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| ID | Type | Description | Link |
|---|---|---|---|
| 1-340-0216610-65527L | Other Grant/Funding Number | Substance Abuse And Mental Health Administration |
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| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
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This study will evaluate the pharmacokinetic and pharmacodynamic effects of hemp-based Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels of delta-9-tetrahydrocannabinol (THC).
A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product. Thus, overall 100 participants will complete the study (75 active, 25 placebo).
Participants in each stage will complete a three-phase outpatient protocol that will last a total of 17 days. Phase 1 (Day 1) will be an acute laboratory dosing session (approximately 7 hours in duration). Phase 2 (Days 2-10) will be an outpatient dosing period, during which participants will continue to use participants' assigned product twice daily (morning and evening) in participants' own environment. During Phase 2, participants will visit the laboratory for brief study sessions on Days 2, 3, 7, and 10. Phase 3, will consist of a final follow-up visit on Day 17, after a 1-week drug washout. Pharmacokinetic and pharmacodynamic assessments (subjective and cognitive effects) will be assessed during each phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical CBD Product with low level of THC | Experimental | Participants will topically apply a high CBD-product that also contains low levels of THC. |
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| Placebo topical product | Placebo Comparator | Participants will topically apply a placebo product that does not contain cannabinoids. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | CBD will be topically applied |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urine cannabinoids | Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL) | Days 1, 2, 3, 7, 10, and 17 |
| Change in Blood cannabinoids | Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL) | Days 1, 2, 3, 7, 10, and 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral fluid cannabinoids | Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL) | Days 1, 2, 3, 7, 10, and 17 |
| Change in Hair cannabinoids | Concentration of cannabinoids will be measured in hair (unit of measurement: nanograms/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tory Spindle, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product.
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| THC |
| Drug |
THC will be topically applied |
|
| Placebo | Drug | a placebo product (without cannabinoids) will be topically applied |
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| Days 1 and 17 |
| Change in Subjective drug effects as assessed by the Drug Effect Questionnaire | Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect. | Days 1, 2, 3, 7, 10, and 17 |
| Change in Cognitive performance as assessed by the Divided Attention Task | Cognitive performance will be evaluated with the Divided Attention Task. Will be measured as the mean distance (in computer pixels) of the mouse cursor from the central stimulus. | Days 1, 2, 3, 7, 10, and 17 |
| Change in Working memory performance as assessed by the Paced Serial Addition Task | Working memory performance will be evaluated with the Paced Serial Addition Task (scores can range from 0-90) with 90 indicating perfect performance. | Days 1, 2, 3, 7, 10, and 17 |
| Change in Psychomotor performance as assessed by the Digit Symbol Substitution Task | Psychomotor performance will be evaluated with the Digit Symbol Substitution Task. Will be measured as the number of correct trials within 90 seconds. | Days 1, 2, 3, 7, 10, and 17 |