Effects of Commonly Used Medications on Mood and Choice

Johns Hopkins University25 enrolled

Overview

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

Volunteers 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 report to the laboratory to review their food and beverage intake up to three times per week and will provide saliva samples to be analyzed for caffeine content (3 sessions). During Phases 2 and 3, participants will be administered placebo or drug-containing capsules under double-blind conditions. To facilitate blindness to the study drugs being administered, caffeine, nicotine, and methylphenidate are disclosed to participants during consent among a longer list of potential drugs they may receive including other prescription and over-the-counter stimulant, sedative, and antihistamine medications. During Phase 2 (choice phase), participants will choose between caffeine (200 mg/70 kg) and placebo across 10 choice sequences. Each choice sequence consists of two exposure sessions (i.e., one session each of caffeine or placebo, order counterbalanced) and one choice session (i.e., choice between caffeine or placebo) for a total of 30 sessions in Phase 2. Following the choice phase, participants will complete the dose-effect phase (Phase 3) to measure the subjective reinforcing effects of methylphenidate (10, 20, and 40 mg/70 kg) and nicotine (1, 2, 3 and 4 mg/70 kg) under double-blind conditions. Phase 3 will consist of 13 total sessions including one session per drug/dose condition plus placebo (8 sessions), a replication of the four nicotine doses (4 sessions), and a final multiple-choice reinforcement session (1 session). During the multiple-choice reinforcement session, we will reinforce a randomly selected choice (i.e., drug vs. money) made by the participant after previous sessions as a surrogate measure of drug reinforcement. The identification of behavioral and pharmacological markers of vulnerability to the effects of drugs of abuse is important in order to inform future substance use disorder prevention and regulatory efforts.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PlaceboDRUG

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.

MethylphenidateDRUG

Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligeam doses.

NicotineDRUG

Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Participant Subjective Ratings of Drug Liking (Peak Change)

Primary outcome will be peak change in participant ratings of drug liking relative to pre-drug ratings within 4 hours post-administration. Participants rate drug liking on a scale from -4 (dislike very much) to 4 (like very much) where 0 = Neutral or No Effect. This is not a treatment study, and higher or lower ratings of drug liking do not represent better or worse outcomes.

Time frame: up to 4 hours after capsule ingestion.

Secondary Outcomes

Participant Subjective Ratings of Drug Value

Secondary outcome will be subject rating of monetary drug value as assessed post-administration. Participants will rate the subjective value of the drug on a scale from -$30 (i.e., they would prefer to lose $30 rather than take the drug) to $30 (i.e., they would prefer to take today's drug instead of receiving $30). This is not a treatment study, and higher or lower ratings of drug value do not represent better or worse outcomes.

Time frame: Completed by the participant up to 4 hours after capsule ingestion.

Data from ClinicalTrials.gov

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