Analgesic and Subjective Effects of Terpenes

Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Abuse, Drug
• Intervention / Treatment: Drug: Placebo; Drug: Low THC; Drug: High THC; Drug: Low Myrcene; Drug: High Myrcene; Drug: Low Beta-Caryophyllene; Drug: High Beta-Caryophyllene

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0 mg THC, 0 mg myrcene, 0 mg BCP	Drug: Placebo; Vaporized Placebo
Active Comparator: Low strength THC; 5 mg THC, 0 mg myrcene, 0 mg BCP	Drug: Low THC; Vaporized THC (5 mg)
Active Comparator: Higher strength THC; 15 mg THC, 0 mg myrcene, 0 mg BCP	Drug: High THC; Vaporized THC (15 mg)
Active Comparator: Low strength myrcene; 0 mg THC, 0.5 mg myrcene, 0 mg BCP	Drug: Low Myrcene; Vaporized Myrcene (0.5 mg)
Active Comparator: High strength myrcene; 0 mg THC, 12.0 mg myrcene, 0 mg BCP	Drug: High Myrcene; Vaporized Myrcene (12.0 mg)
Active Comparator: Low strength BCP; 0 mg THC, 0 mg myrcene, 0.5 mg BCP	Drug: Low Beta-Caryophyllene; Vaporized Beta-Caryophyllene (0.5 mg)
Active Comparator: High strength BCP; 15 mg THC, 0 mg myrcene, 7.5 mg BCP	Drug: High THC; Vaporized THC (15 mg); Drug: High Beta-Caryophyllene; Vaporized Beta-Caryophyllene (7.5 mg)
Active Comparator: Low THC + Low myrcene; 5 mg THC, 0.5 mg myrcene, 0 mg BCP	Drug: Low THC; Vaporized THC (5 mg); Drug: Low Myrcene; Vaporized Myrcene (0.5 mg)
Active Comparator: Low THC + High myrcene; 5 mg THC, 12.0 mg myrcene, 0 mg BCP	Drug: Low THC; Vaporized THC (5 mg); Drug: High Myrcene; Vaporized Myrcene (12.0 mg)
Active Comparator: High THC + Low myrcerne; 15 mg THC, 0.5 mg myrcene, 0 mg BCP	Drug: High THC; Vaporized THC (15 mg); Drug: Low Myrcene; Vaporized Myrcene (0.5 mg)
Active Comparator: High THC + High myrcene; 15 mg THC, 12.0 mg myrcene, 0 mg BCP	Drug: High THC; Vaporized THC (15 mg); Drug: High Myrcene; Vaporized Myrcene (12.0 mg)
Active Comparator: Low THC + Low BCP; 5 mg THC, 0 mg myrcene, 0.5 mg BCP	Drug: Low THC; Vaporized THC (5 mg); Drug: Low Beta-Caryophyllene; Vaporized Beta-Caryophyllene (0.5 mg)
Active Comparator: Low THC + High BCP; 5 mg THC, 0 mg myrcene, 7.5 mg BCP	Drug: Low THC; Vaporized THC (5 mg); Drug: High Beta-Caryophyllene; Vaporized Beta-Caryophyllene (7.5 mg)
Active Comparator: High THC + Low BCP; 15 mg THC, 0 mg myrcene, 0.5 mg BCP	Drug: High THC; Vaporized THC (15 mg); Drug: Low Beta-Caryophyllene; Vaporized Beta-Caryophyllene (0.5 mg)
Active Comparator: High THC + High BCP; 15 mg THC, 0 mg myrcene, 7.5 mg BCP	Drug: High THC; Vaporized THC (15 mg); Drug: High Beta-Caryophyllene; Vaporized Beta-Caryophyllene (7.5 mg)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Ziva Cooper, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): November 12, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Cannabis; THC; Terpenes
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Chemically-Induced Disorders; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Substance-Related Disorders; Marijuana Abuse; Agnosia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Caryophyllene
• Other Study ID Numbers: 19-001519; R01AT010762-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No