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Disulfiram for Cocaine Abuse

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00395850
First received: November 2, 2006
Last updated: September 6, 2013
Last verified: September 2013

November 2, 2006
September 6, 2013
April 2007
December 2011   (final data collection date for primary outcome measure)
Cocaine Use Over Time [ Time Frame: thrice weekly for 12 weeks ] [ Designated as safety issue: No ]
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)
cocaine use as determined by urine toxicology screens
Complete list of historical versions of study NCT00395850 on ClinicalTrials.gov Archive Site
Retention [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • retention
  • disulfiram side-effects profile
  • reductions in self-reported cocaine and other drug or alcohol use
  • other illicit drug use as assessed by urine toxicology screens
  • improvements in mood and psychosocial functioning
  • genotype at the DBH locus
  • DβH enzyme activity
Not Provided
Not Provided
 
Disulfiram for Cocaine Abuse
Disulfiram for Cocaine Abuse

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Dependence
Drug: Disulfiram
Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks
  • Placebo Comparator: 1
    microcrystalline cellulose
    Intervention: Drug: Disulfiram
  • Experimental: 2
    disulfiram at 250 mg/day
    Intervention: Drug: Disulfiram
  • Experimental: 3
    Disulfiram at 375 mg/day
    Intervention: Drug: Disulfiram
  • Experimental: 4
    Disulfiram at 500 mg/day
    Intervention: Drug: Disulfiram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00395850
NIDA-13441, 5R01DA013441-02, 5R01DA013441-03, 5R01DA013441-04, 5R01DA013441-06, 1R01DA013441-01A1, 7R01DA013441-05, 5R01DA013441-09, 5R01DA013441-10, 5R01DA013441-08, R01DA013441, DPMC
Yes
University of Arkansas
University of Arkansas
National Institute on Drug Abuse (NIDA)
Principal Investigator: Alison Oliveto, Ph.D. University of Arkansas
University of Arkansas
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP