Trial Outcomes & Findings for Differences in Cannabis Impairment and Its Measurement Due to Route of Administration (NCT NCT03122691)
NCT ID: NCT03122691
Last Updated: 2023-02-21
Results Overview
Quantitation of active drug (THC) in whole blood (ng/ml).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
8 hours
Results posted on
2023-02-21
Participant Flow
This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Participant milestones
| Measure |
Oral Cannabis 0mg, 10mg, 25mg; Vaporized Cannabis 0mg, 5mg, 20mg
Participants ingested and vaporized THC in the above order in a within-subject crossover design
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
Oral 0mg
|
22
|
|
Overall Study
Oral 10mg
|
22
|
|
Overall Study
Oral 25mg
|
21
|
|
Overall Study
Vape 0mg
|
20
|
|
Overall Study
Vape 5mg
|
21
|
|
Overall Study
Vape 20mg
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
Baseline characteristics by cohort
| Measure |
All Evaluable Study Completers
n=20 Participants
Participants received oral (0, 10, 25mg) and vaporized (0mg, 5, 20mg) THC in a randomized within-subject crossover design
|
|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Quantitation of active drug (THC) in whole blood (ng/ml).
Outcome measures
| Measure |
Placebo Oral Cannabis
n=20 Participants
Single acute administration of placebo cannabis baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 10mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 25mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Placebo Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
|---|---|---|---|---|---|---|
|
Tetrahydrocannabinol (THC) Concentration in Blood
|
0 ng/ml
Standard Deviation 0
|
1.78 ng/ml
Standard Deviation 1.93
|
3.06 ng/ml
Standard Deviation 2.41
|
0 ng/ml
Standard Deviation 0
|
9.19 ng/ml
Standard Deviation 10.43
|
37.24 ng/ml
Standard Deviation 22.36
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Quantitation of THC metabolite in blood (ng/ml)
Outcome measures
| Measure |
Placebo Oral Cannabis
n=20 Participants
Single acute administration of placebo cannabis baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 10mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 25mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Placebo Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
|---|---|---|---|---|---|---|
|
11-hydroxy-tetrahydrocannabinol (11-OH-THC)
|
0 ng/mL
Standard Deviation 0
|
1.7 ng/mL
Standard Deviation 1.7
|
2.5 ng/mL
Standard Deviation 1.0
|
0 ng/mL
Standard Deviation 0
|
0.72 ng/mL
Standard Deviation 1.1
|
1.3 ng/mL
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Quantitation of THC metabolite in blood (ng/ml).
Outcome measures
| Measure |
Placebo Oral Cannabis
n=20 Participants
Single acute administration of placebo cannabis baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 10mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 25mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Placebo Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
|---|---|---|---|---|---|---|
|
Tetrahydrocannabinolic Acid (THCCOOH)
|
0 ng/mL
Standard Deviation 0
|
7.7 ng/mL
Standard Deviation 4.5
|
18.4 ng/mL
Standard Deviation 9.3
|
0 ng/mL
Standard Deviation 0
|
2.2 ng/mL
Standard Deviation 2.5
|
5.6 ng/mL
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposurePopulation: This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Peak change from baseline
Outcome measures
| Measure |
Placebo Oral Cannabis
n=20 Participants
Single acute administration of placebo cannabis baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 10mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 25mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Placebo Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
|---|---|---|---|---|---|---|
|
Change in Heart Rate
|
-0.7 Beats per minute
Standard Deviation 14.9
|
3.7 Beats per minute
Standard Deviation 14.8
|
12.2 Beats per minute
Standard Deviation 14.1
|
-1.8 Beats per minute
Standard Deviation 11.8
|
8.7 Beats per minute
Standard Deviation 16.9
|
20.8 Beats per minute
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Up to 5 hoursPopulation: This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Subjective rating of drug effect (0-100) at peak effect: between 2 and 5 hours for oral dosing conditions and 0 and 2 hours for vaporized conditions. Higher numbers mean stronger drug effects, where 0 means no drug effect and 100 means extremely strong drug effect.
Outcome measures
| Measure |
Placebo Oral Cannabis
n=20 Participants
Single acute administration of placebo cannabis baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 10mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 25mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Placebo Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
|---|---|---|---|---|---|---|
|
Mean (SD) Peak Change-from-baseline Drug Effect Rating
|
4.5 Score on a scale
Standard Deviation 12.5
|
36.9 Score on a scale
Standard Deviation 31.8
|
59.5 Score on a scale
Standard Deviation 36.6
|
5.6 Score on a scale
Standard Deviation 15.4
|
58.2 Score on a scale
Standard Deviation 37.0
|
84.1 Score on a scale
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Composite Global Impairment Score on the DRUID (DRiving Under the Influence of Drugs) App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance. ≥13-point change (from baseline) on DRUID global impairment score = "impaired"; \<13-point change (from baseline) = "not impaired".
Outcome measures
| Measure |
Placebo Oral Cannabis
n=20 Participants
Single acute administration of placebo cannabis baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 10mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 25mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Placebo Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
|---|---|---|---|---|---|---|
|
Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score
|
-0.1 score on a scale
Standard Deviation 6.5
|
4.5 score on a scale
Standard Deviation 9.3
|
12.9 score on a scale
Standard Deviation 8.2
|
1.3 score on a scale
Standard Deviation 6.9
|
4.7 score on a scale
Standard Deviation 8.9
|
10.5 score on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 8 hours post drug exposurePopulation: This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.
Systolic and Diastolic blood pressure will be measured at baseline and repeatedly for 8 hours after drug exposure. Outcome is the peak change from baseline assessed within the 8 hour period of assessment.
Outcome measures
| Measure |
Placebo Oral Cannabis
n=20 Participants
Single acute administration of placebo cannabis baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 10mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Oral Cannabis
n=20 Participants
Single acute administration of cannabis containing 25mg THC baked into a brownie
cannabis: Cannabis will be self-administered by study participants
|
Placebo Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
Low-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
High-Dose Vaporized Cannabis
n=20 Participants
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
cannabis: Cannabis will be self-administered by study participants
|
|---|---|---|---|---|---|---|
|
Peak Change in Blood Pressure
Systolic BP
|
1.1 mm/Hg
Standard Deviation 13.8
|
1.0 mm/Hg
Standard Deviation 16.1
|
0.5 mm/Hg
Standard Deviation 15.4
|
-2.4 mm/Hg
Standard Deviation 13.5
|
-2.8 mm/Hg
Standard Deviation 15.3
|
-4.8 mm/Hg
Standard Deviation 15.6
|
|
Peak Change in Blood Pressure
Diastolic BP
|
-2.3 mm/Hg
Standard Deviation 11.7
|
-0.9 mm/Hg
Standard Deviation 14.4
|
-1.1 mm/Hg
Standard Deviation 15.2
|
2.8 mm/Hg
Standard Deviation 12.7
|
2.9 mm/Hg
Standard Deviation 11.2
|
0.2 mm/Hg
Standard Deviation 14.0
|
Adverse Events
Placebo Oral Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-Dose Oral Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-Dose Oral Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Vaporized Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-Dose Vaporized Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-Dose Vaporized Cannabis
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
Dr. Ryan Vandrey
Johns Hopkins University School of Medicine
Phone: 410-550-4036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place