Effects of Commonly Used Medications on Mood and Choice



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:10/13/2018
Start Date:October 2, 2018
End Date:September 2021
Contact:Darian Weaver
Email:MedChoiceStudy@jhmi.edu
Phone:410-550-1927

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

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.

Inclusion Criteria:

- Age 18-65

- Fluent in written and spoken English and is capable of understanding and complying
with the protocol

- Medically healthy

- Non-smoker

- Appropriate dietary/over-the-counter/prescription/illicit drug use history

- Body Mass Index between 18.5 and 30

- Appropriate use of birth control in females e.g., barrier methods, hormonal
contraceptives, Intra Uterine Devices (IUDs)

Exclusion Criteria:

- Known hypersensitivity to administered drugs

- Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal,
pulmonary or metabolic disease for which administration of the study drugs would be
contraindicated

- Current psychiatric or substance use condition that would interfere with study
participation

- Diastolic blood pressure >90 mmHg or a systolic pressure of >140 mmHg

- Use of medications that would interfere with study participation

- Past prescriptions that may affect study participation

- Unwilling or unable to comply with the protocol

- Any other serious disease or condition that might affect life expectancy or make it
difficult to successfully manage the subjects according to the protocol

- Females: Pregnancy, breastfeeding, or plans to become pregnant
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Roland R Griffiths, PhD
Phone: 410-550-1927
?
mi
from
Baltimore, MD
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