Effects of Commonly Used Medications on Mood and Choice

NCT03652740 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: IRB00165287R01DA003890
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

over-the-counter; prescription medication; subjective effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant Subjective Ratings of Drug Value

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

Study Arms (2)

Caffeine Chooser

EXPERIMENTAL

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; Drug: Methylphenidate; Drug: Nicotine

Caffeine Non-Chooser

ACTIVE COMPARATOR

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; Drug: Methylphenidate; Drug: Nicotine

Interventions

Methylphenidate DRUG

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

Caffeine Chooser; Caffeine Non-Chooser

Nicotine DRUG

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

Caffeine Chooser; Caffeine Non-Chooser

Placebo 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.

Caffeine Chooser; Caffeine Non-Chooser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Methylphenidate; Nicotine

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Solanaceous Alkaloids; Alkaloids; Pyridines

Results Point of Contact

• Title: Dr. Dustin C. Lee
• Organization: Johns Hopkins School of Medicine

dlee214@jhmi.edu

410-550-4035

Study Officials

• Dustin C Lee, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Please note: This is a double-blind study. As part of instructions during the informed consent process, volunteers will be given a list of drugs they may receive rather than informing them only of the specific drugs being administered. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. Researchers will be blind to the drug conditions on any given session because a pharmacy member with no participant interaction will assign the randomized dose sequence and prepare the study drugs.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: October 2, 2018
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)