Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

Study Overview
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Brief Summary
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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
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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)

Official Title
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Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

Conditions
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Addiction

Intervention / Treatment
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* Drug: Atomoxetine
* Drug: Sugar Pill


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atomoxetine<br>Atomoxetine compared to the sugar pill | Drug: Sugar Pill<br>* Sugar pill compared to Atomoxetine 40mg and 80mg.<br>* Other names: placebo;|
| Placebo Comparator: Sugar Pill<br>Sugar pill compared to atomoxetine | Drug: Atomoxetine<br>* Atomoxetine 40mg and 80mg compared to the sugar pill<br>* Other names: Strattera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid Visual Information Processing | 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. | 2 years | 
| Rapid Visual Information Processing: Mean Correct Response Latency | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abstinent cocaine users, cognitive testing