Atomoxetine Effects in Humans

Physiological Stress Clinical Trial

Official title:

Atomoxetine Effects in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607568
• Other study ID #: MIRECC HIC 0605001441
• Secondary ID: K02DA021304DPMC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 23, 2008
• Last updated: December 9, 2011
• Start date: June 2006
• Est. completion date: September 2009

Study information

• Verified date: December 2011
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physiological Stress

Intervention

Drug:
• Atomoxetine
atomoxetine 40mg per day or placebo For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine		one year	Yes