Trial Outcomes & Findings for Differential Responses to Drugs and Sweet Tastes (NCT NCT03810703)
NCT ID: NCT03810703
Last Updated: 2023-02-22
Results Overview
Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
93 participants
Primary outcome timeframe
End of study (Baseline - time 0 and approximately 4 weeks later)
Results posted on
2023-02-22
Participant Flow
Participant milestones
| Measure |
Placebo Arm
Participant will receive placebo oral capsule during this four hour session.
Placebo oral capsule: Placebo oral capsule
|
Amphetamine 10 mg Arm
Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule
|
Amphetamine 20 mg Arm
Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Differential Responses to Drugs and Sweet Tastes
Baseline characteristics by cohort
| Measure |
Placebo Arm
n=31 Participants
Participant will receive placebo oral capsule during this four hour session.
Placebo oral capsule: Placebo oral capsule
|
Amphetamine 10 mg Arm
n=31 Participants
Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule
|
Amphetamine 20 mg Arm
n=31 Participants
Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Education - High School Education
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of study (Baseline - time 0 and approximately 4 weeks later)Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Outcome measures
| Measure |
Placebo Arm
n=31 Participants
Participant will receive placebo oral capsule during this four hour session.
Placebo oral capsule: Placebo oral capsule
|
Amphetamine 10 mg Arm
n=31 Participants
Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule
|
Amphetamine 20 mg Arm
n=31 Participants
Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule
|
|---|---|---|---|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
Dislike
|
19.00 score on a scale
Standard Error 5.96
|
27.19 score on a scale
Standard Error 6.47
|
16.25 score on a scale
Standard Error 5.15
|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
Feel
|
18.88 score on a scale
Standard Error 8.84
|
35.25 score on a scale
Standard Error 4.46
|
45.75 score on a scale
Standard Error 8.23
|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
Like
|
37.44 score on a scale
Standard Error 7.64
|
50.69 score on a scale
Standard Error 7.82
|
52.81 score on a scale
Standard Error 8.96
|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
High
|
17.50 score on a scale
Standard Error 5.50
|
24.88 score on a scale
Standard Error 5.48
|
32.69 score on a scale
Standard Error 8.68
|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
More
|
29.19 score on a scale
Standard Error 7.56
|
45.38 score on a scale
Standard Error 7.66
|
52.44 score on a scale
Standard Error 8.40
|
Adverse Events
Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amphetamine 10 mg Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amphetamine 20 mg Arm
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