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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
Timeline
Screening 2 days
Treatment 2 months
Follow Up 7 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 21 and 55 years old and not pregnant.
Select...
I have used cannabis for non-medical reasons 1-7 times a week in the last month.

Timeline

Screening ~ 2 days
Treatment ~ 2 months
Follow Up ~7 hours
This trial's timeline: 2 days for screening, 2 months for treatment, and 7 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analgesia as measured using the Cold Pressor Test
Subject-rated drug effects of abuse liability
Secondary outcome measures
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
832 Previous Clinical Trials
668,888 Total Patients Enrolled
33 Trials studying Pain
19,735 Patients Enrolled for Pain
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,157 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings to participate in this research initiative?

"Accurate. Clinicaltrials.gov shows that this experiment is actively enlisting participants, with the first posting occurring on November 10th 2021 and an update to the listing made on the same day. 45 individuals need to be gathered from a single medical site."

Answered by AI

What risks exist for individuals who consume low THC and Low BCP?

"Owing to the preliminary nature of this clinical trial, it was assigned a score of 1 when assessed for safety. Low THC + Low BCP has yet to accumulate substantial evidence in support of efficacy or harmlessness."

Answered by AI

What is the scope of participants for this research study?

"Affirmative, according to information published on clinicaltrials.gov this medical trial is currently enrolling participants. It was initially posted on November 10th 2021 and modified for the last time that same day. 45 individuals are required from a single site in order complete recruitment goals."

Answered by AI

Who has the opportunity to participate in this trial?

"This medical experiment is open to 45 individuals aged 21 - 55 with existing pain. In addition, the entrants must meet these supplementary requirements: habitually use cannabis 2-6 days each week without seeking treatment, identify as male or a non-pregnant female, and have a Body Mass Index within 18.5 - 34kg/m2 range."

Answered by AI

Is the eligibility criteria of this study open to individuals above 40 years old?

"This medical study seeks participants between the age of 21 and 55 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Hi my motivation to contact you regarding this study. I like to be in researches. Give my body , time, and interview, answer questions. Plus this will be my first. THC study.
PatientReceived 1 prior treatment
I believe this trial will not only help me with my substance abuse issue but my pain as well why not kill 3 birds with 1 stone. The 3rd being helping other people in my position.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the study? Do you provide detoxification?
PatientReceived no prior treatments
~3 spots leftby Jul 2024