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Analgesic and Subjective Effects of Terpenes

Primary Purpose

Pain, Abuse, Drug

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low THC
High THC
Low Myrcene
High Myrcene
Low Beta-Caryophyllene
High Beta-Caryophyllene
Placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Cannabis, Analgesia, Pain, THC, Terpenes

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or non-pregnant female aged 21-55 years
  • Report non-medical use of cannabis 2-6 days per week
  • 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 revealed any significant illness (e.g., hypertension)
  • Current use of medical cannabis, 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

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Low strength THC

Higher strength THC

Low strength myrcene

High strength myrcene

Low strength BCP

High strength BCP

Low THC + Low myrcene

Low THC + High myrcene

High THC + Low myrcerne

High THC + High myrcene

Low THC + Low BCP

Low THC + High BCP

High THC + Low BCP

High THC + High BCP

Arm Description

0 mg THC, 0 mg myrcene, 0 mg BCP

5 mg THC, 0 mg myrcene, 0 mg BCP

15 mg THC, 0 mg myrcene, 0 mg BCP

0 mg THC, 0.5 mg myrcene, 0 mg BCP

0 mg THC, 12.0 mg myrcene, 0 mg BCP

0 mg THC, 0 mg myrcene, 0.5 mg BCP

15 mg THC, 0 mg myrcene, 7.5 mg BCP

5 mg THC, 0.5 mg myrcene, 0 mg BCP

5 mg THC, 12.0 mg myrcene, 0 mg BCP

15 mg THC, 0.5 mg myrcene, 0 mg BCP

15 mg THC, 12.0 mg myrcene, 0 mg BCP

5 mg THC, 0 mg myrcene, 0.5 mg BCP

5 mg THC, 0 mg myrcene, 7.5 mg BCP

15 mg THC, 0 mg myrcene, 0.5 mg BCP

15 mg THC, 0 mg myrcene, 7.5 mg BCP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2020
Last Updated
January 4, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04451863
Brief Title
Analgesic and Subjective Effects of Terpenes
Official Title
Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Abuse, Drug
Keywords
Cannabis, Analgesia, Pain, THC, Terpenes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 mg THC, 0 mg myrcene, 0 mg BCP
Arm Title
Low strength THC
Arm Type
Active Comparator
Arm Description
5 mg THC, 0 mg myrcene, 0 mg BCP
Arm Title
Higher strength THC
Arm Type
Active Comparator
Arm Description
15 mg THC, 0 mg myrcene, 0 mg BCP
Arm Title
Low strength myrcene
Arm Type
Active Comparator
Arm Description
0 mg THC, 0.5 mg myrcene, 0 mg BCP
Arm Title
High strength myrcene
Arm Type
Active Comparator
Arm Description
0 mg THC, 12.0 mg myrcene, 0 mg BCP
Arm Title
Low strength BCP
Arm Type
Active Comparator
Arm Description
0 mg THC, 0 mg myrcene, 0.5 mg BCP
Arm Title
High strength BCP
Arm Type
Active Comparator
Arm Description
15 mg THC, 0 mg myrcene, 7.5 mg BCP
Arm Title
Low THC + Low myrcene
Arm Type
Active Comparator
Arm Description
5 mg THC, 0.5 mg myrcene, 0 mg BCP
Arm Title
Low THC + High myrcene
Arm Type
Active Comparator
Arm Description
5 mg THC, 12.0 mg myrcene, 0 mg BCP
Arm Title
High THC + Low myrcerne
Arm Type
Active Comparator
Arm Description
15 mg THC, 0.5 mg myrcene, 0 mg BCP
Arm Title
High THC + High myrcene
Arm Type
Active Comparator
Arm Description
15 mg THC, 12.0 mg myrcene, 0 mg BCP
Arm Title
Low THC + Low BCP
Arm Type
Active Comparator
Arm Description
5 mg THC, 0 mg myrcene, 0.5 mg BCP
Arm Title
Low THC + High BCP
Arm Type
Active Comparator
Arm Description
5 mg THC, 0 mg myrcene, 7.5 mg BCP
Arm Title
High THC + Low BCP
Arm Type
Active Comparator
Arm Description
15 mg THC, 0 mg myrcene, 0.5 mg BCP
Arm Title
High THC + High BCP
Arm Type
Active Comparator
Arm Description
15 mg THC, 0 mg myrcene, 7.5 mg BCP
Intervention Type
Drug
Intervention Name(s)
Low THC
Intervention Description
Vaporized THC (5 mg)
Intervention Type
Drug
Intervention Name(s)
High THC
Intervention Description
Vaporized THC (15 mg)
Intervention Type
Drug
Intervention Name(s)
Low Myrcene
Intervention Description
Vaporized Myrcene (0.5 mg)
Intervention Type
Drug
Intervention Name(s)
High Myrcene
Intervention Description
Vaporized Myrcene (12.0 mg)
Intervention Type
Drug
Intervention Name(s)
Low Beta-Caryophyllene
Intervention Description
Vaporized Beta-Caryophyllene (0.5 mg)
Intervention Type
Drug
Intervention Name(s)
High Beta-Caryophyllene
Intervention Description
Vaporized Beta-Caryophyllene (7.5 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vaporized Placebo
Primary Outcome Measure Information:
Title
Analgesia as measured using the Cold Pressor Test
Description
Pain threshold and pain tolerance assessed using the Cold Pressor Test
Time Frame
7 hours
Title
Subject-rated drug effects of abuse liability
Description
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
Time Frame
7 hours
Secondary Outcome Measure Information:
Title
Subject-rated drug effects of intoxication
Description
Subject ratings of "High" as measured using a visual analog scale (1-100 mm)
Time Frame
7 hours
Title
Subjective ratings of pain
Description
Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test
Time Frame
7 hours

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziva Cooper, PhD
Phone
310-206-9942
Email
zcooper@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Acebo
Phone
310-983-3417
Email
vacebo@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, Phd
Phone
310-206-9942
Email
zcooper@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Vincent Acebo
Phone
310-983-3417
Email
vacebo@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Analgesic and Subjective Effects of Terpenes

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