive urine sample per day was assessed for each dose compared with placebo and slopes for each dose condition were calculated from Repeated Measures Genearlized Linear Models on a Binomial distribution (thus a Repeated Measures Logistic Regression)

Secondary Outcome Measures :
  1. Retention [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395850

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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Alison Oliveto, Ph.D. University of Arkansas
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Responsible Party: University of Arkansas Identifier: NCT00395850    
Other Study ID Numbers: NIDA-13441
5R01DA013441-02 ( U.S. NIH Grant/Contract )
5R01DA013441-03 ( U.S. NIH Grant/Contract )
5R01DA013441-04 ( U.S. NIH Grant/Contract )
5R01DA013441-06 ( U.S. NIH Grant/Contract )
1R01DA013441-01A1 ( U.S. NIH Grant/Contract )
7R01DA013441-05 ( U.S. NIH Grant/Contract )
5R01DA013441-09 ( U.S. NIH Grant/Contract )
5R01DA013441-10 ( U.S. NIH Grant/Contract )
5R01DA013441-08 ( U.S. NIH Grant/Contract )
R01DA013441 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: November 3, 2006    Key Record Dates
Results First Posted: November 13, 2013
Last Update Posted: November 13, 2013
Last Verified: September 2013
Keywords provided by University of Arkansas:
cocaine dependence
clinical trial
methadone maintenance
dopamine beta-hydroxylase
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action