Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

Addiction Clinical Trial

Official title:

Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498549
• Other study ID #: 1103008235
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: December 15, 2014
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: December 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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).

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

Intervention

Drug:
• Atomoxetine
40mg or 80mg
• Sugar Pill
Once out of the three days

Locations

Country	Name	City	State
United States	Department of Veterans Affairs	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rapid Visual Information Processing	Cognitive Test to determine the speed of Visual information	2 years	No