Analgesic and Subjective Effects of Terpenes

NCT ID: NCT04451863

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Abuse, Drug

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cannabis Analgesia Pain THC Terpenes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

0 mg THC, 0 mg myrcene, 0 mg BCP

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vaporized Placebo

Low strength THC

5 mg THC, 0 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

Higher strength THC

15 mg THC, 0 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

Low strength myrcene

0 mg THC, 0.5 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

Low Myrcene

Intervention Type DRUG

Vaporized Myrcene (0.5 mg)

High strength myrcene

0 mg THC, 12.0 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

High Myrcene

Intervention Type DRUG

Vaporized Myrcene (12.0 mg)

Low strength BCP

0 mg THC, 0 mg myrcene, 0.5 mg BCP

Group Type ACTIVE_COMPARATOR

Low Beta-Caryophyllene

Intervention Type DRUG

Vaporized Beta-Caryophyllene (0.5 mg)

High strength BCP

15 mg THC, 0 mg myrcene, 7.5 mg BCP

Group Type ACTIVE_COMPARATOR

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

High Beta-Caryophyllene

Intervention Type DRUG

Vaporized Beta-Caryophyllene (7.5 mg)

Low THC + Low myrcene

5 mg THC, 0.5 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

Low Myrcene

Intervention Type DRUG

Vaporized Myrcene (0.5 mg)

Low THC + High myrcene

5 mg THC, 12.0 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

High Myrcene

Intervention Type DRUG

Vaporized Myrcene (12.0 mg)

High THC + Low myrcerne

15 mg THC, 0.5 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

Low Myrcene

Intervention Type DRUG

Vaporized Myrcene (0.5 mg)

High THC + High myrcene

15 mg THC, 12.0 mg myrcene, 0 mg BCP

Group Type ACTIVE_COMPARATOR

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

High Myrcene

Intervention Type DRUG

Vaporized Myrcene (12.0 mg)

Low THC + Low BCP

5 mg THC, 0 mg myrcene, 0.5 mg BCP

Group Type ACTIVE_COMPARATOR

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

Low Beta-Caryophyllene

Intervention Type DRUG

Vaporized Beta-Caryophyllene (0.5 mg)

Low THC + High BCP

5 mg THC, 0 mg myrcene, 7.5 mg BCP

Group Type ACTIVE_COMPARATOR

Low THC

Intervention Type DRUG

Vaporized THC (5 mg)

High Beta-Caryophyllene

Intervention Type DRUG

Vaporized Beta-Caryophyllene (7.5 mg)

High THC + Low BCP

15 mg THC, 0 mg myrcene, 0.5 mg BCP

Group Type ACTIVE_COMPARATOR

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

Low Beta-Caryophyllene

Intervention Type DRUG

Vaporized Beta-Caryophyllene (0.5 mg)

High THC + High BCP

15 mg THC, 0 mg myrcene, 7.5 mg BCP

Group Type ACTIVE_COMPARATOR

High THC

Intervention Type DRUG

Vaporized THC (15 mg)

High Beta-Caryophyllene

Intervention Type DRUG

Vaporized Beta-Caryophyllene (7.5 mg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low THC

Vaporized THC (5 mg)

Intervention Type DRUG

High THC

Vaporized THC (15 mg)

Intervention Type DRUG

Low Myrcene

Vaporized Myrcene (0.5 mg)

Intervention Type DRUG

High Myrcene

Vaporized Myrcene (12.0 mg)

Intervention Type DRUG

Low Beta-Caryophyllene

Vaporized Beta-Caryophyllene (0.5 mg)

Intervention Type DRUG

High Beta-Caryophyllene

Vaporized Beta-Caryophyllene (7.5 mg)

Intervention Type DRUG

Placebo

Vaporized Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ziva D. Cooper, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ziva Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AT010762-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-001519

Identifier Type: -

Identifier Source: org_study_id