Effects of Commonly Used Medications on Mood and Choice

NCT ID: NCT03652740

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2024-02-01

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 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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.

Methylphenidate

Intervention Type: DRUG

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

Nicotine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Methylphenidate

Intervention Type: DRUG

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

Nicotine

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Methylphenidate

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

Intervention Type: DRUG

Nicotine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dustin C Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA003890

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00165287

Identifier Type: -

Identifier Source: org_study_id