Cognitive Effects of Atomoxetine in Humans: Genetic Moderators - Full Text View

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.

Condition	Intervention
Addiction	Drug: Atomoxetine Drug: Sugar Pill


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

Resource links provided by NLM:

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by Mehmet Sofuoglu, Yale University:

Primary Outcome Measures:

Rapid Visual Information Processing [ Time Frame: 2 years ]
Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets.
Rapid Visual Information Processing: Mean Correct Response Latency [ Time Frame: 2 years ]
Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets.


Enrollment:	35
Study Start Date:	December 2011
Study Completion Date:	July 2013
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Atomoxetine Atomoxetine compared to the sugar pill	Drug: Sugar Pill Sugar pill compared to Atomoxetine 40mg and 80mg. Other Name: placebo
Placebo Comparator: Sugar Pill Sugar pill compared to atomoxetine	Drug: Atomoxetine Atomoxetine 40mg and 80mg compared to the sugar pill Other Name: Strattera

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)

Eligibility


Ages Eligible for Study:	21 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498549

Locations


United States, Connecticut
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Yale University

Investigators


Principal Investigator:	Mehmet Sofuoglu, M.D., Ph.D.	Yale University

More Information


Responsible Party:	Mehmet Sofuoglu, Prinicipal Investigator, Yale University
ClinicalTrials.gov Identifier:	NCT01498549 History of Changes
Other Study ID Numbers:	1103008235
Study First Received:	December 20, 2011
Results First Received:	February 8, 2017
Last Updated:	June 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Mehmet Sofuoglu, Yale University:


Abstinent cocaine users cognitive testing

Additional relevant MeSH terms:


Atomoxetine Hydrochloride Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators	Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2017