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NCT00713583 · ClinicalTrials.gov registry record · Phase 2
Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT00713583 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 85 participants.
The verdict
NCT00713583, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
Cocaine dependence is a major public health problem and the development of a treatment for this disorder is a priority. To date, treatment interventions based on positive incentive principles have shown the strongest effects for improving substance use outcomes. One such example is contingency management (CM) interventions in which nondrug rewards are used to compete with cocaine. Recent evidence suggests that certain medications improve response to CM interventions, particularly agents that target dopamine reward systems in the brain. A promising dopamine-enhancing medication is levodopa. The study team has observed the strongest effects of levodopa when the medication is administered in the context of CM therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is designed to further evaluate this promising treatment approach. Cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. CM will be behavioral therapy platform for both treatment groups. The study will test the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing cocaine use. This study is expected to validate the usefulness of a new behavioral-pharmacological treatment approach for cocaine dependence.
Interventions
- DRUG Placebo
- BEHAVIORAL Contingency Management
- BEHAVIORAL Cognitive Behavioral Therapy
- DRUG levodopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00713583
The ClinicalTrials.gov registry entry for NCT00713583 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00713583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00713583 about?
NCT00713583 is a clinical study titled "Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence". Cocaine dependence is a major public health problem and the development of a treatment for this disorder is a priority. To date, treatment interventions based on positive incentive principles have shown the strongest effects for improving substance use outcomes. One such example is contingency manag...
What is the current status of trial NCT00713583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2008-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00713583?
The interventions under investigation include: Placebo (DRUG), Contingency Management (BEHAVIORAL), Cognitive Behavioral Therapy (BEHAVIORAL), levodopa (DRUG).
Who is sponsoring clinical trial NCT00713583?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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