Not yet recruitingNCT05432284Updated Jul 31, 2026

Behavioral Pharmacology of THC and Beta-Myrcene

A Phase 1 interventional study of Placebo and THC in Cannabis Use, sponsored by Johns Hopkins University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the 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 studied

Cannabis Use

In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 32 participants (estimated)

Study arms

Placebo comparator
Placebo
Placebo (ambient air)
Drug: Placebo
Experimental
Vaporized high THC alone
30mg of vaporized pure THC
Drug: THC
Experimental
Vaporized low THC alone
15mg of vaporized pure THC
Drug: THC
Experimental
Vaporized low beta-myrcene
2mg of vaporized beta-myrcene
Drug: Beta-Myrcene
Experimental
Vaporized high beta-myrcene
9mg of vaporized beta-myrcene
Drug: Beta-Myrcene
Experimental
Vaporized low THC and low beta-myrcene
15mg vaporized THC with 2mg vaporized beta-myrcene
Drug: THC · Drug: Beta-Myrcene
Experimental
Vaporized low THC and high beta-myrcene
15mg vaporized THC with 9mg vaporized beta-myrcene
Drug: THC · Drug: Beta-Myrcene
Experimental
Vaporized high THC and low beta-myrcene
30mg vaporized THC with 2mg vaporized beta-myrcene
Drug: THC · Drug: Beta-Myrcene
Experimental
Vaporized high THC and high beta-myrcene
30mg vaporized THC with 9mg vaporized beta-myrcene
Drug: THC · Drug: Beta-Myrcene

Interventions

DrugPlacebo
Placebo (ambient air)
DrugTHC
Pure THC vapor
Also known as: Cannabis
DrugBeta-Myrcene
Pure beta-myrcene vapor

What researchers measure

Primary outcomes

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.
Time frame: 6 hours

Secondary outcomes

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
Time frame: 6 hours

Other outcomes

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
Time frame: .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).
Time frame: 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).
Time frame: 6 hours
Heart rate
Heart rate (beats/minute) will be measured while sitting down using the vitals machine.
Time frame: 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).
Time frame: 3 hours

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05432284
Lead sponsor: Johns Hopkins University
Collaborators: National Institute on Drug Abuse (NIDA)
Responsible party: Sponsor
First posted: Jun 27, 2022
Start date: Jul 2027 (estimated)
Primary completion: Nov 2028 (estimated)
Completion: Nov 2028 (estimated)
Last update: Jul 31, 2026

Study contacts

Ryan Vandrey, PhD

Contact

rvandrey@jhmi.edu

410-550-4036

Tory Spindle, PhD

Contact

tspindle@jhmi.edu

410-550-0529

Ryan Vandrey, PhD

principal investigator · Johns Hopkins University

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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