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NCT00395850 · ClinicalTrials.gov registry record · Phase 2
Disulfiram for Cocaine Abuse
A Phase 2 study of Cocaine Dependence, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT00395850 is a Phase 2 study of Cocaine Dependence that has completed, run by University of Arkansas. The registered enrollment target is 118 participants, below the 295-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00395850, a Phase 2 study of Cocaine Dependence, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study 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. T
Conditions Studied
Interventions
- DRUG Disulfiram
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2007-04 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00395850
The ClinicalTrials.gov registry entry for NCT00395850 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 295-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (60% lower). The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cocaine Dependence appearing as the primary indexed condition, and to 1 intervention - of which Disulfiram is the first listed.
NCT00395850 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT00395850 about?
NCT00395850 is a clinical study titled "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...
What is the current status of trial NCT00395850?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2007-04. Estimated completion is 2011-12.
What conditions does trial NCT00395850 study?
This clinical trial studies the following conditions: Cocaine Dependence.
What interventions are being tested in trial NCT00395850?
The interventions under investigation include: Disulfiram (DRUG).
Who is sponsoring clinical trial NCT00395850?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00395850 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.