Trial Outcomes & Findings for Individual Differences in Drug Response (NCT NCT03809546)
NCT ID: NCT03809546
Last Updated: 2024-07-03
Results Overview
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Subscale scores range from 0-20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Difference from baseline (time 0 or pre-capsule) to post-capsule (120 min)
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Placebo
dextrose: We are administering dextrose to health volunteers for our placebo group
|
7.5 mg THC
Dronabinol: THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
|
15 mg THC
Dronabinol: THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individual Differences in Drug Response
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
dextrose: We are administering dextrose to health volunteers for our placebo group
|
7.5 mg THC
n=20 Participants
Dronabinol: THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
|
15 mg THC
n=20 Participants
Dronabinol: THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=113 Participants
|
20 Participants
n=163 Participants
|
20 Participants
n=160 Participants
|
60 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=113 Participants
|
20 Participants
n=163 Participants
|
20 Participants
n=160 Participants
|
60 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=113 Participants
|
14 Participants
n=163 Participants
|
14 Participants
n=160 Participants
|
42 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=113 Participants
|
20 participants
n=163 Participants
|
20 participants
n=160 Participants
|
60 participants
n=483 Participants
|
|
High School Education
|
20 Participants
n=113 Participants
|
20 Participants
n=163 Participants
|
20 Participants
n=160 Participants
|
60 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Difference from baseline (time 0 or pre-capsule) to post-capsule (120 min)The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Subscale scores range from 0-20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Outcome measures
| Measure |
Placebo
n=20 Participants
dextrose: We are administering dextrose to health volunteers for our placebo group
|
7.5 mg THC
n=20 Participants
Dronabinol: THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
|
15 mg THC
n=20 Participants
Dronabinol: THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
|
|---|---|---|---|
|
Change From Baseline in Profile of Mood States (POMS)
Tension - Anxiety
|
2.58 units on a scale
Standard Deviation 0.047
|
4.28 units on a scale
Standard Deviation 0.07
|
8.25 units on a scale
Standard Deviation 0.05
|
|
Change From Baseline in Profile of Mood States (POMS)
Depression - Ejection
|
0.7 units on a scale
Standard Deviation 0.005
|
1.2 units on a scale
Standard Deviation 0.02
|
1.04 units on a scale
Standard Deviation 0.004
|
|
Change From Baseline in Profile of Mood States (POMS)
Anger - Hostility
|
1.2 units on a scale
Standard Deviation .01
|
1.5 units on a scale
Standard Deviation .025
|
4.25 units on a scale
Standard Deviation .036
|
|
Change From Baseline in Profile of Mood States (POMS)
Vigor - Activity
|
5.02 units on a scale
Standard Deviation 0.04
|
7.5 units on a scale
Standard Deviation 0.05
|
6.25 units on a scale
Standard Deviation 0.09
|
|
Change From Baseline in Profile of Mood States (POMS)
Fatigue - Inertia
|
2.0 units on a scale
Standard Deviation 0.11
|
3.75 units on a scale
Standard Deviation 0.04
|
7.25 units on a scale
Standard Deviation 0.01
|
|
Change From Baseline in Profile of Mood States (POMS)
Confusion - Bewilderment
|
2.0 units on a scale
Standard Deviation 0.065
|
2.25 units on a scale
Standard Deviation 0.055
|
3.25 units on a scale
Standard Deviation 0.04
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
7.5 mg THC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
15 mg THC
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