Cannabis UsePhase 1NCT05432284
Behavioral Pharmacology of THC and Beta-Myrcene
A Phase 1 study testing THC and Beta-Myrcene in people with Cannabis Use, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- THC and Beta-Myrcene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
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
- Cannabis Use
- Being tested
- Placebo, THC, Beta-Myrcene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo (ambient air)
THCDrug
Also called Cannabis
Pure THC vapor
Beta-MyrceneDrug
Pure beta-myrcene vapor
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (ambient air) Receives: Drug: Placebo |
| Vaporized high THC alone | Experimental | 30mg of vaporized pure THC Receives: Drug: THC |
| Vaporized low THC alone | Experimental | 15mg of vaporized pure THC Receives: Drug: THC |
| Vaporized low beta-myrcene | Experimental | 2mg of vaporized beta-myrcene Receives: Drug: Beta-Myrcene |
| Vaporized high beta-myrcene | Experimental | 9mg of vaporized beta-myrcene Receives: Drug: Beta-Myrcene |
| Vaporized low THC and low beta-myrcene | Experimental | 15mg vaporized THC with 2mg vaporized beta-myrcene Receives: Drug: THC; Drug: Beta-Myrcene |
| Vaporized low THC and high beta-myrcene | Experimental | 15mg vaporized THC with 9mg vaporized beta-myrcene Receives: Drug: THC; Drug: Beta-Myrcene |
| Vaporized high THC and low beta-myrcene | Experimental | 30mg vaporized THC with 2mg vaporized beta-myrcene Receives: Drug: THC; Drug: Beta-Myrcene |
| Vaporized high THC and high beta-myrcene | Experimental | 30mg vaporized THC with 9mg vaporized beta-myrcene Receives: Drug: THC; Drug: Beta-Myrcene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (1)
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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study startJul 2027 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ryan Vandrey, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432284
- Sponsor's protocol ID
- IRB00329344
- Other IDs
- R01DA043475
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Pharmacology of THC and Beta-Myrcene
- ClinicalTrials.gov ID
- NCT05432284
- Acronym / sponsor ID
- IRB00329344
- Conditions
- Cannabis Use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2027 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (ambient air) |
| Vaporized high THC alone | Experimental | Drug: THC30mg of vaporized pure THC |
| Vaporized low THC alone | Experimental | Drug: THC15mg of vaporized pure THC |
| Vaporized low beta-myrcene | Experimental | Drug: Beta-Myrcene2mg of vaporized beta-myrcene |
| Vaporized high beta-myrcene | Experimental | Drug: Beta-Myrcene9mg of vaporized beta-myrcene |
| Vaporized low THC and low beta-myrcene | Experimental | Drug: THC, Drug: Beta-Myrcene15mg vaporized THC with 2mg vaporized beta-myrcene |
| Vaporized low THC and high beta-myrcene | Experimental | Drug: THC, Drug: Beta-Myrcene15mg vaporized THC with 9mg vaporized beta-myrcene |
| Vaporized high THC and low beta-myrcene | Experimental | Drug: THC, Drug: Beta-Myrcene30mg vaporized THC with 2mg vaporized beta-myrcene |
| Vaporized high THC and high beta-myrcene | Experimental | Drug: THC, Drug: Beta-Myrcene30mg vaporized THC with 9mg vaporized beta-myrcene |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo (ambient air) | Drug | Placebo |
| THCAlso: CannabisPure THC vapor | Drug | 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-MyrcenePure beta-myrcene vapor | Drug | 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 |
Primary outcome
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.
1 secondary outcome
Self-reported "Tired/Sleepy" as assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Vandrey, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THC and Beta-Myrcene in people with Cannabis Use, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Vandrey, PhD (410-550-4036, rvandrey@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ) (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.