Health TrialsbyHealthPanel

Behavioral Pharmacology of THC and Beta-Myrcene

ConditionCannabis Use
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJohns Hopkins University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Placebo

    Drug

    Placebo (ambient air)

  • THC

    Drug

    Pure THC vapor

  • Beta-Myrcene

    Drug

    Pure beta-myrcene vapor

Treatment groups

32 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: PlaceboPlacebo comparator 1 intervention
Group B: Vaporized high THC aloneExperimental treatment 1 intervention
Group C: Vaporized low THC aloneExperimental treatment 1 intervention
Group D: Vaporized low beta-myrceneExperimental treatment 1 intervention
Group E: Vaporized high beta-myrceneExperimental treatment 1 intervention
Group F: Vaporized low THC and low beta-myrceneExperimental treatment 2 interventions
Group G: Vaporized low THC and high beta-myrceneExperimental treatment 2 interventions
Group H: Vaporized high THC and low beta-myrceneExperimental treatment 2 interventions
Group I: Vaporized high THC and high beta-myrceneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
6 hours

Other outcomes

1

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
2

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
3

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
4

Heart rate

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

Time frame
6 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: