Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT01498549
First received: December 20, 2011
Last updated: June 13, 2014
Last verified: June 2014

December 20, 2011
June 13, 2014
December 2011
July 2013   (final data collection date for primary outcome measure)
Rapid Visual Information Processing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Cognitive Test to determine the speed of Visual information
Same as current
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. (June 2014)

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Addiction
  • Drug: Atomoxetine
    40mg or 80mg
  • Drug: Sugar Pill
    Once out of the three days
  • Active Comparator: Atomoxetine
    Intervention: Drug: Sugar Pill
  • Placebo Comparator: Sugar Pill
    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).
Both
21 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01498549
1103008235
Yes
Mehmet Sofuoglu, Yale University
Yale University
Not Provided
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
Yale University
June 2014

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