Cognitive Effects of Atomoxetine in Humans: Genetic Moderators



Trial Phase


Trial Purpose and Description

Trial Purpose

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.

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. (June 2014)

Participation Guidelines

21 Years - 50 Years

Eligibility Criteria

Inclusion Criteria:

- Male and females, between the ages of 21 and 50;

- No current dependence or abuse of drugs of abuse or alcohol (except and tobacco);

- No current medical problems and normal ECG;

- For women, not pregnant as determined by pregnancy screening nor breast feeding, and
using acceptable birth control methods.

Exclusion Criteria:

- Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;

- History of major medical illnesses; including liver diseases, heart disease, or other
medical conditions that the physician investigator deems contraindicated for the
subject to be in the study;

- Known allergy to Atomoxetine;

- Use of Monoamine Oxidase inhibitor within the last month (clinically Atomoxetine
administration is contraindicated with or within 2 weeks of discontinuation of
Monoamine oxidase inhibitor therapy).
Yale University
December 2011
Last Updated:
June 13, 2014
Study HIC#:
1103008235 ID: NCT01498549