PainPhase 1SAGENCT05865470
Age-dependent Effects of Smoked and Oral Delta-9-THC
A Phase 1 study testing Cannabis and Dronabinol in people with Pain and Abuse, Drug, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Abuse, Drug, Intoxication; Cannabinoids
- What is being tested?
- Cannabis and Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to 15 Oct 2029
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year)
- Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
- Not currently seeking treatment for their cannabis use
- No reported clinically significant adverse effects with cannabis use
- Have a Body Mass Index from 18.5 - 34kg/m2
- Able to perform all study procedures
- FEMALES: Currently practicing an effective form of birth control if pre-menopausal
Who cannot join
- Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
- Report using other illicit drugs in the prior 4 weeks
- Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) 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.
- Current predominant licit use of medical cannabis
- Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
- 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
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- Current pain
- Pregnancy is exclusionary due to the possible effects of the study medication on fetal development
- History of an allergic reaction or adverse reaction to cannabis is exclusionary.
- Currently enrolled in another research protocol
- 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.
- Intolerance to lactose and sesame (ingredients in the oral THC preparation)
- Insensitivity to the Cold Pressor Test
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: Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC
This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.
Read the detailed description
The overall objective of this placebo-controlled, outpatient study is to compare the dose-dependent effects of smoked and oral THC on analgesia and endpoints directly related to adverse consequences of use including abuse liability, intoxication, and impairment as a function of age and sex.
- Conditions
- Pain, Abuse, Drug, Intoxication; Cannabinoids
- Being tested
- Cannabis, Dronabinol, Smoked Placebo, Oral Placebo
- Keywords
- Pain, Cannabis, Delta-9-THC, Age, Sex
- Medical subject headings
- Pain, Substance-Related Disorders, Marijuana Abuse, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called Smoked cannabis with THC
smoked cannabis
DronabinolDrug
Also called Delta-9-THC
Oral delta-9-THC
Smoked PlaceboDrug
Also called Placebo smoked cannabis (no THC)
Placebo Cannabis
Oral PlaceboDrug
Oral Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: Placebo | Placebo comparator | Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC) Receives: Drug: Smoked Placebo; Drug: Oral Placebo |
| Experimental: Low strength cannabis | Experimental | Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC) Receives: Drug: Cannabis; Drug: Oral Placebo |
| Experimental: Higher strength cannabis | Experimental | Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC) Receives: Drug: Cannabis; Drug: Oral Placebo |
| Experimental: Low strength oral THC | Experimental | Smoked Cannabis (0 mg THC) Oral THC (10 mg THC) Receives: Drug: Dronabinol; Drug: Smoked Placebo |
| Experimental: Higher strength oral THC | Experimental | Smoked Cannabis (0 mg THC) Oral THC (20 mg THC) Receives: Drug: Dronabinol; Drug: Smoked Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-rated drug effects
Average and peak subjective ratings of drug effects associated with abuse liability and intoxication as measured using visual analogue scales (VAS; 1-100mm).
Measured: 6 hours
Analgesia as measured using the Cold Pressor Test
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Measured: 6 hours
Impairment
The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
Measured: 6 hours
Pharmacokinetics of THC and metabolites
Plasma levels of THC, 11-OH-THC, and THCCOOH
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start30 Apr 2025
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2029 (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
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- 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
- NCT05865470
- Sponsor's protocol ID
- 22-001292
- Other IDs
- R01DA057252
- Acronym
- SAGE
- Status last verified
- Jan 2026
- First submitted
- 9 May 2023
- Last updated
- 7 Jan 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC
- ClinicalTrials.gov ID
- NCT05865470
- Acronym / sponsor ID
- SAGE / 22-001292
- Conditions
- Pain, Abuse, Drug, Intoxication; Cannabinoids
- Keywords
- Pain, Cannabis, Delta-9-THC, Age, Sex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Oct 2029 (estimated)
- First posted
- 18 May 2023 (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 age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.
Detailed description
The overall objective of this placebo-controlled, outpatient study is to compare the dose-dependent effects of smoked and oral THC on analgesia and endpoints directly related to adverse consequences of use including abuse liability, intoxication, and impairment as a function of age and sex.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- 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: Smoked Placebo, Drug: Oral PlaceboSmoked Cannabis (0 mg THC) Oral placebo (0 mg THC) |
| Experimental: Low strength cannabis | Experimental | Drug: Cannabis, Drug: Oral PlaceboSmoked Cannabis (10 mg THC) Oral placebo (0 mg THC) |
| Experimental: Higher strength cannabis | Experimental | Drug: Cannabis, Drug: Oral PlaceboSmoked Cannabis (20 mg THC) Oral placebo (0 mg THC) |
| Experimental: Low strength oral THC | Experimental | Drug: Dronabinol, Drug: Smoked PlaceboSmoked Cannabis (0 mg THC) Oral THC (10 mg THC) |
| Experimental: Higher strength oral THC | Experimental | Drug: Dronabinol, Drug: Smoked PlaceboSmoked Cannabis (0 mg THC) Oral THC (20 mg THC) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year)
- Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
- Not currently seeking treatment for their cannabis use
- No reported clinically significant adverse effects with cannabis use
- Have a Body Mass Index from 18.5 - 34kg/m2
Key exclusion criteria (14 listed)
- Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
- Report using other illicit drugs in the prior 4 weeks
- Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) 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.
- Current predominant licit use of medical cannabis
- Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
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 |
|---|---|---|
| CannabisAlso: Smoked cannabis with THCsmoked cannabis | Drug | Experimental: Higher strength cannabis, Experimental: Low strength cannabis |
| DronabinolAlso: Delta-9-THCOral delta-9-THC | Drug | Experimental: Higher strength oral THC, Experimental: Low strength oral THC |
| Smoked PlaceboAlso: Placebo smoked cannabis (no THC)Placebo Cannabis | Drug | Experimental: Higher strength oral THC, Experimental: Low strength oral THC, Placebo Comparator: Placebo |
| Oral PlaceboOral Placebo | Drug | Experimental: Higher strength cannabis, Experimental: Low strength cannabis, Placebo Comparator: Placebo |
Primary outcome
Subject-rated drug effects
Time frame: 6 hours
Average and peak subjective ratings of drug effects associated with abuse liability and intoxication as measured using visual analogue scales (VAS; 1-100mm).
Analgesia as measured using the Cold Pressor Test
Time frame: 6 hours
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Impairment
Time frame: 6 hours
The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
Pharmacokinetics of THC and metabolites
Time frame: 6 hours
Plasma levels of THC, 11-OH-THC, and THCCOOH
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 7 Jan 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.
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 Cannabis and Dronabinol 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: looking for participants now, as of the sponsor's last update on 7 Jan 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 D Cooper, PhD (310-983-3417, 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 (time frame: 6 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 7 Jan 2026.