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NCT00654953 · ClinicalTrials.gov registry record · Phase 2
Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans
A Phase 2 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT00654953: Completed Phase 2 study, sponsored by University of Arkansas.
NCT00654953 is a Phase 2 study that has completed, run by University of Arkansas. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00654953, a Phase 2 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertraline alone or combined with gabapentin delays time to relapse relative to placebo in recently abstinent cocaine-dependent volunteers who are also depressed. In addition, whether depressive symptoms or genetic factors influence treatment response to the study medications will be examined. Our hypothesis is that those on combined sertraline-gabapentin will show a longer period of abstinence than those on sertraline alone or placebo.
Primary Outcome
Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine.
Interventions
- DRUG Placebo
- DRUG sertraline
- DRUG gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2006-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00654953 record still lists
NCT00654953 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00654953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00654953 about?
NCT00654953 is a clinical study titled "Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans". To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertraline alone or combined with gabapentin delays time to relapse relative to placebo in recently abstinent cocaine-dep...
What is the current status of trial NCT00654953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2006-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00654953?
The interventions under investigation include: Placebo (DRUG), sertraline (DRUG), gabapentin (DRUG).
Who is sponsoring clinical trial NCT00654953?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00654953's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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