Status:
ACTIVE_NOT_RECRUITING
Analgesic and Subjective Effects of Terpenes
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Pain
Abuse, Drug
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
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 bet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04451863
Start Date
December 15 2021
End Date
April 30 2026
Last Update
December 24 2025
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095