Effects of Atomoxetine Treatment in Humans

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00611936
First received: January 29, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Stress
Drug: Placebo
Drug: Atomoxetine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Atomoxetine Treatment in Humans

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Measuring subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: June 2006
Study Completion Date: September 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Second arm is placebo
Drug: Placebo
Placebo
Other Name: placebo
Experimental: 1
One arm is atomoxetine 40 mg per day
Drug: Atomoxetine
20mg maximum of d-amphetamine
Other Name: Atomoxetine

Detailed Description:

Objective: 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: A total of 10 subjects have completed this study. This study has been published.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female and males, age 18 to 45 years
  • Current history of good health and normal ECG
  • For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

  • History of heart disease, hypertension, renal or hepatic diseases, glaucoma, hyperthyroidism, or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study
  • Current use of psychotropic medication(antidepressants, antipsychotics, or anxiolytics) and/or diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year.
  • Current dependence on alcohol or on drugs or treatment for drug or alcohol addiction(amphetamines have greater abuse liability among those with drug addictions) within the past 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611936

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00611936     History of Changes
Other Study ID Numbers: 0605001441
Study First Received: January 29, 2008
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Atomoxetine
Stress
d-amphetamine

Additional relevant MeSH terms:
Dextroamphetamine
Atomoxetine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on September 14, 2014