Atomoxetine Effects in Humans
Condition: Physiological Stress
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): 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 MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: physical stress; psychological stress