Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Alcohol Dependence, sponsored by Medical University of South Carolina.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00920829 record still lists
NCT00920829 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, above the 305-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (17% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00920829's enrollment target sits among peer trials
358 6th of 43 higher than 38 of 43 other Alcohol Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Dependence 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
-
Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)
COMPLETED · Phase 4
-
Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
COMPLETED · Phase 4
-
The Impact of Heavy Alcohol Use on Saliva and Oral Health
RECRUITING
-
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
RECRUITING · Phase 2
-
Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
RECRUITING
-
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04373317 · 358 participants · Phase 4
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
- NCT05684965 · 358 participants · Phase 1
XTX301 in Patients With Advanced Solid Tumors
- NCT05824975 · 358 participants · Phase 1
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
- NCT06480227 · 358 participants · NA
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia