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Terpenes

Terpenes + THC for Pain

Phase 1
Recruiting
Led By Ziva Cooper, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Current pain
History of respiratory illness or current respiratory illness
Timeline
Screening 2 days
Treatment 2 months
Follow Up 0 days

Summary

This trial is looking at whether terpenes can help relieve pain when used alone or in combination with THC.

Who is the study for?
This trial is for adults aged 21-55 who use cannabis recreationally 1-7 times a week and are not seeking treatment for cannabis use. They must have a BMI of 18.5 - 34kg/m2, be able to do all study tasks, and use contraception. People with significant illnesses, pregnant women, those allergic to cannabis or on certain medications can't join.
What is being tested?
The study aims to evaluate the pain-relief and subjective effects of terpenes both alone and when combined with THC. Participants will receive varying levels of Beta-Caryophyllene (high/low), Myrcene (high/low), THC (high/low), or placebo in different sessions.
What are the potential side effects?
Possible side effects may include typical reactions to cannabis such as changes in mood, sensory perception, altered cognitive function, dry mouth, red eyes, increased appetite and possible discomfort from the Cold Pressor Test used in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 55 years old and not pregnant.
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I have used cannabis for non-medical reasons 1-7 times a week in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am experiencing pain.
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I have or had a lung or breathing problem.
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I have a history of seizures or currently experience seizures.

Timeline

Screening ~ 2 days
Treatment ~ 2 months
Follow Up ~0 days
This trial's timeline: 2 days for screening, 2 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Analgesia as measured using the Cold Pressor Test
Subject-rated drug effects of abuse liability
Secondary study objectives
Subject-rated drug effects of intoxication
Subjective ratings of pain

Trial Design

15Treatment groups
Active Control
Placebo Group
Group I: Low strength BCPActive Control1 Intervention
0 mg THC, 0 mg myrcene, 0.5 mg BCP
Group II: High strength myrceneActive Control1 Intervention
0 mg THC, 12.0 mg myrcene, 0 mg BCP
Group III: High THC + Low myrcerneActive Control2 Interventions
15 mg THC, 0.5 mg myrcene, 0 mg BCP
Group IV: High strength BCPActive Control2 Interventions
15 mg THC, 0 mg myrcene, 7.5 mg BCP
Group V: Low strength myrceneActive Control1 Intervention
0 mg THC, 0.5 mg myrcene, 0 mg BCP
Group VI: Higher strength THCActive Control1 Intervention
15 mg THC, 0 mg myrcene, 0 mg BCP
Group VII: High THC + High BCPActive Control2 Interventions
15 mg THC, 0 mg myrcene, 7.5 mg BCP
Group VIII: Low THC + Low myrceneActive Control2 Interventions
5 mg THC, 0.5 mg myrcene, 0 mg BCP
Group IX: Low THC + High myrceneActive Control2 Interventions
5 mg THC, 12.0 mg myrcene, 0 mg BCP
Group X: High THC + High myrceneActive Control2 Interventions
15 mg THC, 12.0 mg myrcene, 0 mg BCP
Group XI: Low THC + Low BCPActive Control2 Interventions
5 mg THC, 0 mg myrcene, 0.5 mg BCP
Group XII: Low THC + High BCPActive Control2 Interventions
5 mg THC, 0 mg myrcene, 7.5 mg BCP
Group XIII: High THC + Low BCPActive Control2 Interventions
15 mg THC, 0 mg myrcene, 0.5 mg BCP
Group XIV: Low strength THCActive Control1 Intervention
5 mg THC, 0 mg myrcene, 0 mg BCP
Group XV: PlaceboPlacebo Group1 Intervention
0 mg THC, 0 mg myrcene, 0 mg BCP

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
866 Previous Clinical Trials
674,791 Total Patients Enrolled
39 Trials studying Pain
22,033 Patients Enrolled for Pain
University of California, Los AngelesLead Sponsor
1,568 Previous Clinical Trials
10,314,227 Total Patients Enrolled
9 Trials studying Pain
1,357 Patients Enrolled for Pain
Ziva Cooper, PhDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
352 Total Patients Enrolled
2 Trials studying Pain
263 Patients Enrolled for Pain

Media Library

High Beta-Caryophyllene (Terpenes) Clinical Trial Eligibility Overview. Trial Name: NCT04451863 — Phase 1
Pain Research Study Groups: Placebo, Low strength BCP, High strength myrcene, High THC + Low myrcerne, High strength BCP, Low strength myrcene, Higher strength THC, High THC + High BCP, Low THC + Low myrcene, Low THC + High myrcene, High THC + High myrcene, Low THC + Low BCP, Low THC + High BCP, High THC + Low BCP, Low strength THC
Pain Clinical Trial 2023: High Beta-Caryophyllene Highlights & Side Effects. Trial Name: NCT04451863 — Phase 1
High Beta-Caryophyllene (Terpenes) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04451863 — Phase 1
Pain Patient Testimony for trial: Trial Name: NCT04451863 — Phase 1
~6 spots leftby Jul 2025
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