Effects of Atomoxetine Treatment in Humans
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Atomoxetine Treatment in Humans|
- Measuring subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
Second arm is placebo
One arm is atomoxetine 40 mg per day
20mg maximum of d-amphetamine
Objective: This pilot study will examine the effects of a norepinephrine reuptake blocker, atomoxetine, on physiological and subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers. The physical stress model will be the cold pressor test (CPT) and the psychological stress will be the paced auditory serial addition task (PASAT).
Our overall hypothesis is that atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine.
2. Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.
3. Methodology: A total of 18 healthy volunteers will participate in this four-week, within-groups, double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After receiving medication or placebo for three days, subjects will have a 6-hour laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and subjective outcome measures will be obtained during the experimental sessions. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
4. Findings: A total of 10 subjects have completed this study. This study has been published.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611936
|Principal Investigator:||Mehmet Sofuoglu, M.D., Ph.D.||Yale University|