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

Phase 1

Terminated

• Conditions: Alcohol Craving; Mood Changes
• Interventions: Drug: Atomoxetine, Strattera

• Registration Number: NCT01408589
• Lead Sponsor: University of Colorado, Boulder

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2011-07-12
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-02
• Last Update Submitted: 2011-08-02
• Study First Posted: 2011-08-03
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Atomoxetine, Strattera	-
Atomoxetine 40 mg	Atomoxetine, Strattera	-
Atomoxetine 60 mg	Atomoxetine, Strattera	-
Atomoxetine 80 mg	Atomoxetine, Strattera	-

Primary Outcome Measures

Name	Time	Method
Alcohol Craving	Day 5 of medication	Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS

Secondary Outcome Measures

Name	Time	Method
Genetic moderation	day 5 of medication	To determine whether two functional SNPs within the COMT and DBH genes moderate the effects of EtOH and or atomoxetine.; COMT Val158Met (G/A), Val \> Met 2-4x plasma activity DBH -1021 C/T, C/C has 3x more plasma activity NET gene variants were also examined

Trial Locations

Locations (1)

GCRC, University of Colorado Boulder; 🇺🇸 Boulder, Colorado, United States