Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

NCT ID: NCT01498549

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-07-31

Brief 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.

Detailed 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. (January 2016)

Conditions

Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Atomoxetine

Atomoxetine compared to the sugar pill

Group Type: ACTIVE_COMPARATOR

Sugar Pill

Intervention Type: DRUG

Sugar pill compared to Atomoxetine 40mg and 80mg.

Sugar Pill

Sugar pill compared to atomoxetine

Group Type: PLACEBO_COMPARATOR

Atomoxetine

Intervention Type: DRUG

Atomoxetine 40mg and 80mg compared to the sugar pill

Interventions

Atomoxetine

Atomoxetine 40mg and 80mg compared to the sugar pill

Intervention Type: DRUG

Sugar Pill

Sugar pill compared to Atomoxetine 40mg and 80mg.

Intervention Type: DRUG

Other Intervention Names

Strattera; placebo

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Sofuoglu

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Sofuoglu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Department of Veterans Affairs

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1103008235

Identifier Type: -

Identifier Source: org_study_id