Effects of Commonly Used Medications on Mood and Choice

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Methylphenidate; Drug: Nicotine

Detailed Description

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
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caffeine Chooser; This is a within-subjects crossover design. Participants are not assigned to different groups/arms. All participants receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Primary outcomes will be compared between caffeine choosers and nonchoosers on Phase 3 drug conditions. Caffeine choosers and nonchoosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2.	Drug: Placebo; 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.; Drug: Methylphenidate; Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligeam doses.; Drug: Nicotine; Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses.
Active Comparator: Caffeine Non-Chooser; This is a within-subjects crossover design. Participants are not assigned to different groups/arms. All participants receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Primary outcomes will be compared between caffeine choosers and nonchoosers on Phase 3 drug conditions. Caffeine choosers and nonchoosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2.	Drug: Placebo; 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.; Drug: Methylphenidate; Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligeam doses.; Drug: Nicotine; Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 4 hours after capsule ingestion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Completed by the participant up to 4 hours after capsule ingestion.

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Dustin C Lee, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: subjective effects; over-the-counter; prescription medication
• Additional Relevant MeSH Terms: Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carboxylic Acids; Alkaloids; Piperidines; Acids, Carbocyclic; Phenylacetates; Solanaceous Alkaloids; Methylphenidate; Nicotine
• Other Study ID Numbers: IRB00165287; R01DA003890 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not currently a plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes