PainPhase 1ASCENTNCT04859296
AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT)
A Phase 1 study testing Low CBG, High CBG and Low THC in people with Pain and Appetite Loss, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with 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, Appetite Loss, Abuse, Drug
- What is being tested?
- Low CBG, High CBG and Low THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 4 Dec 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 and non-lactating females aged 21-55 years
- • Report occasional use of cannabis (cannabis use between ≥ biweekly and ≤ 3 days per week) over the month prior to screening
- Not currently seeking treatment for their cannabis use
- Have a Body Mass Index from 18.5 - 34kg/m2.
- Able to perform all study procedures
- Must be using a contraceptive (hormonal or barrier methods)
- Females must not be lactating
Who cannot join
- Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, or mild CUD
- Any other Axis I disorder
- • Current use of any medications within 14 days or 5 half-lives of administration (whichever is longer) except for hormonal contraceptives in females. If a medication is taken once a participant is enrolled, sessions will be suspended for 14 days or 5 half-lives after administration (whichever is longer)
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are 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 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
- Currently enrolled in another research protocol
- Not using a contraceptive method (hormonal or barrier methods)
- Insensitivity to the cold water stimulus of the Cold Pressor Test
- Any disorders that might make cannabis administration hazardous are exclusionary, as determined by the evaluating physician
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 Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol
This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.
Read the detailed description
The overall aim of this double-blind, placebo-controlled, within-subject study in healthy, occasional cannabis smokers is to ascertain the dose-dependent analgesic and appetite-stimulating effects of ecologically relevant doses of cannabigerol (CBG) alone and in combination with a sub-analgesic / sub-appetite stimulating, minimally psychoactive dose of THC and an analgesic, appetite-stimulating, but intoxicating dose of THC.
- Conditions
- Pain, Appetite Loss, Abuse, Drug
- Being tested
- Placebo, Low CBG, High CBG, Low THC, High THC
- Keywords
- Analgesia, Pain, Appetite, THC, Cannabigerol, CBG
- Medical subject headings
- Pain, Anorexia, Substance-Related Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Vaporized placebo
Low CBGDrug
Vaporized CBG (5 mg)
High CBGDrug
Vaporized CBG (15 mg)
Low THCDrug
Vaporized THC (5 mg)
High THCDrug
Vaporized THC (15 mg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0 mg CBG, 0 mg THC Receives: Drug: Placebo |
| Low strength CBG | Active comparator | 5 mg CBG, 0 mg THC Receives: Drug: Low CBG |
| High strength CBG | Active comparator | 15 mg CBG, 0 mg THC Receives: Drug: High CBG |
| Low strength THC | Active comparator | 0 mg CBG, 5 mg THC Receives: Drug: Low THC |
| High strength THC | Active comparator | 0 mg CBG, 30 mg THC Receives: Drug: High THC |
| Low strength CBG + Low strength THC | Active comparator | 5 mg CBG + 5 mg THC Receives: Drug: Low CBG; Drug: Low THC |
| Low strength CBG + High strength THC | Active comparator | 5 mg CBG + 15 mg THC Receives: Drug: Low CBG; Drug: High THC |
| High strength CBG + Low strength THC | Active comparator | 15 mg CBG + 5 mg THC Receives: Drug: High CBG; Drug: Low THC |
| High strength CBG + High strength THC | Active comparator | 15 mg CBG + 15 mg THC Receives: Drug: High CBG; Drug: High THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia
Pain threshold and pain tolerance assessed with the Cold Pressor Test - time to report first feeling pain (0-180 seconds) and remove the hand from the cold water (0-180 seconds). Increased duration means increased pain tolerance and pain threshold.
Measured: 7 hours
Appetite stimulation
Subjective ratings of hunger assessed with a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of hunger / appetite stimulation.
Measured: 7 hours
Abuse liability
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of abuse liability.
Measured: 7 hours
Secondary outcomes (2)
Subjective ratings of intoxication
Subject ratings of "High" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of intoxication.
Measured: 7 hours
Subjective ratings of pain
Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test. Scale is from 0 (Not painful / bothersome at all) to 10 (The most painful / bothersome feeling imaginable), higher ratings indicate greater painfulness and bothersomeness.
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 posted26 Apr 2021
- Study start15 Feb 2023
- Primary completion4 Dec 2025
- Study completion4 Dec 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Medicinal Cannabis Research
- Responsible party
- Principal investigator, Ziva D. Cooper, PhD, University of California, Los Angeles
- Investigators
- Ziva D Cooper, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859296
- Sponsor's protocol ID
- 21-000208
- Acronym
- ASCENT
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2021
- Last updated
- 20 Mar 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol
- ClinicalTrials.gov ID
- NCT04859296
- Acronym / sponsor ID
- ASCENT / 21-000208
- Conditions
- Pain, Appetite Loss, Abuse, Drug
- Keywords
- Analgesia, Pain, Appetite, THC, Cannabigerol, CBG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Center for Medicinal Cannabis Research
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2026 (estimated)
- First posted
- 26 Apr 2021 (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.
This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.
Detailed description
The overall aim of this double-blind, placebo-controlled, within-subject study in healthy, occasional cannabis smokers is to ascertain the dose-dependent analgesic and appetite-stimulating effects of ecologically relevant doses of cannabigerol (CBG) alone and in combination with a sub-analgesic / sub-appetite stimulating, minimally psychoactive dose of THC and an analgesic, appetite-stimulating, but intoxicating dose of THC.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- 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 CBG, 0 mg THC |
| Low strength CBG | Active comparator | Drug: Low CBG5 mg CBG, 0 mg THC |
| High strength CBG | Active comparator | Drug: High CBG15 mg CBG, 0 mg THC |
| Low strength THC | Active comparator | Drug: Low THC0 mg CBG, 5 mg THC |
| High strength THC | Active comparator | Drug: High THC0 mg CBG, 30 mg THC |
| Low strength CBG + Low strength THC | Active comparator | Drug: Low CBG, Drug: Low THC5 mg CBG + 5 mg THC |
| Low strength CBG + High strength THC | Active comparator | Drug: Low CBG, Drug: High THC5 mg CBG + 15 mg THC |
| High strength CBG + Low strength THC | Active comparator | Drug: High CBG, Drug: Low THC15 mg CBG + 5 mg THC |
| High strength CBG + High strength THC | Active comparator | Drug: High CBG, Drug: High THC15 mg CBG + 15 mg THC |
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 and non-lactating females aged 21-55 years
- • Report occasional use of cannabis (cannabis use between ≥ biweekly and ≤ 3 days per week) over the month prior to screening
- Not currently seeking treatment for their cannabis use
- Have a Body Mass Index from 18.5 - 34kg/m2.
- Able to perform all study procedures
Key exclusion criteria (12 listed)
- Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, or mild CUD
- Any other Axis I disorder
- • Current use of any medications within 14 days or 5 half-lives of administration (whichever is longer) except for hormonal contraceptives in females. If a medication is taken once a participant is enrolled, sessions will be suspended for 14 days or 5 half-lives after administration (whichever is longer)
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are 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 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 |
|---|---|---|
| PlaceboVaporized placebo | Drug | Placebo |
| Low CBGVaporized CBG (5 mg) | Drug | Low strength CBG, Low strength CBG + High strength THC, Low strength CBG + Low strength THC |
| High CBGVaporized CBG (15 mg) | Drug | High strength CBG, High strength CBG + High strength THC, High strength CBG + Low strength THC |
| Low THCVaporized THC (5 mg) | Drug | High strength CBG + Low strength THC, Low strength CBG + Low strength THC, Low strength THC |
| High THCVaporized THC (15 mg) | Drug | High strength CBG + High strength THC, High strength THC, Low strength CBG + High strength THC |
Primary outcome
Analgesia
Time frame: 7 hours
Pain threshold and pain tolerance assessed with the Cold Pressor Test - time to report first feeling pain (0-180 seconds) and remove the hand from the cold water (0-180 seconds). Increased duration means increased pain tolerance and pain threshold.
Appetite stimulation
Time frame: 7 hours
Subjective ratings of hunger assessed with a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of hunger / appetite stimulation.
Abuse liability
Time frame: 7 hours
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of abuse liability.
2 secondary outcomes
Subjective ratings 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 20 Mar 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 D 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 CBG, High CBG and Low THC in people with Pain and Appetite Loss, 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 12 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 20 Mar 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 (time frame: 7 hours). The study lists 3 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 20 Mar 2026.