Overview

Atomoxetine Effects 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
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Atomoxetine Hydrochloride
Criteria
Inclusion Criteria:

- Female and males age 18 yrs to 45 yrs

- Current history of good health and normal ECG

- not pregnant , nor breast feeding

- using acceptable birth control methods

Exclusion Criteria:

- History of heart disease, hypertension, renal or hepatic diseases,
glaucoma,hyperthyroidism,

- Current use of psychotropic medication

- Current dependence on alcohol or on drugs or treatments for drug or alcohol addiction
within the past 5 years