Clinical trial NCT03652740: Effects of Commonly Used Medications on Mood and Choice
Official title: Effects of Commonly Used Medications on Mood and Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: over-the-counter
prescription medication
subjective effects
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a within-subjects crossover design. 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.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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 35
* 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

Primary outcomes:
measure: Participant subjective ratings of drug liking (peak change)
timeFrame: up to 4 hours after capsule ingestion.
Secondary outcomes:
measure: Participant subjective ratings of drug value
timeFrame: Completed by the participant up to 4 hours after capsule ingestion.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dustin C Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: