Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
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ClinicalTrials.gov Identifier: NCT01498549 |
Recruitment Status
:
Completed
First Posted
: December 23, 2011
Results First Posted
: June 8, 2017
Last Update Posted
: July 11, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Addiction | Drug: Atomoxetine Drug: Sugar Pill | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Cognitive Effects of Atomoxetine in Humans: Genetic Moderators |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Atomoxetine
Atomoxetine compared to the sugar pill
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Drug: Sugar Pill
Sugar pill compared to Atomoxetine 40mg and 80mg.
Other Name: placebo
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Placebo Comparator: Sugar Pill
Sugar pill compared to atomoxetine
|
Drug: Atomoxetine
Atomoxetine 40mg and 80mg compared to the sugar pill
Other Name: Strattera
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- 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.

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Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
Sexes Eligible for Study: | 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498549
United States, Connecticut | |
Department of Veterans Affairs | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Mehmet Sofuoglu, M.D., Ph.D. | Yale University |
Responsible Party: | Mehmet Sofuoglu, Prinicipal Investigator, Yale University |
ClinicalTrials.gov Identifier: | NCT01498549 History of Changes |
Other Study ID Numbers: |
1103008235 |
First Posted: | December 23, 2011 Key Record Dates |
Results First Posted: | June 8, 2017 |
Last Update Posted: | July 11, 2017 |
Last Verified: | June 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 |