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NCT00746785 · ClinicalTrials.gov registry record · Phase 3
A New Pharmacotherapy for Alcohol Dependence: Olanzapine
A Phase 3 study, sponsored by The Mind Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
NCT00746785 is a Phase 3 study that has completed, run by The Mind Research Network. The registered enrollment target is 304 participants.
The verdict
NCT00746785, a Phase 3 study, has completed, sponsored by The Mind Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
Study Summary
Craving for alcohol has been related to loss of control drinking and is a major target of biological and behavioral interventions for alcohol dependence. Our previous research has demonstrated that olanzapine (a dopamine antagonist) attenuates craving for alcohol, that a variant in the gene that expresses D4 receptors influences craving for alcohol, and that olanzapine is particularly effective at reducing craving among individuals with this variant. Pilot data from a recent 12 week trial of olanzapine indicates that olanzapine is well tolerated and that olanzapine reduces drinking, particularly among individuals with the aforementioned genetic variant. The objective of the present application is to examine the effectiveness of olanzapine (5 mg/day), as compared to olanzapine (2.5 mg/day) and a placebo control, in terms of reducing craving and alcohol use behavior among treatment seeking alcoholics. Furthermore, the present application will examine whether the effects of olanzapine on drinking outcomes are mediated by its effects on a specific putative mechanism (i.e., cue-elicited craving for alcohol) and determine whether the DRD4 VNTR polymorphism is a marker for the effectiveness of olanzapine. To that end, 202 alcohol dependent subjects will be randomly assigned to medication group and receive 12 weeks of medication. Subjects will complete follow-up assessments at 3 and 6 months after the end of the treatment. It is expected that olanzapine will significantly reduce cue-elicited craving and alcohol use behavior in a dose dependent fashion over the course of the 12 week trial and follow-up period, as compared to the placebo condition. Furthermore, it is expected that the effects of olanzapine on alcohol use behavior will be mediated by the effect of olanzapine on cue-elicited craving and that the effects of olanzapine on cue-elicited craving and alcohol use behavior will be moderated by the DRD4 VNTR, such that olanzapine will be more effective among individuals
Interventions
- DRUG placebo
- DRUG 2.5 mg Olanzapine
- DRUG 5mg Olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2002-09 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00746785
The ClinicalTrials.gov registry entry for NCT00746785 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Mind Research Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00746785 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00746785 about?
NCT00746785 is a clinical study titled "A New Pharmacotherapy for Alcohol Dependence: Olanzapine". Craving for alcohol has been related to loss of control drinking and is a major target of biological and behavioral interventions for alcohol dependence. Our previous research has demonstrated that olanzapine (a dopamine antagonist) attenuates craving for alcohol, that a variant in the gene that exp...
What is the current status of trial NCT00746785?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2002-09. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00746785?
The interventions under investigation include: placebo (DRUG), 2.5 mg Olanzapine (DRUG), 5mg Olanzapine (DRUG).
Who is sponsoring clinical trial NCT00746785?
This trial is sponsored by The Mind Research Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
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