Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

Status Completed

Clinical Trial Summary

The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.

Clinical Trial Description

This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the between-subject factors. Similar to previous studies, we propose to compare individuals with two copies of the L4 allele to participants with at least one S4 allele because only less than two percent of the general population is homozygous for the S4 allele. Forty cocaine users and 40 healthy controls will participate in 3 test sessions, where they will be assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include physiological, subjective, and cognitive performance measures.

To date this study has 35 completers and currently in data analysis. (December 2014) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Addiction

Clinical Trial Details

NCT number	NCT01498549
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	N/A
Start date	December 2011
Completion date	July 2013

View Details

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