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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA003890 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dustin C Lee, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
There is not currently a plan to make individual participant data available to other researchers.
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Twenty five participants were enrolled in the study. Eight of the enrolled participants (4 participants phase-1, 4 participants phase-2) did not meet criteria and were not included in Phase 3. Twenty-one participants started phase 2 Choice sessions; at the conclusion of the sessions 17 participants were identified as caffeine choosers or non-choosers. Seventeen participants received the interventions in a randomized order. Participants receive each drug and each dose for only one session.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietary Monitoring | All participants (within-subject) receive the same drug conditions, but the order in which the participants receive the drug conditions will be randomized. Caffeine choosers, caffeine non-choosers, are identified during screening and will be randomly assigned to one of several different dose sequences. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo during screening , respectively, 7 or more times during Phase 2 (screening). Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions per protocol. |
| FG001 | Caffeine Choice Sessions | Participants will choose between caffeine (200 mg/70 kg) and placebo. |
| FG002 | Caffeine Choosers | All participants (within-subject) receive the same drug conditions, but the order in which the participants receive the drug conditions will be randomized. Caffeine choosers, caffeine non-choosers, are identified during screening and will be randomly assigned to one of several different dose sequences. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions per protocol. |
| FG003 | Caffeine Non-choosers | All participants (within-subject) receive the same drug conditions, but the order in which the participants receive the drug conditions will be randomized. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo during screening , respectively, 7 or more times during Phase 2 (screening). Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions per protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dietary Monitoring (1 Week) |
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| Caffeine Choice Sessions (Weeks 2-8) |
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| Dose Effect (Weeks 9-14) |
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Study Completers
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| ID | Title | Description |
|---|---|---|
| BG000 | Caffeine Choosers | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive them is randomized. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 4 hours after capsule ingestion. |
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At every study session (up to 14 weeks post enrollment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dustin C. Lee | Johns Hopkins School of Medicine | 410-550-4035 | dlee214@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2021 | Aug 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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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.
| Methylphenidate | Drug | Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligeam doses. |
|
| Nicotine | Drug | Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses. |
|
| Completed by the participant up to 4 hours after capsule ingestion. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Placebo |
|
| 10 mg Methylphenidate |
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| 20 mg Methylphenidate |
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| 40mg Methylphenidate |
|
| 1 mg Nicotine |
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| 2 mg Nicotine |
|
| 3 mg Nicotine |
|
| 4 mg Nicotine |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Caffeine Non-choosers |
This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive them is randomized. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Caffeine Non-Chooser | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. 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. Methylphenidate: Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligeam doses. Nicotine: Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Completed by the participant up to 4 hours after capsule ingestion. |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 10 mg Methylphenidate | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. Methylphenidate: Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligram doses. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | 20 mg Methylphenidate | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. Methylphenidate: Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligram doses. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | 40 mg Methylphenidate | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. Methylphenidate: Methylphenidate hydrochloride is administered orally at 10, 20, and 40 milligram doses. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG004 | 1 mg Nicotine | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. Nicotine: Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG005 | 2 mg Nicotine | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. Nicotine: Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG006 | 3 mg Nicotine | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. Nicotine: Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG007 | 4 mg Nicotine | This is a within-subjects crossover design. Participants are identified as caffeine choosers and caffeine non-choosers during screening. Participants in each arm will receive the same interventions, but the order in which the participants will receive the interventions is randomized. Primary outcomes will be compared between caffeine choosers and non-choosers on Phase 3 drug conditions. Caffeine choosers and non-choosers are individuals who choose caffeine or placebo, respectively, 7 or more times during Phase 2. Nicotine: Nicotine is administered orally via capsule at 1, 2, 3 and 4 milligram doses. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D011725 | Pyridines |
| 20 mg Methylphenidate |
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| 40 mg Methylphenidate |
|
| 1 mg Nicotine |
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| 2 mg Nicotine |
|
| 3 mg Nicotine |
|
| 4 mg Nicotine |
|