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| Name | Class |
|---|---|
| Canopy Growth Corporation | INDUSTRY |
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Cannabis and caffeine are two of the most commonly consumed psychoactive substances in the world, with many consumers reporting positive impacts on energy, alertness, and focus. Preliminary evidence has suggested that cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, may mitigate the negative side effects of caffeine (e.g., feeling jittery) without impacting positive or desired effects. CBD also shows potential in reducing undesirable acute effects (e.g., anxiety) of delta-9-tetrahydrocannabinol (THC), the primary intoxicating cannabinoid found in cannabis. Despite these promising findings, little is known about the potential effects of THC, caffeine, and CBD in combination. This double-blind, randomized, placebo-controlled, within-subject crossover study will assess the effects of combinations of THC, CBD, and caffeine (i.e., THC only; THC + caffeine; THC + CBD + caffeine) on subjective energy, arousal, and cognitive performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral placebo | Placebo Comparator | Acute administration of oral placebo three times in study session (Time 0, 60, and 120). |
|
| Oral administration of 2.5 mg THC | Experimental | Acute administration of oral THC (2.5 mg) three times in study session (Time 0, 60, and 120). |
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| Oral administration of 2.5 mg THC + 60 mg caffeine | Experimental | Acute administration of oral THC (2.5 mg) and oral caffeine (60 mg) three times in study session (Time 0, 60, and 120). |
|
| Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD | Experimental | Acute administration of oral THC (2.5 mg), oral caffeine (60 mg), and oral CBD (35 mg) three times in study session (Time 0, 60, and 120). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Placebo | Drug | Placebo will be orally self-administered by study participants. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Driving Performance on the DRiving Under the Influence of Drugs (DRUID®) | Driving Performance as Measured by the DRiving Under the Influence of Drugs (DRUID®) behavioral task. Higher scores = greater impairment. | 0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration |
| Driving Performance on the Driving Simulator | Driving Performance as Measured by a Driving Simulator task | 170-minutes post drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective feelings of energy | Ratings on the Energetic vs. Lethargic item on the Visual Analogue Mood Scale (VAMS) | 0-, 30-, 90-, 150-minutes post drug administration |
| Change in subjective feelings of alertness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Strickland, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine BPRU | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Oral THC |
| Drug |
THC will be orally self-administered by study participants. |
|
| Oral CBD | Drug | CBD will be orally self-administered by study participants. |
|
| Oral Caffeine | Drug | Caffeine will be orally self-administered by study participants. |
|
Ratings on the Alertness vs. Drowsy item on the Visual Analogue Mood Scale (VAMS)
| 0-, 30-, 90-, 150-minutes post drug administration |
| Change in subjective feelings of focus | Ratings on the Attentive vs. Dreamy item on the Visual Analogue Mood Scale (VAMS) | 0-, 30-, 90-, 150-minutes post drug administration |
| Change in subjective feelings of jitteriness | Ratings on the jitteriness item on the Mood Rating Scale (MRS) | 0-, 30-, 90-, 150-minutes post drug administration |
| Change in subjective feelings of anxiety | Ratings on the state version of the State-Trait Anxiety Inventory (STAI-S) | 0-, 30-, 90-, 150-minutes post drug administration |
| D014970 |
| Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |