Effects of Atomoxetine Treatment in Humans

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborators: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Amphetamine; Atomoxetine Hydrochloride

Criteria

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.