Abuse, DrugPhase 1THC-REDUXNCT06859710
THC and CBD: A Controlled Human Study Probing a Harm Reduction Strategy
A Phase 1 study testing THC, CBD 20 mg and CBD 40 mg in people with Abuse, Drug and Pain, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this research is to assess the impact of CBD on the effects 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
- Abuse, Drug, Pain
- What is being tested?
- THC, CBD 20 mg and CBD 40 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 1 Sep 2028
- 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 cannabis use 1-7 days per week over the month prior to screening
- Not currently seeking treatment for their cannabis use
- History of inhaled cannabis use
- Have a Body Mass Index from 18.5 - 34 kg/m2
- Able to perform all study procedures
- Must be using a contraceptive (hormonal or barrier methods)
Who cannot join
- Meeting DSM-V criteria for severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, mild or moderate CUD
- Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
- Report using other illicit drugs in the prior 4 weeks
- Current pain
- Pregnancy
- Currently enrolled in another research protocol
Show all 10Show fewer
- 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 as determined by evaluation physician after review of all medical assessments along with medical history.
- Not able to speak and read English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA Center for Cannabis and Cannabinoids
Los Angeles, California, 90095
Ziva D Cooper, PhD, (310) 794 -1497, cannabislab@mednet.ucla.edu
Vince Acebo, vacebo@mednet.ucla.edu
About this study
Official title: Interactions Between Delta-9-THC and CBD: A Controlled Human Drug-administration Study Probing a Harm Reduction Strategy
The purpose of this research is to assess the impact of CBD on the effects of THC.
Read the detailed description
Some evidence indicates that cannabidiol (CBD), a non-intoxicating cannabis component, might mitigate certain effects of THC. This study will examine possible roles for CBD in modulating THC's adverse and analgesic effects.
- Conditions
- Abuse, Drug, Pain
- Being tested
- Placebo, THC, CBD 20 mg, CBD 40 mg, CBD 80 mg
- Keywords
- Cannabis, THC, CBD
- Medical subject headings
- Substance-Related Disorders, Pain, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Cannabis
Vaporized Placebo
THCDrug
Also called Cannabis
Vaporized THC (20 mg)
CBD 20 mgDrug
Also called Cannabis
Vaporized CBD (20 mg)
CBD 40 mgDrug
Also called Cannabis
Vaporized CBD (40 mg)
CBD 80 mgDrug
Also called Cannabis
Vaporized CBD (80 mg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0 mg THC, 0 mg CBD Receives: Drug: Placebo |
| THC | Active comparator | 20 mg THC, 0 mg CBD Receives: Drug: THC |
| CBD 20 | Active comparator | 0 mg THC, 20 mg CBD Receives: Drug: CBD 20 mg |
| CBD 40 | Active comparator | 0 mg THC, 40 mg CBD Receives: Drug: CBD 40 mg |
| CBD 80 | Active comparator | 0 mg THC, 80 mg CBD Receives: Drug: CBD 80 mg |
| THC with CBD 20 | Active comparator | 20 mg THC, 20 mg CBD Receives: Drug: THC; Drug: CBD 20 mg |
| THC with CBD 40 | Active comparator | 20 mg THC, 40 mg CBD Receives: Drug: THC; Drug: CBD 40 mg |
| THC with CBD 80 | Active comparator | 20 mg THC, 80 mg CBD Receives: Drug: THC; Drug: CBD 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-rated drug effects of abuse liability
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
Measured: 3 hours
Analgesia as measured using the Cold Pressor Test
Pain threshold assessed using the Cold Pressor Test (percent baseline)
Measured: 3 hours
Behavioral task performance as assessed by the DRUID App Score
Trough composite scores on the DRUID App
Measured: 3 hours
Pharmacokinetics of THC
Peak plasma levels of THC (ng/ml)
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start5 Nov 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse, DrugStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- 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
- NCT06859710
- Sponsor's protocol ID
- 24-5306
- Other IDs
- 93306
- Acronym
- THC-REDUX
- Status last verified
- Sep 2025
- First submitted
- 25 Feb 2025
- Last updated
- 17 Dec 2025
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Delta-9-THC and CBD: A Controlled Human Drug-administration Study Probing a Harm Reduction Strategy
- ClinicalTrials.gov ID
- NCT06859710
- Acronym / sponsor ID
- THC-REDUX / 24-5306
- Conditions
- Abuse, Drug, Pain
- Keywords
- Cannabis, THC, CBD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Mar 2025 (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 impact of CBD on the effects of THC.
Detailed description
Some evidence indicates that cannabidiol (CBD), a non-intoxicating cannabis component, might mitigate certain effects of THC. This study will examine possible roles for CBD in modulating THC's adverse and analgesic effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- 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 CBD |
| THC | Active comparator | Drug: THC20 mg THC, 0 mg CBD |
| CBD 20 | Active comparator | Drug: CBD 20 mg0 mg THC, 20 mg CBD |
| CBD 40 | Active comparator | Drug: CBD 40 mg0 mg THC, 40 mg CBD |
| CBD 80 | Active comparator | Drug: CBD 80 mg0 mg THC, 80 mg CBD |
| THC with CBD 20 | Active comparator | Drug: THC, Drug: CBD 20 mg20 mg THC, 20 mg CBD |
| THC with CBD 40 | Active comparator | Drug: THC, Drug: CBD 40 mg20 mg THC, 40 mg CBD |
| THC with CBD 80 | Active comparator | Drug: THC, Drug: CBD 80 mg20 mg THC, 80 mg CBD |
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 cannabis use 1-7 days per week over the month prior to screening
- Not currently seeking treatment for their cannabis use
- History of inhaled cannabis use
- Have a Body Mass Index from 18.5 - 34 kg/m2
Key exclusion criteria (10 listed)
- Meeting DSM-V criteria for severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, mild or moderate CUD
- Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
- Report using other illicit drugs in the prior 4 weeks
- Current pain
- Pregnancy
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 |
|---|---|---|
| PlaceboAlso: CannabisVaporized Placebo | Drug | Placebo |
| THCAlso: CannabisVaporized THC (20 mg) | Drug | THC, THC with CBD 20, THC with CBD 40, THC with CBD 80 |
| CBD 20 mgAlso: CannabisVaporized CBD (20 mg) | Drug | CBD 20, THC with CBD 20 |
| CBD 40 mgAlso: CannabisVaporized CBD (40 mg) | Drug | CBD 40, THC with CBD 40 |
| CBD 80 mgAlso: CannabisVaporized CBD (80 mg) | Drug | CBD 80, THC with CBD 80 |
Primary outcome
Subject-rated drug effects of abuse liability
Time frame: 3 hours
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
Analgesia as measured using the Cold Pressor Test
Time frame: 3 hours
Pain threshold assessed using the Cold Pressor Test (percent baseline)
Behavioral task performance as assessed by the DRUID App Score
Time frame: 3 hours
Trough composite scores on the DRUID App
Pharmacokinetics of THC
Time frame: 3 hours
Peak plasma levels of THC (ng/ml)
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 17 Dec 2025.
- 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.
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 THC, CBD 20 mg and CBD 40 mg in people with Abuse, Drug and Pain, 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 10 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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?
Contact Ziva Cooper, PhD (310-206-9942, zcooper@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject-rated drug effects of abuse liability (time frame: 3 hours). The study lists 4 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 17 Dec 2025.