Atomoxetine Effects in Humans

NCT ID: NCT00607568

Last Updated: 2011-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-09-30

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.

Conditions

Physiological Stress

Keywords

physical stress; psychological stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

atomoxetine 40mg per day

Group Type: EXPERIMENTAL

Atomoxetine

Intervention Type: DRUG

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.

2

second arm is placebo, sugar pill

Group Type: PLACEBO_COMPARATOR

Atomoxetine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Sofuoglu

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Sofuoglu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

K02DA021304

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

MIRECC HIC 0605001441

Identifier Type: -

Identifier Source: org_study_id