Trial Outcomes & Findings for Age-Related Effects of THC (NCT NCT04294966)
NCT ID: NCT04294966
Last Updated: 2023-11-09
Results Overview
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS consists of 72 mood adjectives rated on a Likert scale from 0 (not at all) to 4 (extremely), divided into 8 subscales: Friendliness, Anxiety, Elation, Anger, Fatigue, Depression, Confusion and Vigor, and two composite scales: Positive Mood (Elation minus Depression) and Arousal (Vigor plus Anxiety minus Confusion plus Fatigue). Scoring of this instrument provides a global score of 0 to 120 or individual domain scores of 0 to 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
24 participants
Primary outcome timeframe
Through Study Completion, an average of 3 weeks (Baseline - time 0 to Time point 9 (Study Completion))
Results posted on
2023-11-09
Participant Flow
Participant milestones
| Measure |
Placebo
Dextrose: 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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age-Related Effects of THC
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Dextrose: Administering dextrose to health volunteers for our placebo group
|
7.5 mg THC
n=8 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.
|
15 mg THC
n=8 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.
|
Total
n=24 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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 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
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Through Study Completion, an average of 3 weeks (Baseline - time 0 to Time point 9 (Study Completion))The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS consists of 72 mood adjectives rated on a Likert scale from 0 (not at all) to 4 (extremely), divided into 8 subscales: Friendliness, Anxiety, Elation, Anger, Fatigue, Depression, Confusion and Vigor, and two composite scales: Positive Mood (Elation minus Depression) and Arousal (Vigor plus Anxiety minus Confusion plus Fatigue). Scoring of this instrument provides a global score of 0 to 120 or individual domain scores of 0 to 20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Outcome measures
| Measure |
Placebo
n=8 Participants
Dextrose: Administering dextrose to health volunteers for our placebo group
|
7.5 mg THC
n=8 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.
|
15 mg THC
n=8 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.
|
|---|---|---|---|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Anxiety Week 1
|
5.75 units on a scale
Standard Deviation 5.12
|
12.46 units on a scale
Standard Deviation 3.56
|
18.55 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Depression Week 1
|
4.08 units on a scale
Standard Deviation 3.60
|
5.05 units on a scale
Standard Deviation 3.66
|
6.25 units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Vigor Week 1
|
13.00 units on a scale
Standard Deviation 6.03
|
8.05 units on a scale
Standard Deviation 2.25
|
8.25 units on a scale
Standard Deviation 4.25
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Fatigue Week 1
|
6.67 units on a scale
Standard Deviation 6.27
|
14.25 units on a scale
Standard Deviation 6.85
|
8.25 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Friendliness Week 1
|
6.42 units on a scale
Standard Deviation 3.82
|
16.25 units on a scale
Standard Deviation 5.58
|
8.25 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Anxiety Week 3
|
5.50 units on a scale
Standard Deviation 4.56
|
14.25 units on a scale
Standard Deviation 5.88
|
19.25 units on a scale
Standard Deviation 5.22
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Depression Week 3
|
3.92 units on a scale
Standard Deviation 6.64
|
5.28 units on a scale
Standard Deviation 1.33
|
8.25 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Vigor Week 3
|
16.83 units on a scale
Standard Deviation 5.92
|
6.87 units on a scale
Standard Deviation 4.25
|
6.22 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Fatigue Week 3
|
6.0 units on a scale
Standard Deviation 4.86
|
8.65 units on a scale
Standard Deviation 2.58
|
6.25 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline in Profile of Mood States (POMS)
POMS Friendliness Week 3
|
9.42 units on a scale
Standard Deviation 5.99
|
8.22 units on a scale
Standard Deviation 2.25
|
11.25 units on a scale
Standard Deviation 2.25
|
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