Behavioral Pharmacology of THC and Alpha-pinene

NCT04130633 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: IRB00182689R01DA043475
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

THC; Alpha-pinene

Outcome Measures

Primary Outcomes (3)

• Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)

  Mean Peak change from baseline rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.

  0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.

• Mean Peak Change From Baseline 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. Mean peak change from baseline total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).

  0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.

• Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)

  Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).

  0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Placebo (5mL distilled water)

Drug: Placebo

Vaporized Pinene

EXPERIMENTAL

15mg vaporized alpha-pinene

Drug: Alpha-Pinene

Vaporized THC

EXPERIMENTAL

30mg vaporized delta-9-THC

Drug: THC

Vaporized THC and low alpha-pinene

EXPERIMENTAL

30mg vaporized delta-9-THC and 0.5mg of vaporized alpha-pinene

Drug: THC; Drug: Alpha-Pinene

Vaporized THC and alpha-pinene

EXPERIMENTAL

30mg vaporized delta-9-THC and 5mg of vaporized alpha-pinene

Drug: THC; Drug: Alpha-Pinene

Vaporized THC and high alpha-pinene

EXPERIMENTAL

30mg vaporized delta-9-THC and 15mg of vaporized alpha-pinene

Drug: THC; Drug: Alpha-Pinene

Interventions

Placebo DRUG

Placebo vapor (distilled water)

Placebo

THC DRUG

Pure THC vapor

Also known as: Cannabis, Delta-9-THC

Vaporized THC; Vaporized THC and alpha-pinene; Vaporized THC and high alpha-pinene; Vaporized THC and low alpha-pinene

Alpha-Pinene DRUG

Pure alpha-pinene vapor

Also known as: Pinene

Vaporized Pinene; Vaporized THC and alpha-pinene; Vaporized THC and high alpha-pinene; Vaporized THC and low alpha-pinene

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Dronabinol; nabiximols; alpha-pinene

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: C. Austin Zamarripa, PhD
• Organization: Johns Hopkins University School of Medicine

czamarr2@jh.edu

410-550-6969

Study Officials

• Ryan Vandrey, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: placebo controlled, double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete all dose conditions (study arms) in a randomized order

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 17, 2019
• Study Start: November 5, 2020
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)