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Analgesic and Subjective Effects of Terpenes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451863
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : January 5, 2023
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Ziva D. Cooper, PhD, University of California, Los Angeles

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

Condition or disease Intervention/treatment Phase
Pain Abuse, Drug Drug: Low THC Drug: High THC Drug: Low Myrcene Drug: High Myrcene Drug: Low Beta-Caryophyllene Drug: High Beta-Caryophyllene Drug: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : March 1, 2025
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Analgesia as measured using the Cold Pressor Test [ Time Frame: 7 hours ]
    Pain threshold and pain tolerance assessed using the Cold Pressor Test

  2. Subject-rated drug effects of abuse liability [ Time Frame: 7 hours ]
    Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)


Secondary Outcome Measures :
  1. Subject-rated drug effects of intoxication [ Time Frame: 7 hours ]
    Subject ratings of "High" as measured using a visual analog scale (1-100 mm)

  2. Subjective ratings of pain [ Time Frame: 7 hours ]
    Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451863


Contacts
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Contact: Ziva Cooper, PhD 310-206-9942 zcooper@mednet.ucla.edu
Contact: Vincent Acebo 310-983-3417 vacebo@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Ziva Cooper, Phd    310-206-9942    zcooper@mednet.ucla.edu   
Contact: Vincent Acebo    310-983-3417    vacebo@mednet.ucla.edu   
Principal Investigator: Ziva Cooper, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Ziva Cooper, PhD University of California, Los Angeles
More Information
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Responsible Party: Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04451863    
Other Study ID Numbers: 19-001519
R01AT010762 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziva D. Cooper, PhD, University of California, Los Angeles:
Cannabis
Analgesia
Pain
THC
Terpenes
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Caryophyllene
Physiological Effects of Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents