Atomoxetine Effects in Humans

NCT00607568 | Completed Phase 1 DMC

• 3 other identifiers: MIRECC HIC 0605001441K02DA021304DPMC
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physiological Stress

Keywords

physical stress; psychological stress

Outcome Measures

Primary Outcomes (1)

• Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine

  one year

Study Arms (2)

1

EXPERIMENTAL

atomoxetine 40mg per day

Drug: Atomoxetine

2

PLACEBO COMPARATOR

second arm is placebo, sugar pill

Drug: Atomoxetine

Interventions

Atomoxetine 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.

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Stress, Psychological

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 5, 2008
• Study Start: June 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2009
• Last Updated: December 12, 2011

Record last verified: 2011-12