Behavioral Pharmacology of THC and Beta-Myrcene

Study Overview
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Brief Summary
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This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.

Detailed Description
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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.

Official Title
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Behavioral Pharmacology of THC and Beta-Myrcene

Conditions
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Cannabis Use

Intervention / Treatment
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* Drug: Placebo
* Drug: THC
* Drug: Beta-Myrcene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided written informed consent Be between the ages of 18 and 55 Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission. Have a body mass index (BMI) in the range of 18 to 36 kg/m2 Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg Have no allergies to any of the ingredients used to prepare vapor (delta 9-THC, myrcene). Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score over 75). Exclusion Criteria: Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit; History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures. Use of an OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. Use of a prescription medication (with the exception of birth control prescriptions) within 5 half-lives for that specific drug; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. Cannabis use that is inconsistent with protocol requirements. Clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina). Individuals with anemia or who have donated blood in the prior 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will complete all dose conditions (study arms) in a randomized order
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (ambient air) | Drug: Placebo<br>* Placebo (ambient air)<br>|
| Experimental: Vaporized high THC alone<br>30mg of vaporized pure THC | Drug: THC<br>* Pure THC vapor<br>* Other names: Cannabis;|
| Experimental: Vaporized low THC alone<br>15mg of vaporized pure THC | Drug: THC<br>* Pure THC vapor<br>* Other names: Cannabis;|
| Experimental: Vaporized low beta-myrcene<br>2mg of vaporized beta-myrcene | Drug: Beta-Myrcene<br>* Pure beta-myrcene vapor<br>|
| Experimental: Vaporized high beta-myrcene<br>9mg of vaporized beta-myrcene | Drug: Beta-Myrcene<br>* Pure beta-myrcene vapor<br>|
| Experimental: Vaporized low THC and low beta-myrcene<br>15mg vaporized THC with 2mg vaporized beta-myrcene | Drug: THC<br>* Pure THC vapor<br>* Other names: Cannabis;Drug: Beta-Myrcene<br>* Pure beta-myrcene vapor<br>|
| Experimental: Vaporized low THC and high beta-myrcene<br>15mg vaporized THC with 9mg vaporized beta-myrcene | Drug: THC<br>* Pure THC vapor<br>* Other names: Cannabis;Drug: Beta-Myrcene<br>* Pure beta-myrcene vapor<br>|
| Experimental: Vaporized high THC and low beta-myrcene<br>30mg vaporized THC with 2mg vaporized beta-myrcene | Drug: THC<br>* Pure THC vapor<br>* Other names: Cannabis;Drug: Beta-Myrcene<br>* Pure beta-myrcene vapor<br>|
| Experimental: Vaporized high THC and high beta-myrcene<br>30mg vaporized THC with 9mg vaporized beta-myrcene | Drug: THC<br>* Pure THC vapor<br>* Other names: Cannabis;Drug: Beta-Myrcene<br>* Pure beta-myrcene vapor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |