NCT01408589

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

A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol Craving
• Mood Changes

Interventions

Type	Name	Description
DRUG	Atomoxetine, Strattera	Atomoxetine at 0, 40, 60, 80 mg/day was given for 5 days, all subjects took two capsules per day for 5 days; all active dose groups received 40 mg/day for first 3 days and where then dose escalated to dosage group assigned.

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2011-08-03
• Last updated: 2011-08-03

Locations

1 site across 1 country: United States