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Clinical Trials/NCT01408589
NCT01408589
Terminated
Phase 1

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

University of Colorado, Boulder1 site in 1 country86 target enrollmentJune 2005

Overview

Phase
Phase 1
Intervention
Atomoxetine, Strattera
Conditions
Alcohol Craving
Sponsor
University of Colorado, Boulder
Enrollment
86
Locations
1
Primary Endpoint
Alcohol Craving
Status
Terminated
Last Updated
14 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
December 2007
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Sugar Pill

Intervention: Atomoxetine, Strattera

Atomoxetine 40 mg

Intervention: Atomoxetine, Strattera

Atomoxetine 60 mg

Intervention: Atomoxetine, Strattera

Atomoxetine 80 mg

Intervention: Atomoxetine, Strattera

Outcomes

Primary Outcomes

Alcohol Craving

Time Frame: Day 5 of medication

Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS

Secondary Outcomes

  • Genetic moderation(day 5 of medication)

Study Sites (1)

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