Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05432284

Behavioral Pharmacology of THC and Beta-Myrcene

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo (ambient air)

THC

Drug

Pure THC vapor

Other names: Cannabis

Beta-Myrcene

Drug

Pure beta-myrcene vapor

Primary outcomes

  1. Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)

    Time frame: 6 hours

    Peak rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect.

Secondary outcomes

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

    Time frame: 6 hours

    Peak rating (0-100) of Tired/Sleepy on the DEQ, with 0 being no effect and 100

Other outcomes

  1. Driving performance as assessed by composite drive score

    Time frame: .5 hours

    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

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

    Time frame: 6 hours

    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).

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

    Time frame: 6 hours

    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).

  4. Heart rate

    Time frame: 6 hours

    Heart rate (beats/minute) will be measured while sitting down using the vitals machine.

  5. Quantitative levels of D-9-THC in blood

    Time frame: 3 hours

    Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Vandrey, PhD

CONTACT

[email protected]

410-550-4036

Tory Spindle, PhD

CONTACT

[email protected]

410-550-0529

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.