Analgesic and Subjective Effects of Terpenes

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451863
• Other study ID #: 19-001519
• Secondary ID: R01AT010762
• Status: Recruiting
• Phase: Phase 1
• Start date: December 15, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: Ziva Cooper, PhD
• Phone: 310-206-9942
• Email: zcooper[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 1, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abuse, Drug
• Pain
• Substance-Related Disorders

Intervention

Drug:
• Low THC
Vaporized THC (5 mg)
• High THC
Vaporized THC (15 mg)
• Low Myrcene
Vaporized Myrcene (0.5 mg)
• High Myrcene
Vaporized Myrcene (12.0 mg)
• Low Beta-Caryophyllene
Vaporized Beta-Caryophyllene (0.5 mg)
• High Beta-Caryophyllene
Vaporized Beta-Caryophyllene (7.5 mg)
• Placebo
Vaporized Placebo

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia as measured using the Cold Pressor Test	Pain threshold and pain tolerance assessed using the Cold Pressor Test	7 hours
Primary	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	Subject-rated drug effects of intoxication	Subject ratings of "High" as measured using a visual analog scale (1-100 mm)	7 hours
Secondary	Subjective ratings of pain	Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test	7 hours