PainPhase 1NCT04451863
Analgesic and Subjective Effects of Terpenes
A Phase 1 study testing Low THC, High THC and Low Myrcene in people with Pain and Abuse, Drug, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Abuse, Drug
- What is being tested?
- Low THC, High THC and Low Myrcene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC
The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.
Read the 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.
- Conditions
- Pain, Abuse, Drug
- Being tested
- Low THC, High THC, Low Myrcene, High Myrcene, Low Beta-Caryophyllene
- Keywords
- Cannabis, Analgesia, Pain, THC, Terpenes
- Medical subject headings
- Pain, Substance-Related Disorders, Marijuana Abuse, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low THCDrug
Vaporized THC (5 mg)
High THCDrug
Vaporized THC (15 mg)
Low MyrceneDrug
Vaporized Myrcene (0.5 mg)
High MyrceneDrug
Vaporized Myrcene (12.0 mg)
Low Beta-CaryophylleneDrug
Vaporized Beta-Caryophyllene (0.5 mg)
High Beta-CaryophylleneDrug
Vaporized Beta-Caryophyllene (7.5 mg)
PlaceboDrug
Vaporized Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0 mg THC, 0 mg myrcene, 0 mg BCP Receives: Drug: Placebo |
| Low strength THC | Active comparator | 5 mg THC, 0 mg myrcene, 0 mg BCP Receives: Drug: Low THC |
| Higher strength THC | Active comparator | 15 mg THC, 0 mg myrcene, 0 mg BCP Receives: Drug: High THC |
| Low strength myrcene | Active comparator | 0 mg THC, 0.5 mg myrcene, 0 mg BCP Receives: Drug: Low Myrcene |
| High strength myrcene | Active comparator | 0 mg THC, 12.0 mg myrcene, 0 mg BCP Receives: Drug: High Myrcene |
| Low strength BCP | Active comparator | 0 mg THC, 0 mg myrcene, 0.5 mg BCP Receives: Drug: Low Beta-Caryophyllene |
| High strength BCP | Active comparator | 15 mg THC, 0 mg myrcene, 7.5 mg BCP Receives: Drug: High THC; Drug: High Beta-Caryophyllene |
| Low THC + Low myrcene | Active comparator | 5 mg THC, 0.5 mg myrcene, 0 mg BCP Receives: Drug: Low THC; Drug: Low Myrcene |
| Low THC + High myrcene | Active comparator | 5 mg THC, 12.0 mg myrcene, 0 mg BCP Receives: Drug: Low THC; Drug: High Myrcene |
| High THC + Low myrcerne | Active comparator | 15 mg THC, 0.5 mg myrcene, 0 mg BCP Receives: Drug: High THC; Drug: Low Myrcene |
| High THC + High myrcene | Active comparator | 15 mg THC, 12.0 mg myrcene, 0 mg BCP Receives: Drug: High THC; Drug: High Myrcene |
| Low THC + Low BCP | Active comparator | 5 mg THC, 0 mg myrcene, 0.5 mg BCP Receives: Drug: Low THC; Drug: Low Beta-Caryophyllene |
| Low THC + High BCP | Active comparator | 5 mg THC, 0 mg myrcene, 7.5 mg BCP Receives: Drug: Low THC; Drug: High Beta-Caryophyllene |
| High THC + Low BCP | Active comparator | 15 mg THC, 0 mg myrcene, 0.5 mg BCP Receives: Drug: High THC; Drug: Low Beta-Caryophyllene |
| High THC + High BCP | Active comparator | 15 mg THC, 0 mg myrcene, 7.5 mg BCP Receives: Drug: High THC; Drug: High Beta-Caryophyllene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia as measured using the Cold Pressor Test
Pain threshold and pain tolerance assessed using the Cold Pressor Test
Measured: 7 hours
Subject-rated drug effects of abuse liability
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
Measured: 7 hours
Secondary outcomes (2)
Subject-rated drug effects of intoxication
Subject ratings of "High" as measured using a visual analog scale (1-100 mm)
Measured: 7 hours
Subjective ratings of pain
Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start15 Dec 2021
- Primary completion12 Nov 2025
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ziva D. Cooper, PhD, University of California, Los Angeles
- Investigators
- Ziva Cooper, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451863
- Sponsor's protocol ID
- 19-001519
- Other IDs
- R01AT010762-04
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC
- ClinicalTrials.gov ID
- NCT04451863
- Acronym / sponsor ID
- 19-001519
- Conditions
- Pain, Abuse, Drug
- Keywords
- Cannabis, Analgesia, Pain, THC, Terpenes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 15
- Model description
- This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo0 mg THC, 0 mg myrcene, 0 mg BCP |
| Low strength THC | Active comparator | Drug: Low THC5 mg THC, 0 mg myrcene, 0 mg BCP |
| Higher strength THC | Active comparator | Drug: High THC15 mg THC, 0 mg myrcene, 0 mg BCP |
| Low strength myrcene | Active comparator | Drug: Low Myrcene0 mg THC, 0.5 mg myrcene, 0 mg BCP |
| High strength myrcene | Active comparator | Drug: High Myrcene0 mg THC, 12.0 mg myrcene, 0 mg BCP |
| Low strength BCP | Active comparator | Drug: Low Beta-Caryophyllene0 mg THC, 0 mg myrcene, 0.5 mg BCP |
| High strength BCP | Active comparator | Drug: High THC, Drug: High Beta-Caryophyllene15 mg THC, 0 mg myrcene, 7.5 mg BCP |
| Low THC + Low myrcene | Active comparator | Drug: Low THC, Drug: Low Myrcene5 mg THC, 0.5 mg myrcene, 0 mg BCP |
| Low THC + High myrcene | Active comparator | Drug: Low THC, Drug: High Myrcene5 mg THC, 12.0 mg myrcene, 0 mg BCP |
| High THC + Low myrcerne | Active comparator | Drug: High THC, Drug: Low Myrcene15 mg THC, 0.5 mg myrcene, 0 mg BCP |
| High THC + High myrcene | Active comparator | Drug: High THC, Drug: High Myrcene15 mg THC, 12.0 mg myrcene, 0 mg BCP |
| Low THC + Low BCP | Active comparator | Drug: Low THC, Drug: Low Beta-Caryophyllene5 mg THC, 0 mg myrcene, 0.5 mg BCP |
| Low THC + High BCP | Active comparator | Drug: Low THC, Drug: High Beta-Caryophyllene5 mg THC, 0 mg myrcene, 7.5 mg BCP |
| High THC + Low BCP | Active comparator | Drug: High THC, Drug: Low Beta-Caryophyllene15 mg THC, 0 mg myrcene, 0.5 mg BCP |
| High THC + High BCP | Active comparator | Drug: High THC, Drug: High Beta-Caryophyllene15 mg THC, 0 mg myrcene, 7.5 mg BCP |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low THCVaporized THC (5 mg) | Drug | Low THC + High BCP, Low THC + High myrcene, Low THC + Low BCP, Low THC + Low myrcene, Low strength THC |
| High THCVaporized THC (15 mg) | Drug | High THC + High BCP, High THC + High myrcene, High THC + Low BCP, High THC + Low myrcerne, High strength BCP, Higher strength THC |
| Low MyrceneVaporized Myrcene (0.5 mg) | Drug | High THC + Low myrcerne, Low THC + Low myrcene, Low strength myrcene |
| High MyrceneVaporized Myrcene (12.0 mg) | Drug | High THC + High myrcene, High strength myrcene, Low THC + High myrcene |
| Low Beta-CaryophylleneVaporized Beta-Caryophyllene (0.5 mg) | Drug | High THC + Low BCP, Low THC + Low BCP, Low strength BCP |
| High Beta-CaryophylleneVaporized Beta-Caryophyllene (7.5 mg) | Drug | High THC + High BCP, High strength BCP, Low THC + High BCP |
| PlaceboVaporized Placebo | Drug | Placebo |
Primary outcome
Analgesia as measured using the Cold Pressor Test
Time frame: 7 hours
Pain threshold and pain tolerance assessed using the Cold Pressor Test
Subject-rated drug effects of abuse liability
Time frame: 7 hours
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
2 secondary outcomes
Subject-rated drug effects of intoxication
Time frame: 7 hours
Subjective ratings of pain
Time frame: 7 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziva Cooper, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low THC, High THC and Low Myrcene in people with Pain and Abuse, Drug, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia as measured using the Cold Pressor Test (time frame: 7 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.