Analgesic and Subjective Effects of Terpenes

NCT04451863 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 19-001519R01AT010762-04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Abuse, Drug

Keywords

Cannabis; Analgesia; Pain; THC; Terpenes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Subject-rated drug effects of intoxication

  7 hours

• Subjective ratings of pain

  7 hours

Study Arms (15)

Placebo

PLACEBO COMPARATOR

0 mg THC, 0 mg myrcene, 0 mg BCP

Drug: Placebo

Low strength THC

ACTIVE COMPARATOR

5 mg THC, 0 mg myrcene, 0 mg BCP

Drug: Low THC

Higher strength THC

ACTIVE COMPARATOR

15 mg THC, 0 mg myrcene, 0 mg BCP

Drug: High THC

Low strength myrcene

ACTIVE COMPARATOR

0 mg THC, 0.5 mg myrcene, 0 mg BCP

Drug: Low Myrcene

High strength myrcene

ACTIVE COMPARATOR

0 mg THC, 12.0 mg myrcene, 0 mg BCP

Drug: High Myrcene

Low strength BCP

ACTIVE COMPARATOR

0 mg THC, 0 mg myrcene, 0.5 mg BCP

Drug: Low Beta-Caryophyllene

High strength BCP

ACTIVE COMPARATOR

15 mg THC, 0 mg myrcene, 7.5 mg BCP

Drug: High THC; Drug: High Beta-Caryophyllene

Low THC + Low myrcene

ACTIVE COMPARATOR

5 mg THC, 0.5 mg myrcene, 0 mg BCP

Drug: Low THC; Drug: Low Myrcene

Low THC + High myrcene

ACTIVE COMPARATOR

5 mg THC, 12.0 mg myrcene, 0 mg BCP

Drug: Low THC; Drug: High Myrcene

High THC + Low myrcerne

ACTIVE COMPARATOR

15 mg THC, 0.5 mg myrcene, 0 mg BCP

Drug: High THC; Drug: Low Myrcene

High THC + High myrcene

ACTIVE COMPARATOR

15 mg THC, 12.0 mg myrcene, 0 mg BCP

Drug: High THC; Drug: High Myrcene

Low THC + Low BCP

ACTIVE COMPARATOR

5 mg THC, 0 mg myrcene, 0.5 mg BCP

Drug: Low THC; Drug: Low Beta-Caryophyllene

Low THC + High BCP

ACTIVE COMPARATOR

5 mg THC, 0 mg myrcene, 7.5 mg BCP

Drug: Low THC; Drug: High Beta-Caryophyllene

High THC + Low BCP

ACTIVE COMPARATOR

15 mg THC, 0 mg myrcene, 0.5 mg BCP

Drug: High THC; Drug: Low Beta-Caryophyllene

High THC + High BCP

ACTIVE COMPARATOR

15 mg THC, 0 mg myrcene, 7.5 mg BCP

Drug: High THC; Drug: High Beta-Caryophyllene

Interventions

Low THC DRUG

Vaporized THC (5 mg)

Low THC + High BCP; Low THC + High myrcene; Low THC + Low BCP; Low THC + Low myrcene; Low strength THC

High THC DRUG

Vaporized THC (15 mg)

High THC + High BCP; High THC + High myrcene; High THC + Low BCP; High THC + Low myrcerne; High strength BCP; Higher strength THC

Low Myrcene DRUG

Vaporized Myrcene (0.5 mg)

High THC + Low myrcerne; Low THC + Low myrcene; Low strength myrcene

High Myrcene DRUG

Vaporized Myrcene (12.0 mg)

High THC + High myrcene; High strength myrcene; Low THC + High myrcene

Low Beta-Caryophyllene DRUG

Vaporized Beta-Caryophyllene (0.5 mg)

High THC + Low BCP; Low THC + Low BCP; Low strength BCP

High Beta-Caryophyllene DRUG

Vaporized Beta-Caryophyllene (7.5 mg)

High THC + High BCP; High strength BCP; Low THC + High BCP

Placebo DRUG

Vaporized Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Pain; Substance-Related Disorders; Marijuana Abuse; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Ziva Cooper, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: December 15, 2021
• Primary Completion: November 12, 2025
• Study Completion: April 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)