Behavioral Pharmacology of THC and Beta-Myrcene

Johns Hopkins University

Status and phase: Begins enrollment in 2 months; Phase 1

Conditions: Cannabis Use

Treatments: Drug: Beta-Myrcene; Drug: Placebo; Drug: THC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05432284

R01DA043475 (U.S. NIH Grant/Contract)

IRB00329344

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Have provided written informed consent
2. Be between the ages of 18 and 55
3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
4. Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
5. 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.
6. Have a body mass index (BMI) in the range of 18 to 36 kg/m2
7. 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
8. Have no allergies to any of the ingredients used to prepare vapor (delta 9-THC, myrcene).
9. Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score over 75).

Exclusion criteria

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
2. 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.
3. 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.
4. 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.
5. Cannabis use that is inconsistent with protocol requirements.
6. Clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
7. Individuals with anemia or who have donated blood in the prior 30 days

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (ambient air)

Treatment:

Drug: Placebo

Vaporized high THC alone

Experimental group

Description:

30mg of vaporized pure THC

Treatment:

Drug: THC

Vaporized low THC alone

Experimental group

Description:

15mg of vaporized pure THC

Treatment:

Drug: THC

Vaporized low beta-myrcene

Experimental group

Description:

2mg of vaporized beta-myrcene

Treatment:

Drug: Beta-Myrcene

Vaporized high beta-myrcene

Experimental group

Description:

9mg of vaporized beta-myrcene

Treatment:

Drug: Beta-Myrcene

Vaporized low THC and low beta-myrcene

Experimental group

Description:

15mg vaporized THC with 2mg vaporized beta-myrcene

Treatment:

Drug: THC

Drug: Beta-Myrcene

Vaporized low THC and high beta-myrcene

Experimental group

Description:

15mg vaporized THC with 9mg vaporized beta-myrcene

Treatment:

Drug: THC

Drug: Beta-Myrcene

Vaporized high THC and low beta-myrcene

Experimental group

Description:

30mg vaporized THC with 2mg vaporized beta-myrcene

Treatment:

Drug: THC

Drug: Beta-Myrcene

Vaporized high THC and high beta-myrcene

Experimental group

Description:

30mg vaporized THC with 9mg vaporized beta-myrcene

Treatment:

Drug: THC

Drug: Beta-Myrcene