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NCT00920829 · ClinicalTrials.gov registry record · Phase 4
Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism
A Phase 4 study of Alcohol Dependence, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 358
- Enrollment target
- 2
- Study locations
NCT00920829 is a Phase 4 study of Alcohol Dependence that has completed, run by Medical University of South Carolina. The registered enrollment target is 358 participants, above the 305-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (17% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT00920829, a Phase 4 study of Alcohol Dependence, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 358 participants
- Enrollment target
- 2
- Study locations
Study Summary
The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic variation and brain response to alcohol cues utilizing a neuroimaging paradigm. This trial has four specific aims. First, this trial will evaluate whether the presence of the OPRM1 Asp40 allele substitution is associated with improved treatment response to naltrexone in treatment-seeking alcoholics. Second, it will evaluate whether there is a difference in the naltrexone dampening of the alcohol cue-induced brain activation dependent on OPRM1 genotype. Third, it will explore whether alcohol cue-induced brain activation dampening by naltrexone might be a mediating factor in the treatment effects of naltrexone, the OPRM1 gene, or their interaction that might be observed in the first aim. Finally, this trial will evaluate the effect of medication compliance, or adverse effects, on the observed medication by genotype treatment response. A secondary aim will measure medication compliance and side effects based on OPRM1 genotype.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naltrexone 50 Mg
Study Locations (2)
South Carolina
- Medical University of South Carolina, Center for Drug and Alcohol Programs - Charleston
- Medical University of South Carolin - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00920829
The ClinicalTrials.gov registry entry for NCT00920829 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 305-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (17% higher). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol Dependence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00920829 reports 2 study locations spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT00920829 about?
NCT00920829 is a clinical study titled "Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism". The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic variation and brain response to alcohol cues utilizing a neuroimaging paradigm. This trial has four specific aims. First, this trial will evaluate whether the presence of the OPRM1 Asp40 allele substitution is...
What is the current status of trial NCT00920829?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 358 participants. The study started on 2009-06. Estimated completion is 2015-12.
What conditions does trial NCT00920829 study?
This clinical trial studies the following conditions: Alcohol Dependence.
What interventions are being tested in trial NCT00920829?
The interventions under investigation include: Placebo (DRUG), Naltrexone 50 Mg (DRUG).
Who is sponsoring clinical trial NCT00920829?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00920829 being conducted?
This trial has 2 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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