Behavioral Pharmacology of THC and D-limonene

NCT03609853 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: IRB00085652R01DA043475
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

D-limonene and THC Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

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

  Peak rating (0-100) of Anxiety on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No anxiety and 100 being maximum anxiety

  0-6 hours

Secondary Outcomes (3)

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

  0-6 hours

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

  0-6 hours

• Mean Peak Change From Baseline Heart Rate

  0-6 hours

Study Arms (10)

Placebo

PLACEBO COMPARATOR

Placebo (5mL distilled water)

Drug: Placebo

Vaporized low THC

EXPERIMENTAL

15mg of pure THC

Drug: Vaporized THC, limonene, or THC and limonene

Vaporized high THC

EXPERIMENTAL

30mg of pure THC

Drug: Vaporized THC, limonene, or THC and limonene

Vaporized low d-limonene

EXPERIMENTAL

1mg of d-limonene

Drug: Vaporized THC, limonene, or THC and limonene

Vaporized high d-limonene

EXPERIMENTAL

5mg of d-limonene

Drug: Vaporized THC, limonene, or THC and limonene

Low THC and low d-limonene

EXPERIMENTAL

15mg of THC paired with 1mg of d-limonene

Drug: Vaporized THC, limonene, or THC and limonene

High THC and low d-limonene

EXPERIMENTAL

30mg of THC paired with 1mg of d-limonene

Drug: Vaporized THC, limonene, or THC and limonene

Low THC and high d-limonene

EXPERIMENTAL

15mg of THC paired with 5mg of d-limonene

Drug: Vaporized THC, limonene, or THC and limonene

High THC and high d-limonene

EXPERIMENTAL

30mg of THC paired with 5mg of d-limonene

Drug: Vaporized THC, limonene, or THC and limonene

High THC and 15mg d-limonene

EXPERIMENTAL

30mg of THC paired with 15mg of d-limonene

Drug: Vaporized THC, limonene, or THC and limonene

Interventions

Placebo DRUG

Placebo vapor (distilled water)

Placebo

Vaporized THC, limonene, or THC and limonene DRUG

Acute drug exposure

High THC and 15mg d-limonene; High THC and high d-limonene; High THC and low d-limonene; Low THC and high d-limonene; Low THC and low d-limonene; Vaporized high THC; Vaporized high d-limonene; Vaporized low THC; Vaporized low d-limonene

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, d-limonene).
• Report having experienced anxiety after consuming cannabis in the past.

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, 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 Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Limonene; Dronabinol

Intervention Hierarchy (Ancestors)

Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Monoterpenes; Terpenes; Cannabinoids

Results Point of Contact

• Title: Dr. Ryan Vandrey
• Organization: Johns Hopkins School of Medicine

rvandrey@jhmi.edu

410-550-4036

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

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 1, 2018
• Study Start: April 1, 2019
• Primary Completion: June 28, 2022
• Study Completion: October 25, 2023
• Last Updated: December 11, 2023
• Results First Posted: October 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)