Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Rapid Visual Information Processing
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Atomoxetine
Atomoxetine compared to the sugar pill
Intervention: Sugar Pill (Drug)
Sugar Pill
Sugar pill compared to atomoxetine
Intervention: Atomoxetine (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehmet Sofuoglu
Prinicipal Investigator
Yale University