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Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
Phase 1 trial testing cannabis in Behavioral Pharmacology of Cannabis in 23 participants. Completed in 1 February 2020.
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 23 |
| Start date | 1 May 2018 |
| Primary completion | 11 June 2019 |
| Estimated completion | 1 February 2020 |
| Sites | 1 location across United States |
Johns Hopkins University
Adults 18 to 45, any sex, with Behavioral Pharmacology of Cannabis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quantitation of active drug (THC) in whole blood (ng/ml).
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | 0 | ± 0 |
| Low-Dose Oral Cannabis | 1.78 | ± 1.93 |
| High-Dose Oral Cannabis | 3.06 | ± 2.41 |
| Placebo Vaporized Cannabis | 0 | ± 0 |
| Low-Dose Vaporized Cannabis | 9.19 | ± 10.43 |
| High-Dose Vaporized Cannabis | 37.24 | ± 22.36 |
Quantitation of THC metabolite in blood (ng/ml)
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | 0 | ± 0 |
| Low-Dose Oral Cannabis | 1.7 | ± 1.7 |
| High-Dose Oral Cannabis | 2.5 | ± 1.0 |
| Placebo Vaporized Cannabis | 0 | ± 0 |
| Low-Dose Vaporized Cannabis | 0.72 | ± 1.1 |
| High-Dose Vaporized Cannabis | 1.3 | ± 1.1 |
Quantitation of THC metabolite in blood (ng/ml).
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | 0 | ± 0 |
| Low-Dose Oral Cannabis | 7.7 | ± 4.5 |
| High-Dose Oral Cannabis | 18.4 | ± 9.3 |
| Placebo Vaporized Cannabis | 0 | ± 0 |
| Low-Dose Vaporized Cannabis | 2.2 | ± 2.5 |
| High-Dose Vaporized Cannabis | 5.6 | ± 3.3 |
Peak change from baseline
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | -0.7 | ± 14.9 |
| Low-Dose Oral Cannabis | 3.7 | ± 14.8 |
| High-Dose Oral Cannabis | 12.2 | ± 14.1 |
| Placebo Vaporized Cannabis | -1.8 | ± 11.8 |
| Low-Dose Vaporized Cannabis | 8.7 | ± 16.9 |
| High-Dose Vaporized Cannabis | 20.8 | ± 21.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | 4.5 | ± 12.5 |
| Low-Dose Oral Cannabis | 36.9 | ± 31.8 |
| High-Dose Oral Cannabis | 59.5 | ± 36.6 |
| Placebo Vaporized Cannabis | 5.6 | ± 15.4 |
| Low-Dose Vaporized Cannabis | 58.2 | ± 37.0 |
| High-Dose Vaporized Cannabis | 84.1 | ± 26.2 |
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".
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | -0.1 | ± 6.5 |
| Low-Dose Oral Cannabis | 4.5 | ± 9.3 |
| High-Dose Oral Cannabis | 12.9 | ± 8.2 |
| Placebo Vaporized Cannabis | 1.3 | ± 6.9 |
| Low-Dose Vaporized Cannabis | 4.7 | ± 8.9 |
| High-Dose Vaporized Cannabis | 10.5 | ± 15.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | 1.1 | ± 13.8 |
| Low-Dose Oral Cannabis | 1.0 | ± 16.1 |
| High-Dose Oral Cannabis | 0.5 | ± 15.4 |
| Placebo Vaporized Cannabis | -2.4 | ± 13.5 |
| Low-Dose Vaporized Cannabis | -2.8 | ± 15.3 |
| High-Dose Vaporized Cannabis | -4.8 | ± 15.6 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Cannabis | -2.3 | ± 11.7 |
| Low-Dose Oral Cannabis | -0.9 | ± 14.4 |
| High-Dose Oral Cannabis | -1.1 | ± 15.2 |
| Placebo Vaporized Cannabis | 2.8 | ± 12.7 |
| Low-Dose Vaporized Cannabis | 2.9 | ± 11.2 |
| High-Dose Vaporized Cannabis | 0.2 | ± 14.0 |
This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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