Atomoxetine Effects in Humans
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|---|
|
Physiological Stress |
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: | Atomoxetine Effects in Humans |
- Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine [ 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 |
|---|---|
|
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. |
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Mehmet Sofuoglu, Principle Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT00607568 History of Changes |
| Other Study ID Numbers: | MIRECC HIC 0605001441, K02DA021304, DPMC |
| Study First Received: | January 23, 2008 |
| Last Updated: | December 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
physical stress psychological stress |
Additional relevant MeSH terms:
|
Atomoxetine Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013