HealthyPhase 1NCT03652740
Effects of Commonly Used Medications on Mood and Choice
A Phase 1 study testing Methylphenidate and Nicotine in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This non-treatment study will examine how commonly used prescription or over-the-counter medications may influence mood and medication preference. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methylphenidate and Nicotine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 1 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
This non-treatment study will examine how commonly used prescription or over-the-counter medications may influence mood and medication preference.
Read the 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
- Being tested
- Placebo, Methylphenidate, Nicotine
- Keywords
- over-the-counter, prescription medication, subjective effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Methylphenidate; Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 hours after capsule ingestion.
Secondary outcomes (1)
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.
Measured: Completed by the participant up to 4 hours after capsule ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start2 Oct 2018
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dustin C Lee, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652740
- Sponsor's protocol ID
- IRB00165287
- Other IDs
- R01DA003890
- Status last verified
- Jan 2026
- First submitted
- 28 Aug 2018
- Last updated
- 2 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not currently a plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Commonly Used Medications on Mood and Choice
- ClinicalTrials.gov ID
- NCT03652740
- Acronym / sponsor ID
- IRB00165287
- Conditions
- Healthy
- Keywords
- over-the-counter, prescription medication, subjective effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caffeine Chooser | Experimental | Drug: Placebo, Drug: Methylphenidate, Drug: NicotineThis 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. |
| Caffeine Non-Chooser | Active comparator | Drug: Placebo, Drug: Methylphenidate, Drug: NicotineThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboCapsules 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 | Caffeine Chooser, Caffeine Non-Chooser |
| MethylphenidateMethylphenidate hydrochloride is administered orally at 10, 20, and 40 milligeam doses. | Drug | Caffeine Chooser, Caffeine Non-Chooser |
| NicotineNicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses. | Drug | Caffeine Chooser, Caffeine Non-Chooser |
Primary outcome
Participant Subjective Ratings of Drug Liking (Peak Change)
Time frame: up to 4 hours after capsule ingestion.
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.
1 secondary outcome
Participant Subjective Ratings of Drug Value
Time frame: Completed by the participant up to 4 hours after capsule ingestion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not currently a plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dustin C Lee, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylphenidate and Nicotine in people with Healthy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Subjective Ratings of Drug Liking (Peak Change) (time frame: up to 4 hours after capsule ingestion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.