Behavioral Pharmacology of THC and Beta-Myrcene

Cannabis Use Clinical Trial

Official title:

Behavioral Pharmacology of THC and Beta-Myrcene

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432284
• Other study ID #: IRB00329344
• Secondary ID: R01DA043475
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2024
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Ryan Vandrey, PhD
• Phone: 410-550-4036
• Email: rvandrey[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use

Intervention

Drug:
• Placebo
Placebo (ambient air)
• THC
Pure THC vapor
• Beta-Myrcene
Pure beta-myrcene vapor

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Heart rate	Heart rate (beats/minute) will be measured while sitting down using the vitals machine.	6 hours
Other	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
Primary	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	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