Behavioral Pharmacology of THC and Alpha-pinene

• ClinicalTrials.gov Identifier: NCT04130633
• Recruitment Status: Recruiting
• First Posted: October 17, 2019
• Last Update Posted: January 6, 2023
• Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
THC; Alpha-pinene	Drug: Placebo; Drug: THC; Drug: Alpha-Pinene	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, pinene alone, THC and pinene together, or placebo. Subjective drug effects, cognitive performance, 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 the investigators understand the individual and interactive effects of THC and pinene, two common constituents found in cannabis.

Study Design

• 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 Alpha-pinene
• Actual Study Start Date: November 5, 2020
• Estimated Primary Completion Date: January 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo (5mL distilled water)	Drug: Placebo; Placebo vapor (distilled water)
Experimental: Vaporized high THC alone; 25mg of vaporized pure THC	Drug: THC; Pure THC vapor
Experimental: Vaporized low alpha-pinene; 0.5mg of vaporized alpha-pinene	Drug: Alpha-Pinene; Pure alpha-pinene vapor
Experimental: Vaporized high alpha-pinene; 5mg of vaporized alpha-pinene	Drug: Alpha-Pinene; Pure alpha-pinene vapor
Experimental: Vaporized high THC and low alpha-pinene; 0.5mg of vaporized alpha-pinene with 25mg vaporized THC	Drug: THC; Pure THC vapor; Drug: Alpha-Pinene; Pure alpha-pinene vapor
Experimental: Vaporized high THC and high alpha-pinene; 5mg of vaporized alpha-pinene with 25mg vaporized THC	Drug: THC; Pure THC vapor; Drug: Alpha-Pinene; Pure alpha-pinene vapor
Experimental: Vaporized low THC alone; 10mg of vaporized pure THC	Drug: THC; Pure THC vapor
Experimental: Vaporized low THC and low alpha-pinene; 0.5mg of vaporized alpha-pinene with 10mg vaporized THC	Drug: THC; Pure THC vapor; Drug: Alpha-Pinene; Pure alpha-pinene vapor
Experimental: Vaporized low THC and high alpha-pinene; 5mg of vaporized alpha-pinene with 10mg vaporized THC	Drug: THC; Pure THC vapor; Drug: Alpha-Pinene; Pure alpha-pinene vapor

Outcome Measures

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.
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 (PASAT) [ 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).

Eligibility Criteria

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

Criteria

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, 12-lead ECG 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 (THC, pinene).
• Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score of 75/90).

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 over-the-counter (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 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 dronabinol (Marinol®) within the past month.
• Average use of cannabis more than 2 times per week in the prior 3 months.
• History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
• Abnormal EKG result that in the investigator's opinion is clinically significant.
• Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
• Having previously sought medical attention to manage adverse effects following acute cannabis use.
• Individuals with anemia or who have donated blood in the prior 30 days

Contacts and Locations

Contacts

Contact: Ryan Vandrey, PhD; 410-550-4036; rvandrey@jhmi.edu

Locations

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21224

Contact: Ryan Vandrey rvandrey@jhmi.edu

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Ryan Vandrey, PhD; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04130633
• Other Study ID Numbers: IRB00182689; R01DA043475 ( U.S. NIH Grant/Contract )
• First Posted: October 17, 2019
• Last Update Posted: January 6, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No