Abuse CannabisPhase 1HIGH-CAPNCT06859723
High Potency Cannabis: Acute and Protracted Effects
A Phase 1 study testing Low dose THC and High dose THC in people with Abuse Cannabis 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 effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Abuse Cannabis, Pain, Pharmacokinetics
- What is being tested?
- Low dose THC and High dose THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2025to 1 Jul 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 smoking near daily
- 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)
Who cannot join
- Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine
- Do not have positive urine toxicology for cannabis use during screening
- 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 predominant licit use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
- Current pain
Show all 12Show fewer
- Pregnancy
- 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 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
Vincent Acebo, 310-983-3417, vacebo@mednet.ucla.edu
About this study
The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.
Read the detailed description
This outpatient study will assess the acute pharmacodynamic effects of smoked cannabis with ~50 mg and ~100 mg THC compared to placebo (~0 mg THC) and whether a brief period of abstinence alters these effects. Metabolism (pharmacokinetics) of THC will be examined to associate behavioral and physiological effects to plasma concentrations of THC and metabolites.
- Conditions
- Abuse Cannabis, Pain, Pharmacokinetics
- Being tested
- Placebo Comparator: Placebo, Low dose THC, High dose THC
- Keywords
- THC, Cannabis
- Medical subject headings
- Marijuana Abuse, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Comparator: PlaceboDrug
Also called Cannabis
Placebo
Low dose THCDrug
Also called Cannabis
Smoked low dose THC
High dose THCDrug
Also called Cannabis
Smoked high dose THC
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: Placebo | Placebo comparator | 0 mg THC Receives: Drug: Placebo Comparator: Placebo |
| Low dose THC | Active comparator | 50 mg THC Receives: Drug: Low dose THC |
| High dose THC | Active comparator | 100 mg THC Receives: Drug: High dose THC |
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
Secondary outcomes (2)
Pharmacokinetics of THC and metabolites
Peak plasma levels of THC (ng/ml)
Measured: 3 hours
Pharmacokinetics of THC and metabolites
Peak plasma levels of 11-OH-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 start3 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse CannabisStudies 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
- Collaborators
- California Department of Cannabis Control (DCC)
- Responsible party
- Principal investigator, Ziva D. Cooper, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859723
- Sponsor's protocol ID
- 24-5316
- Other IDs
- 93304
- Acronym
- HIGH-CAP
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2025
- Last updated
- 4 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Potency Cannabis: Acute and Protracted Effects
- ClinicalTrials.gov ID
- NCT06859723
- Acronym / sponsor ID
- HIGH-CAP / 24-5316
- Conditions
- Abuse Cannabis, Pain, Pharmacokinetics
- Keywords
- THC, Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- California Department of Cannabis Control (DCC)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 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 effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.
Detailed description
This outpatient study will assess the acute pharmacodynamic effects of smoked cannabis with ~50 mg and ~100 mg THC compared to placebo (~0 mg THC) and whether a brief period of abstinence alters these effects. Metabolism (pharmacokinetics) of THC will be examined to associate behavioral and physiological effects to plasma concentrations of THC and metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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 Comparator: Placebo | Placebo comparator | Drug: Placebo Comparator: Placebo0 mg THC |
| Low dose THC | Active comparator | Drug: Low dose THC50 mg THC |
| High dose THC | Active comparator | Drug: High dose THC100 mg THC |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Male or non-pregnant and non-lactating females aged 21-55 years
Key exclusion criteria (12 listed)
- Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine
- Do not have positive urine toxicology for cannabis use during screening
- 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 predominant licit use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
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 |
|---|---|---|
| Placebo Comparator: PlaceboAlso: CannabisPlacebo | Drug | Placebo Comparator: Placebo |
| Low dose THCAlso: CannabisSmoked low dose THC | Drug | Low dose THC |
| High dose THCAlso: CannabisSmoked high dose THC | Drug | High dose THC |
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)
2 secondary outcomes
Pharmacokinetics of THC and metabolites
Time frame: 3 hours
Pharmacokinetics of THC and metabolites
Time frame: 3 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 4 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.
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 dose THC and High dose THC in people with Abuse Cannabis 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 6 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: looking for participants now, as of the sponsor's last update on 4 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?
Contact Ziva Cooper, PhD (310-206-9942, cannabislab@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 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 4 Sep 2026.