Effects of Commonly Used Medications on Mood and Choice
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This non-treatment study will examine how commonly used prescription or over-the-counter
      medications may influence mood and medication preference.
    

Detailed description: 
      Volunteers (aim is 36 completers) will participate in a double-blind study conducted over a
      period of about 14-17 weeks including sessions for screening, food and beverage diary review
      (Phase 1), drug exposure and choice sessions (Phase 2), and no-choice exposure sessions
      (Phase 3). During Phases 2 and 3, participants will orally ingest capsules containing varying
      doses of commonly prescribed over-the-counter medications and/or placebo. During screening,
      participants will be asked questions about participants' general characteristics including
      demographic information, mood, and personality. Participants will also be examined to
      determine medical eligibility. Eligible participants will proceed to Phase 1 in which
      participants will be asked to eliminate certain foods and beverages from participants diet,
      record participants daily food and beverage consumption and attend the laboratory
      approximately three times per week to discuss participants' food diaries. During Phases 2 and
      3 food and beverage restrictions will remain in place and participants will report to the
      laboratory 2-5 times weekly in order to ingest study capsules and fill out questionnaires
      (e.g., about participants' current mood). After leaving the laboratory, participants will be
      asked to fill out surveys remotely in order to describe the effects of that session's
      capsules on mood and preference.
    

Intervention name(s): Effects of commonly used medications on mood and medication preference
Intervention type(s): Drug
Intervention description(s): Capsules will contain a commonly prescribed or over-the-counter medication, or placebo. A placebo is an inactive substance that looks like the study drug, but contains no active drug. The capsules given in this study may include sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, and antihistamines. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. Participants will not be informed of the specific drugs they will receive during or after the study. Participants will not receive any drug that is not named as a possible study drug in the written informed consent form. All the study drugs to be administered are legally marketed in the United States.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are not assigned to different groups/arms [Note: we indicated 2 arms below because the form does not allow masking in a single arm study - this study involves administration of drug conditions in different dose sequence orders]. All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Participants will be randomly assigned to one of several different dose sequences.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: over-the-counter; prescription medication; subjective effects