Effects of terpenes on pain relief and intoxication
Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination with THC
This study is testing if certain plant compounds called terpenes can help relieve pain and how they affect feelings of being high when used with THC.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04451863 on ClinicalTrials.gov |
What this trial studies
This research evaluates the analgesic and subjective effects of terpenes, specifically myrcene and beta-caryophyllene, both alone and in combination with THC. It is a placebo-controlled Phase 1 study that aims to determine the dose-dependent effects on pain relief, intoxication levels, and potential for abuse. Participants will be administered vaporized doses of these compounds to assess their pharmacokinetics and overall impact on pain management.
Who should consider this trial
Good fit: Ideal candidates are healthy males or non-pregnant females aged 21-55 who use cannabis non-medically several times a week.
Not a fit: Patients with a substance use disorder or those using cannabis primarily for medical purposes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into alternative pain management strategies using terpenes and THC.
How similar studies have performed: While the use of terpenes in pain management is an emerging area, similar studies have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Ziva Cooper, PhD — University of California, Los Angeles
- Study coordinator: Ziva Cooper, PhD
- Email: zcooper@mednet.ucla.edu
- Phone: 310-206-9942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.