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Behavioral Pharmacology of THC and Beta-Myrcene

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ClinicalTrials.gov Identifier: NCT05432284
Recruitment Status : Not yet recruiting
First Posted : June 27, 2022
Last Update Posted : September 7, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment Phase
Cannabis Use Drug: Placebo Drug: THC Drug: Beta-Myrcene Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will complete all dose conditions (study arms) in a randomized order
Masking: Double (Participant, Outcomes Assessor)
Masking Description: placebo controlled, double blind
Primary Purpose: Basic Science
Official Title: Behavioral Pharmacology of THC and Beta-Myrcene
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (ambient air)
Drug: Placebo
Placebo (ambient air)

Experimental: Vaporized high THC alone
30mg of vaporized pure THC
Drug: THC
Pure THC vapor
Other Name: Cannabis

Experimental: Vaporized low THC alone
15mg of vaporized pure THC
Drug: THC
Pure THC vapor
Other Name: Cannabis

Experimental: Vaporized low beta-myrcene
2mg of vaporized beta-myrcene
Drug: Beta-Myrcene
Pure beta-myrcene vapor

Experimental: Vaporized high beta-myrcene
9mg of vaporized beta-myrcene
Drug: Beta-Myrcene
Pure beta-myrcene vapor

Experimental: Vaporized low THC and low beta-myrcene
15mg vaporized THC with 2mg vaporized beta-myrcene
Drug: THC
Pure THC vapor
Other Name: Cannabis

Drug: Beta-Myrcene
Pure beta-myrcene vapor

Experimental: Vaporized low THC and high beta-myrcene
15mg vaporized THC with 9mg vaporized beta-myrcene
Drug: THC
Pure THC vapor
Other Name: Cannabis

Drug: Beta-Myrcene
Pure beta-myrcene vapor

Experimental: Vaporized high THC and low beta-myrcene
30mg vaporized THC with 2mg vaporized beta-myrcene
Drug: THC
Pure THC vapor
Other Name: Cannabis

Drug: Beta-Myrcene
Pure beta-myrcene vapor

Experimental: Vaporized high THC and high beta-myrcene
30mg vaporized THC with 9mg vaporized beta-myrcene
Drug: THC
Pure THC vapor
Other Name: Cannabis

Drug: Beta-Myrcene
Pure beta-myrcene vapor




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432284


Contacts
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Contact: Ryan Vandrey, PhD 410-550-4036 rvandrey@jhmi.edu
Contact: Tory Spindle, PhD 410-550-0529 tspindle@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05432284    
Other Study ID Numbers: IRB00329344
R01DA043475 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders