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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
Sponsor:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Addiction Drug: Atomoxetine Drug: Sugar Pill Not Applicable

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
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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