Behavioral Pharmacology of THC and Beta-Myrcene

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cannabis Use
• Intervention / Treatment: Drug: Placebo; Drug: THC; Drug: Beta-Myrcene

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ryan Vandrey, PhD; Phone Number: 410-550-4036; Email: rvandrey@jhmi.edu
• Study Contact Backup: Name: Tory Spindle, PhD; Phone Number: 410-550-0529; Email: tspindle@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ryan Vandrey, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol; nabiximols; beta-myrcene
• Other Study ID Numbers: IRB00329344; R01DA043475 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No