Behavioral Pharmacology of THC and Beta-Myrcene

NCT05432284 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00329344R01DA043475
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cannabis Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-reported "Tired/Sleepy" as assessed by the Drug Effect Questionnaire (DEQ)

  6 hours

Other Outcomes (5)

• Driving performance as assessed by composite drive score

  .5 hours

• Psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST)

  6 hours

• Working memory performance as assessed by the Paced Auditory Serial Addition Task

  6 hours

Study Arms (9)

Placebo

PLACEBO COMPARATOR

Placebo (ambient air)

Drug: Placebo

Vaporized high THC alone

EXPERIMENTAL

30mg of vaporized pure THC

Drug: THC

Vaporized low THC alone

EXPERIMENTAL

15mg of vaporized pure THC

Drug: THC

Vaporized low beta-myrcene

EXPERIMENTAL

2mg of vaporized beta-myrcene

Drug: Beta-Myrcene

Vaporized high beta-myrcene

EXPERIMENTAL

9mg of vaporized beta-myrcene

Drug: Beta-Myrcene

Vaporized low THC and low beta-myrcene

EXPERIMENTAL

15mg vaporized THC with 2mg vaporized beta-myrcene

Drug: THC; Drug: Beta-Myrcene

Vaporized low THC and high beta-myrcene

EXPERIMENTAL

15mg vaporized THC with 9mg vaporized beta-myrcene

Drug: THC; Drug: Beta-Myrcene

Vaporized high THC and low beta-myrcene

EXPERIMENTAL

30mg vaporized THC with 2mg vaporized beta-myrcene

Drug: THC; Drug: Beta-Myrcene

Vaporized high THC and high beta-myrcene

EXPERIMENTAL

30mg vaporized THC with 9mg vaporized beta-myrcene

Drug: THC; Drug: Beta-Myrcene

Interventions

Placebo DRUG

Placebo (ambient air)

Placebo

THC DRUG

Pure THC vapor

Also known as: Cannabis

Vaporized high THC alone; Vaporized high THC and high beta-myrcene; Vaporized high THC and low beta-myrcene; Vaporized low THC alone; Vaporized low THC and high beta-myrcene; Vaporized low THC and low beta-myrcene

Beta-Myrcene DRUG

Pure beta-myrcene vapor

Vaporized high THC and high beta-myrcene; Vaporized high THC and low beta-myrcene; Vaporized high beta-myrcene; Vaporized low THC and high beta-myrcene; Vaporized low THC and low beta-myrcene; Vaporized low beta-myrcene

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Dronabinol; nabiximols; beta-myrcene

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ryan Vandrey, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Vandrey, PhD

CONTACT

410-550-4036; rvandrey@jhmi.edu

Tory Spindle, PhD

CONTACT

410-550-0529; tspindle@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: placebo controlled, double blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete all dose conditions (study arms) in a randomized order

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)