Trial Outcomes & Findings for Effects of Commonly Used Medications on Mood and Choice (NCT NCT03652740)
NCT ID: NCT03652740
Last Updated: 2026-02-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
up to 4 hours after capsule ingestion.
Results posted on
2026-02-02
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Caffeine Choice Sessions
Participants will choose between caffeine (200 mg/70 kg) and placebo.
|
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.
|
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.
|
|---|---|---|---|---|
|
Dietary Monitoring (1 Week)
STARTED
|
25
|
0
|
0
|
0
|
|
Dietary Monitoring (1 Week)
COMPLETED
|
21
|
0
|
0
|
0
|
|
Dietary Monitoring (1 Week)
NOT COMPLETED
|
4
|
0
|
0
|
0
|
|
Caffeine Choice Sessions (Weeks 2-8)
STARTED
|
0
|
21
|
0
|
0
|
|
Caffeine Choice Sessions (Weeks 2-8)
COMPLETED
|
0
|
17
|
0
|
0
|
|
Caffeine Choice Sessions (Weeks 2-8)
NOT COMPLETED
|
0
|
4
|
0
|
0
|
|
Dose Effect (Weeks 9-14)
STARTED
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
Placebo
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
10 mg Methylphenidate
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
20 mg Methylphenidate
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
40mg Methylphenidate
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
1 mg Nicotine
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
2 mg Nicotine
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
3 mg Nicotine
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
4 mg Nicotine
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
COMPLETED
|
0
|
0
|
8
|
9
|
|
Dose Effect (Weeks 9-14)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Caffeine Choice Sessions
Participants will choose between caffeine (200 mg/70 kg) and placebo.
|
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.
|
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.
|
|---|---|---|---|---|
|
Caffeine Choice Sessions (Weeks 2-8)
Lost to Follow-up
|
0
|
3
|
0
|
0
|
|
Caffeine Choice Sessions (Weeks 2-8)
Protocol Violation
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Effects of Commonly Used Medications on Mood and Choice
Baseline characteristics by cohort
| Measure |
Caffeine Choosers
n=8 Participants
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.
|
Caffeine Non-choosers
n=9 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.25 years
STANDARD_DEVIATION 10.02 • n=13 Participants
|
28.22 years
STANDARD_DEVIATION 6.78 • n=15 Participants
|
28.71 years
STANDARD_DEVIATION 8.20 • n=28 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=13 Participants
|
8 Participants
n=15 Participants
|
14 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=13 Participants
|
8 Participants
n=15 Participants
|
16 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=28 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=13 Participants
|
4 Participants
n=15 Participants
|
7 Participants
n=28 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Caffeine Chooser
n=8 Participants
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 interventions, but the order in which the participants receive the interventions is randomized. 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.
|
Caffeine Non-Chooser
n=9 Participants
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.
|
|---|---|---|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
Placebo
|
1.00 score on a scale
Standard Deviation 1.20
|
-0.11 score on a scale
Standard Deviation 0.60
|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
10 mg Methylphenidate
|
0.88 score on a scale
Standard Deviation 1.13
|
0.33 score on a scale
Standard Deviation 1.31
|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
20 mg Methylphenidate
|
1.63 score on a scale
Standard Deviation 1.19
|
-0.50 score on a scale
Standard Deviation 1.51
|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
40 mg Methylphenidate
|
1.88 score on a scale
Standard Deviation 1.73
|
-0.4 score on a scale
Standard Deviation 1.51
|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
1 mg Nicotine
|
0.44 score on a scale
Standard Deviation 0.94
|
-0.11 score on a scale
Standard Deviation 0.65
|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
2 mg Nicotine
|
0.44 score on a scale
Standard Deviation 1.88
|
-0.39 score on a scale
Standard Deviation 1.02
|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
3 mg Nicotine
|
0.81 score on a scale
Standard Deviation 1.76
|
-1 score on a scale
Standard Deviation 1.2
|
|
Participant Subjective Ratings of Drug Liking (Peak Change)
4 mg Nicotine
|
0.5 score on a scale
Standard Deviation 1.86
|
-0.61 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Completed by the participant up to 4 hours after capsule ingestion.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.
Outcome measures
| Measure |
Caffeine Chooser
n=8 Participants
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 interventions, but the order in which the participants receive the interventions is randomized. 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.
|
Caffeine Non-Chooser
n=9 Participants
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.
|
|---|---|---|
|
Participant Subjective Ratings of Drug Value
Placebo
|
0.19 units on a scale
Standard Deviation 0.81
|
0.06 units on a scale
Standard Deviation 1.59
|
|
Participant Subjective Ratings of Drug Value
10 mg Methylphenidate
|
0.41 units on a scale
Standard Deviation 0.81
|
-1.97 units on a scale
Standard Deviation 12.18
|
|
Participant Subjective Ratings of Drug Value
20 mg Methylphenidate
|
0.06 units on a scale
Standard Deviation 3.00
|
-1.14 units on a scale
Standard Deviation 2.27
|
|
Participant Subjective Ratings of Drug Value
40 mg Methylphenidate
|
1.34 units on a scale
Standard Deviation 4.86
|
0.14 units on a scale
Standard Deviation 1.91
|
|
Participant Subjective Ratings of Drug Value
1 mg Nicotine
|
-1.02 units on a scale
Standard Deviation 2.95
|
-0.42 units on a scale
Standard Deviation 1.28
|
|
Participant Subjective Ratings of Drug Value
2 mg Nicotine
|
-2.81 units on a scale
Standard Deviation 8.19
|
-0.90 units on a scale
Standard Deviation 2.06
|
|
Participant Subjective Ratings of Drug Value
3 mg Nicotine
|
-0.70 units on a scale
Standard Deviation 2.35
|
-4.58 units on a scale
Standard Deviation 7.79
|
|
Participant Subjective Ratings of Drug Value
4 mg Nicotine
|
-3.09 units on a scale
Standard Deviation 7.69
|
-3.13 units on a scale
Standard Deviation 4.02
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 mg Methylphenidate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20 mg Methylphenidate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
40 mg Methylphenidate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1 mg Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 mg Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 mg Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 mg Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place