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NCT00511836 · ClinicalTrials.gov registry record · Phase 4
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
A Phase 4 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT00511836: Completed Phase 4 study, sponsored by Alkermes.
NCT00511836 is a Phase 4 study that has completed, run by Alkermes. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00511836, a Phase 4 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal increases in response to alcohol-related cues. In the double-blind portion, subjects received a single administration of study drug (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg.
Primary Outcome
As was standard among fMRI studies conducted at the study site at the time, a change in BOLD signal in the range of 5% to 6% in anterior cingulate as measured using a 3T magnet,is considered highly significant in block-designed experiments.
Interventions
- DRUG Placebo
- DRUG VIVITROL 380 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-10 |
| Phase | Phase 4 |
What the finished NCT00511836 record still lists
NCT00511836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00511836 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00511836 about?
NCT00511836 is a clinical study titled "ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults". This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect w...
What is the current status of trial NCT00511836?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2007-07. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00511836?
The interventions under investigation include: Placebo (DRUG), VIVITROL 380 mg (DRUG).
Who is sponsoring clinical trial NCT00511836?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00511836's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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