Clinical trial NCT00607568: Atomoxetine Effects in Humans
Official title: Atomoxetine Effects in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Physiological Stress
Keywords: physical stress
psychological stress
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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: Since our last renewal, a total of 16 subjects signed the consent form. Among those, 6 subjects did not return after signing the consent form. An additional 2 subjects were randomized but did not complete the study. One subjects started 3 times was randomized 3 times therefore counted three times in enrollment. Currently still enrolling subjects. (2/7/07)

Have completed this study with 10 subjects, study was published. This study has been entered twice.

Eligibility 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

Primary outcomes:
measure: Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Mehmet Sofuoglu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: