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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: Clinical Trial Phase 1 study, sponsored by University of Virginia.
NCT01343628 is a Phase 1 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This questionnaire is used to assess craving. The AUQ consists of eight items related to urge drink that are rated on a 7-point Likert scale with the extremes anchored by "Strongly Disagree" and "Strongly Agree." The AUQ has demonstrated internal consistency and reliability (Bohn et al., 1995).
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 |
Why NCT01343628 stopped before completion
NCT01343628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT01343628 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343628's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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