Back to resultsCognitive Effects of Atomoxetine in Humans: Genetic Moderators
Primary Purpose
Addiction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Sugar Pill
Sponsored by
About this trial
This is an interventional treatment trial for Addiction focused on measuring Abstinent cocaine users, cognitive testing
Eligibility 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).
Sites / Locations
- Department of Veterans Affairs
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atomoxetine
Sugar Pill
Arm Description
Atomoxetine compared to the sugar pill
Sugar pill compared to atomoxetine
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01498549
Brief Title
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
Official Title
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
Abstinent cocaine users, cognitive testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atomoxetine
Arm Type
Active Comparator
Arm Description
Atomoxetine compared to the sugar pill
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Sugar pill compared to atomoxetine
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
Atomoxetine 40mg and 80mg compared to the sugar pill
Intervention Type
Drug
Intervention Name(s)
Sugar Pill
Other Intervention Name(s)
placebo
Intervention Description
Sugar pill compared to Atomoxetine 40mg and 80mg.
Primary Outcome Measure Information:
Title
Rapid Visual Information Processing
Description
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.
Time Frame
2 years
Title
Rapid Visual Information Processing: Mean Correct Response Latency
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Sofuoglu, M.D., Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Veterans Affairs
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators
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