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Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498549
First Posted: December 23, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
December 20, 2011
December 23, 2011
February 8, 2017
June 8, 2017
July 11, 2017
December 2011
July 2013   (Final data collection date for primary outcome measure)
  • 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.
Rapid Visual Information Processing [ Time Frame: 2 years ]
Cognitive Test to determine the speed of Visual information
Complete list of historical versions of study NCT01498549 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
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.

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)

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Addiction
  • Drug: Atomoxetine
    Atomoxetine 40mg and 80mg compared to the sugar pill
    Other Name: Strattera
  • Drug: Sugar Pill
    Sugar pill compared to Atomoxetine 40mg and 80mg.
    Other Name: placebo
  • Active Comparator: Atomoxetine
    Atomoxetine compared to the sugar pill
    Intervention: Drug: Sugar Pill
  • Placebo Comparator: Sugar Pill
    Sugar pill compared to atomoxetine
    Intervention: Drug: Atomoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
July 2013
July 2013   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
21 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01498549
1103008235
Yes
Not Provided
Plan to Share IPD: No
Mehmet Sofuoglu, Yale University
Yale University
Not Provided
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
Yale University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP