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Disulfiram for Cocaine Abuse

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ClinicalTrials.gov Identifier: NCT00395850
Recruitment Status : Completed
First Posted : November 3, 2006
Results First Posted : November 13, 2013
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE November 2, 2006
First Posted Date  ICMJE November 3, 2006
Results First Submitted Date March 14, 2013
Results First Posted Date November 13, 2013
Last Update Posted Date November 13, 2013
Study Start Date  ICMJE April 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2006)
cocaine use as determined by urine toxicology screens
Change History Complete list of historical versions of study NCT00395850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
Retention [ Time Frame: 14 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2006)
  • 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
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Disulfiram for Cocaine Abuse
Official Title  ICMJE Disulfiram for Cocaine Abuse
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE Drug: Disulfiram
Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks
Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2013)
118
Original Enrollment  ICMJE
 (submitted: November 2, 2006)
160
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00395850
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Alison Oliveto, Ph.D. University of Arkansas
PRS Account University of Arkansas
Verification Date September 2013

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