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NCT01343628 · ClinicalTrials.gov registry record · Phase 1
A Gene by Medication Interaction to the Acute Effects of Alcohol
A Phase 1 study, sponsored by University of Virginia.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01343628 is a Phase 1 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 43 participants.
The verdict
NCT01343628, a Phase 1 study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
Alcohol dependence, or "alcoholism", affects approximately 14 million Americans. Currently, only three pharmacotherapies (disulfiram, naltrexone, and acamprosate) have been approved for the treatment of alcohol dependence and these medications are, at best, moderately successful. Thus, there is a great need for the examination of other biological systems, which contribute/influence the drug reward/addiction pathways within the brain, such that the discovery of new targets and new pharmacotherapies will be possible. Other biological systems in addition to dopamine, such as serotonin, and norepinephrine (NE) are thought to be important in several aspects of addiction, including reward, craving and depression. This study will examine the effects of a 5 day course of atomoxetine (a selective NE transporter (NET) inhibitor) (80 mg/day; Strattera or placebo) on alcohol-elicited craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact that it targets NET, neither of which has heretofore been examined in the context of alcohol dependence. It is hopeful that this study, of 64 total individuals, will provide the PI with sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and the involvement of specific single nucleotide polymorphisms within the NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term objective of this research is to develop more efficacious treatment interventions for alcohol abuse and dependence.
Interventions
- DRUG Placebo Comparator
- DRUG Active Comparator: Atomoxetine, Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01343628
The ClinicalTrials.gov registry entry for NCT01343628 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT01343628 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01343628 about?
NCT01343628 is a clinical study titled "A Gene by Medication Interaction to the Acute Effects of Alcohol". Alcohol dependence, or "alcoholism", affects approximately 14 million Americans. Currently, only three pharmacotherapies (disulfiram, naltrexone, and acamprosate) have been approved for the treatment of alcohol dependence and these medications are, at best, moderately successful. Thus, there is a gr...
What is the current status of trial NCT01343628?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2008-01. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01343628?
The interventions under investigation include: Placebo Comparator (DRUG), Active Comparator: Atomoxetine, Placebo (DRUG).
Who is sponsoring clinical trial NCT01343628?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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