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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: Completed Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure.
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 |
What the finished NCT00713583 record still lists
NCT00713583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00713583 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00713583's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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