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NCT01408589 · ClinicalTrials.gov registry record · Phase 1
A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol
A Phase 1 study, sponsored by University of Colorado, Boulder.
- Terminated
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT01408589: Clinical Trial Phase 1 study, sponsored by University of Colorado, Boulder.
NCT01408589 is a Phase 1 study that was terminated before completion, run by University of Colorado, Boulder. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408589, a Phase 1 study, was terminated before completion, sponsored by University of Colorado, Boulder.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40, 60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) 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 pilot study, of 86 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. Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who receive a placebo. Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication) than subjects who receive a placebo.
Primary Outcome
Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS
Interventions
- DRUG Atomoxetine, Strattera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
Why NCT01408589 stopped before completion
NCT01408589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 1 intervention - of which Atomoxetine, Strattera is the first listed.
NCT01408589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01408589 about?
NCT01408589 is a clinical study titled "A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol". This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40, 60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact that it targets ...
What is the current status of trial NCT01408589?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2005-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT01408589?
The interventions under investigation include: Atomoxetine, Strattera (DRUG).
Who is sponsoring clinical trial NCT01408589?
This trial is sponsored by University of Colorado, Boulder, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01408589's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 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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