Official Title: “Effects of Atomoxetine Treatment in Humans”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study

Study Primary Completion Date: June 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Placebo
• Drug: Atomoxetine
  • 20mg maximum of d-amphetamine

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 2
  • Second arm is placebo
• Experimental: 1
  • One arm is atomoxetine 40 mg per day

Primary Measures

• Measuring subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers.
  • Time Frame: one year
    Safety Issue?: Yes

Inclusion Criteria:

• Female and males, age 18 to 45 years
• Current history of good health and normal ECG
• For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

• History of heart disease, hypertension, renal or hepatic diseases, glaucoma, hyperthyroidism, or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study
• Current use of psychotropic medication(antidepressants, antipsychotics, or anxiolytics) and/or diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year.
• Current dependence on alcohol or on drugs or treatment for drug or alcohol addiction(amphetamines have greater abuse liability among those with drug addictions) within the past 5 years.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Mehmet Sofuoglu, M.D., Ph.D. Principal Investigator Yale University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00611936

Study ID Number: 0605001441

ClinicalTrials.gov Identifier: NCT00611936

Health Authority: United States: Institutional Review Board