Trial Outcomes & Findings for Behavioral Pharmacology of THC and Alpha-pinene (NCT NCT04130633)
NCT ID: NCT04130633
Last Updated: 2025-05-22
Results Overview
Mean Peak change from baseline rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
Vaporized Delta-9-tetrahydrocannabinol (THC) With and Without Alpha-Pinene
Participants vaporized THC and pinene in a within-subject crossover design:
1. Placebo
2. High Pinene (15mg)
3. High THC (30mg)
4. High THC (30mg) and Low Pinene (0.5mg)
5. High THC (30mg) and Mid dose Pinene (5mg)
6. High THC (30mg and High Pinene (15mg)
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
Placebo
|
20
|
|
Overall Study
15 mg Alpha-pinene
|
22
|
|
Overall Study
30mg THC
|
20
|
|
Overall Study
30mg THC / 0.5mg Pinene
|
21
|
|
Overall Study
30mg THC / 5mg Pinene
|
20
|
|
Overall Study
30mg THC / 15mg Pinene
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Pharmacology of THC and Alpha-pinene
Baseline characteristics by cohort
| Measure |
Vaporized THC With and Without Pinene
n=19 Participants
All study completers completed the following 6 conditions in a randomized order:
1. Placebo
2. High Pinene (15mg)
3. High THC (30mg)
4. High THC (30mg) and Low Pinene (0.5mg)
5. High THC (30mg) and Mid dose Pinene (5mg)
6. High THC (30mg and High Pinene (15mg)
|
|---|---|
|
Age, Continuous
|
30.57 years
STANDARD_DEVIATION 8.95 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.Population: Represents study completers
Mean Peak change from baseline rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo (5mL distilled water)
Placebo: Placebo vapor (distilled water)
|
Vaporized High Alpha-pinene
n=19 Participants
15mg of vaporized alpha-pinene
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC Alone
n=19 Participants
30mg of vaporized pure THC
THC: Pure THC vapor
|
Vaporized High THC and Low Alpha-pinene
n=19 Participants
30mg vaporized THC with 0.5mg of vaporized alpha-pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and Mid-dose Alpha-pinene
n=19 Participants
30mg vaporized THC with 5.0mg of vaporized alpha-pinene with
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and High Alpha-pinene
n=19 Participants
30mg of vaporized pure THC and 15mg alpha- pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
|
-1.2 score on a scale
Standard Deviation 16.9
|
5.1 score on a scale
Standard Deviation 19.7
|
67.2 score on a scale
Standard Deviation 27.4
|
66.1 score on a scale
Standard Deviation 35.1
|
61.5 score on a scale
Standard Deviation 37.0
|
62.9 score on a scale
Standard Deviation 38.0
|
PRIMARY outcome
Timeframe: 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.Population: Represents study completers
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Mean peak change from baseline total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo (5mL distilled water)
Placebo: Placebo vapor (distilled water)
|
Vaporized High Alpha-pinene
n=19 Participants
15mg of vaporized alpha-pinene
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC Alone
n=19 Participants
30mg of vaporized pure THC
THC: Pure THC vapor
|
Vaporized High THC and Low Alpha-pinene
n=19 Participants
30mg vaporized THC with 0.5mg of vaporized alpha-pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and Mid-dose Alpha-pinene
n=19 Participants
30mg vaporized THC with 5.0mg of vaporized alpha-pinene with
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and High Alpha-pinene
n=19 Participants
30mg of vaporized pure THC and 15mg alpha- pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)
|
1.6 score on a scale
Standard Deviation 10.9
|
-4.2 score on a scale
Standard Deviation 10.4
|
-12.6 score on a scale
Standard Deviation 16.9
|
-11.2 score on a scale
Standard Deviation 13.2
|
-8.2 score on a scale
Standard Deviation 11.9
|
-11.1 score on a scale
Standard Deviation 15.8
|
PRIMARY outcome
Timeframe: 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.Population: Represents study completers
Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo (5mL distilled water)
Placebo: Placebo vapor (distilled water)
|
Vaporized High Alpha-pinene
n=19 Participants
15mg of vaporized alpha-pinene
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC Alone
n=19 Participants
30mg of vaporized pure THC
THC: Pure THC vapor
|
Vaporized High THC and Low Alpha-pinene
n=19 Participants
30mg vaporized THC with 0.5mg of vaporized alpha-pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and Mid-dose Alpha-pinene
n=19 Participants
30mg vaporized THC with 5.0mg of vaporized alpha-pinene with
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and High Alpha-pinene
n=19 Participants
30mg of vaporized pure THC and 15mg alpha- pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
|---|---|---|---|---|---|---|
|
Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)
|
1.8 score on a scale
Standard Deviation 10.3
|
2.5 score on a scale
Standard Deviation 12.6
|
-8.7 score on a scale
Standard Deviation 13.7
|
-5.1 score on a scale
Standard Deviation 14.7
|
-5.7 score on a scale
Standard Deviation 11.8
|
-7.5 score on a scale
Standard Deviation 12.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vaporized High Alpha-pinene
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vaporized High THC Alone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vaporized High THC and Low Alpha-pinene
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vaporized High THC and Mid-dose Alpha-pinene
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vaporized High THC and High Alpha-pinene
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo (5mL distilled water)
Placebo: Placebo vapor (distilled water)
|
Vaporized High Alpha-pinene
n=22 participants at risk
15mg of vaporized alpha-pinene
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC Alone
n=20 participants at risk
30mg of vaporized pure THC
THC: Pure THC vapor
|
Vaporized High THC and Low Alpha-pinene
n=21 participants at risk
30mg vaporized THC with 0.5mg of vaporized alpha-pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and Mid-dose Alpha-pinene
n=20 participants at risk
30mg vaporized THC with 5.0mg of vaporized alpha-pinene with
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
Vaporized High THC and High Alpha-pinene
n=21 participants at risk
30mg of vaporized pure THC and 15mg alpha- pinene
THC: Pure THC vapor
Alpha-Pinene: Pure alpha-pinene vapor
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
10.0%
2/20 • Number of events 2 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
9.5%
2/21 • Number of events 2 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
|
Social circumstances
Anxiety
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
15.0%
3/20 • Number of events 3 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
10.0%
2/20 • Number of events 2 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
|
Vascular disorders
Tachycardia
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
5.0%
1/20 • Number of events 1 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
|
Vascular disorders
Lightheaded
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
5.0%
1/20 • Number of events 1 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
5.0%
1/20 • Number of events 1 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
|
General disorders
Fatigue
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/22 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
5.0%
1/20 • Number of events 1 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/21 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
0.00%
0/20 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
9.5%
2/21 • Number of events 2 • Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
|
Additional Information
C. Austin Zamarripa, PhD
Johns Hopkins University School of Medicine
Phone: 410-550-6969
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place