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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA043475 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC alone, myrcene alone, THC and myrcene together, or placebo. Subjective drug effects and vital signs will be assessed following drug administration. Each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help us understand the individual and interactive effects of THC and b-myrcene, two common constituents found in cannabis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (ambient air) |
|
| Vaporized high THC alone | Experimental | 30mg of vaporized pure THC |
|
| Vaporized low THC alone | Experimental | 15mg of vaporized pure THC |
|
| Vaporized low beta-myrcene | Experimental | 2mg of vaporized beta-myrcene |
|
| Vaporized high beta-myrcene | Experimental | 9mg of vaporized beta-myrcene |
|
| Vaporized low THC and low beta-myrcene | Experimental | 15mg vaporized THC with 2mg vaporized beta-myrcene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo (ambient air) |
| |
| THC |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ) | Peak rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported "Tired/Sleepy" as assessed by the Drug Effect Questionnaire (DEQ) | Peak rating (0-100) of Tired/Sleepy on the DEQ, with 0 being no effect and 100 | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Driving performance as assessed by composite drive score | Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes. There is no upper or lower limit to possible scores | .5 hours |
| Psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Vandrey, PhD | Contact | 410-550-4036 | rvandrey@jhmi.edu | |
| Tory Spindle, PhD | Contact | 410-550-0529 | tspindle@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C587251 | nabiximols |
| C008574 | beta-myrcene |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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All participants will complete all dose conditions (study arms) in a randomized order
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placebo controlled, double blind
| Vaporized low THC and high beta-myrcene | Experimental | 15mg vaporized THC with 9mg vaporized beta-myrcene |
|
| Vaporized high THC and low beta-myrcene | Experimental | 30mg vaporized THC with 2mg vaporized beta-myrcene |
|
| Vaporized high THC and high beta-myrcene | Experimental | 30mg vaporized THC with 9mg vaporized beta-myrcene |
|
| Drug |
Pure THC vapor |
|
|
| Beta-Myrcene | Drug | Pure beta-myrcene vapor |
|
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance). |
| 6 hours |
| Working memory performance as assessed by the Paced Auditory Serial Addition Task | Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance). | 6 hours |
| Heart rate | Heart rate (beats/minute) will be measured while sitting down using the vitals machine. | 6 hours |
| Quantitative levels of D-9-THC in blood | Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml). | 3 hours |