A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol

Stopped early · Phase 1

Conditions studied: Alcohol Craving, Mood Changes

In brief

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.

Key facts

Study ID
NCT01408589
Run by
University of Colorado, Boulder
People needed
86
Starts
2005-06-01
Expected to finish
2007-12-01
Last updated by the study team
2011-08-03

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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