Analgesic and Subjective Effects of Terpenes

Phase 1

Recruiting

• Conditions: Pain; Abuse, Drug
• Interventions: Drug: High THC; Drug: Low THC; Drug: Placebo; Drug: Low Beta-Caryophyllene; Drug: High Beta-Caryophyllene; Drug: High Myrcene; Drug: Low Myrcene

• Registration Number: NCT04451863
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.

Detailed Description

The overall aim of this placebo-controlled study is to examine dose-dependent analgesia, intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of vaporized myrcene and beta-caryophyllene administered alone or with vaporized THC.

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Study Start: 2021-12-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-07-15
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Male or non-pregnant female aged 21-55 years
• Report non-medical use of cannabis 1-7 days per week over the 1 month prior to screening
• Not currently seeking treatment for cannabis use
• Urine test positive for recent cannabis use
• Have a Body Mass Index from 18.5 - 34kg/m2.
• Able to perform all study procedures
• Must be using a contraceptive method (hormonal or barrier methods)

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Exclusion Criteria

• Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or mild CUD
• Report using other illicit drugs in the prior 4 weeks
• • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
• Current licit use of cannabis primarily for medical purposes, prescription analgesics, or any medications that may affect study outcomes
• Current pain
• Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
• History of an allergic reaction or adverse reaction to cannabis is exclusionary.
• History of respiratory illness or current respiratory illness
• History of seizure disorder or current seizure disorder
• Insensitivity to the cold water stimulus of the Cold Pressor Test
• Currently enrolled in another research protocol
• Current major Axis 1 disorders (mood, anxiety, or psychotic disorder)
• Not using a contraceptive method (hormonal or barrier methods)
• The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High strength BCP	High THC	15 mg THC, 0 mg myrcene, 7.5 mg BCP
Low THC + High BCP	Low THC	5 mg THC, 0 mg myrcene, 7.5 mg BCP
Low THC + Low BCP	Low THC	5 mg THC, 0 mg myrcene, 0.5 mg BCP
High THC + High myrcene	High THC	15 mg THC, 12.0 mg myrcene, 0 mg BCP
Low THC + Low BCP	Low Beta-Caryophyllene	5 mg THC, 0 mg myrcene, 0.5 mg BCP
High THC + Low BCP	High THC	15 mg THC, 0 mg myrcene, 0.5 mg BCP
Low THC + High BCP	High Beta-Caryophyllene	5 mg THC, 0 mg myrcene, 7.5 mg BCP
High THC + Low BCP	Low Beta-Caryophyllene	15 mg THC, 0 mg myrcene, 0.5 mg BCP
High THC + High BCP	High THC	15 mg THC, 0 mg myrcene, 7.5 mg BCP
Low strength BCP	Low Beta-Caryophyllene	0 mg THC, 0 mg myrcene, 0.5 mg BCP
Low strength THC	Low THC	5 mg THC, 0 mg myrcene, 0 mg BCP
Higher strength THC	High THC	15 mg THC, 0 mg myrcene, 0 mg BCP
Low THC + High myrcene	High Myrcene	5 mg THC, 12.0 mg myrcene, 0 mg BCP
High THC + Low myrcerne	Low Myrcene	15 mg THC, 0.5 mg myrcene, 0 mg BCP
Low strength myrcene	Low Myrcene	0 mg THC, 0.5 mg myrcene, 0 mg BCP
Low THC + Low myrcene	Low Myrcene	5 mg THC, 0.5 mg myrcene, 0 mg BCP
Placebo	Placebo	0 mg THC, 0 mg myrcene, 0 mg BCP
High strength myrcene	High Myrcene	0 mg THC, 12.0 mg myrcene, 0 mg BCP
High strength BCP	High Beta-Caryophyllene	15 mg THC, 0 mg myrcene, 7.5 mg BCP
Low THC + Low myrcene	Low THC	5 mg THC, 0.5 mg myrcene, 0 mg BCP
High THC + Low myrcerne	High THC	15 mg THC, 0.5 mg myrcene, 0 mg BCP
High THC + High myrcene	High Myrcene	15 mg THC, 12.0 mg myrcene, 0 mg BCP
Low THC + High myrcene	Low THC	5 mg THC, 12.0 mg myrcene, 0 mg BCP
High THC + High BCP	High Beta-Caryophyllene	15 mg THC, 0 mg myrcene, 7.5 mg BCP

Primary Outcome Measures

Name	Time	Method
Analgesia as measured using the Cold Pressor Test	7 hours	Pain threshold and pain tolerance assessed using the Cold Pressor Test
Subject-rated drug effects of abuse liability	7 hours	Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)

Secondary Outcome Measures

Name	Time	Method
Subject-rated drug effects of intoxication	7 hours	Subject ratings of "High" as measured using a visual analog scale (1-100 mm)
Subjective ratings of pain	7 hours	Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States