Atomoxetine Effects in Humans

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00607568
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 10
• Arms: 2
• Duration (Months): 39

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physiological Stress	Drug: Atomoxetine	Phase 1/Phase 2

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.

1. Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.

2. 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.

3. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Atomoxetine Effects in Humans
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 atomoxetine 40mg per day	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.
Placebo Comparator: 2 second arm is placebo, sugar pill	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.

Outcome Measures

Primary Outcome Measures

1. Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
• ClinicalTrials.gov Identifier: NCT00607568
• Other Study ID Numbers: MIRECC HIC 0605001441; K02DA021304; DPMC
• First Posted: Feb 5, 2008
• Last Update Posted: Dec 12, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Mehmet Sofuoglu, Principle Investigator, Yale University: physical stress; psychological stress
• Additional relevant MeSH terms: Atomoxetine Hydrochloride

Study Results

No Results Posted as of Dec 12, 2011