Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Alkermes. The registered enrollment target is 31 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00511836
The ClinicalTrials.gov registry entry for NCT00511836 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00511836 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.