Behavioral Pharmacology of THC and Beta-Myrcene

NCT ID: NCT05432284

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-31
• Study Completion Date: 2027-11-30

Brief Summary

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

Detailed 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.

Conditions

Cannabis Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo (ambient air)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (ambient air)

Vaporized high THC alone

30mg of vaporized pure THC

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Pure THC vapor

Vaporized low THC alone

15mg of vaporized pure THC

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Pure THC vapor

Vaporized low beta-myrcene

2mg of vaporized beta-myrcene

Group Type: EXPERIMENTAL

Beta-Myrcene

Intervention Type: DRUG

Pure beta-myrcene vapor

Vaporized high beta-myrcene

9mg of vaporized beta-myrcene

Group Type: EXPERIMENTAL

Beta-Myrcene

Intervention Type: DRUG

Pure beta-myrcene vapor

Vaporized low THC and low beta-myrcene

15mg vaporized THC with 2mg vaporized beta-myrcene

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Pure THC vapor

Beta-Myrcene

Intervention Type: DRUG

Pure beta-myrcene vapor

Vaporized low THC and high beta-myrcene

15mg vaporized THC with 9mg vaporized beta-myrcene

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Pure THC vapor

Beta-Myrcene

Intervention Type: DRUG

Pure beta-myrcene vapor

Vaporized high THC and low beta-myrcene

30mg vaporized THC with 2mg vaporized beta-myrcene

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Pure THC vapor

Beta-Myrcene

Intervention Type: DRUG

Pure beta-myrcene vapor

Vaporized high THC and high beta-myrcene

30mg vaporized THC with 9mg vaporized beta-myrcene

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Pure THC vapor

Beta-Myrcene

Intervention Type: DRUG

Pure beta-myrcene vapor

Interventions

Placebo

Placebo (ambient air)

Intervention Type: DRUG

THC

Pure THC vapor

Intervention Type: DRUG

Beta-Myrcene

Pure beta-myrcene vapor

Intervention Type: DRUG

Other Intervention Names

Cannabis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Vandrey, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Ryan Vandrey, PhD

Role: CONTACT

rvandrey@jhmi.edu

410-550-4036

Tory Spindle, PhD

Role: CONTACT

tspindle@jhmi.edu

410-550-0529

Other Identifiers

R01DA043475

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00329344

Identifier Type: -

Identifier Source: org_study_id