PainPhase 1CanSexNCT04385082
Cannabis Effects as a Function of Sex
A Phase 1 study testing Active Cannabis 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 impact of cannabis on the analgesic and abuse-related effects between men and women 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?
- Active Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2021to 30 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 use of cannabis an average of 1-7 days per week
- Not currently seeking treatment for their cannabis use
- Urine test positive for recent cannabis use for heavy users
- No reported adverse effects with cannabis smoking in light users
- Have a Body Mass Index from 18.5 - 34kg/m2.
Show all 9Show fewer
- Able to perform all study procedures
- FEMALES: Currently practicing a non-hormonal effective form of birth control
- FEMALES: Must be regularly cycling
Who cannot join
- Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder
- Report using other illicit drugs in the prior 4 weeks
- History or current evidence of severe psychiatric illness or medical condition 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 use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
- Current pain
- Insensitivity to the cold water stimulus of the Cold Pressor Test
- FEMALES: using a hormonal contraceptive
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: Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women
Read the detailed description
The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.
- Conditions
- Pain, Abuse, Drug
- Being tested
- Active Cannabis, Placebo Cannabis
- Keywords
- Pain, Cannabis, THC
- Medical subject headings
- Pain, Substance-Related Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CannabisDrug
Smoked cannabis with THC
Placebo CannabisDrug
Placebo smoked cannabis (no THC)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Smoked Cannabis (~0% THC) Receives: Drug: Placebo Cannabis |
| Low strength cannabis | Experimental | Smoked Cannabis (~4% THC) Receives: Drug: Active Cannabis |
| Higher strength cannabis | Experimental | Smoked Cannabis (~10% THC) Receives: Drug: Active Cannabis |
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 as measured using visual analogue scales (VAS; 1-100mm).
Measured: 5 hours
Analgesia as measured using the Cold Pressor Test
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Measured: 5 hours
Pharmacokinetics of THC and metabolites
Plasma levels of THC, 11-OH-THC, and THCCOOH
Measured: 5 hours
Secondary outcomes (1)
Drug reinforcement using the cannabis self-administration task
Average number of cannabis puffs self-administered as a function of cannabis strength and sex. For this task, up to three 'puffs' of cannabis may be chosen for self-administration during each session.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start8 Jul 2021
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 161 participants (actual)
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
- NCT04385082
- Sponsor's protocol ID
- 19-000876
- Other IDs
- R01DA047296
- Acronym
- CanSex
- Status last verified
- Oct 2026
- First submitted
- 7 May 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pabon E, Baglot SL, Eversole A, Fong T, Hampilos K, Hilger A, Lake S, Murray CH, Arout CA, Haney M, Tran A, Torrens A, Piomelli D, Cooper ZD. Cannabis use patterns and perception of acute pain during brief abstinence: sex-dependent associations with circulating cannabinoid levels. Psychopharmacology (Berl). 2026 Apr 21:10.1007/s00213-026-07063-2. doi: 10.1007/s00213-026-07063-2. Online ahead of print.
PubMed 42009751
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
- ClinicalTrials.gov ID
- NCT04385082
- Acronym / sponsor ID
- CanSex / 19-000876
- Conditions
- Pain, Abuse, Drug
- Keywords
- Pain, Cannabis, THC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 12 May 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 impact of cannabis on the analgesic and abuse-related effects between men and women
Detailed description
The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.
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 | Placebo comparator | Drug: Placebo CannabisSmoked Cannabis (~0% THC) |
| Low strength cannabis | Experimental | Drug: Active CannabisSmoked Cannabis (~4% THC) |
| Higher strength cannabis | Experimental | Drug: Active CannabisSmoked Cannabis (~10% THC) |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or non-pregnant female aged 21-55 years
- Report use of cannabis an average of 1-7 days per week
- Not currently seeking treatment for their cannabis use
- Urine test positive for recent cannabis use for heavy users
- No reported adverse effects with cannabis smoking in light users
Key exclusion criteria (7 listed)
- Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder
- Report using other illicit drugs in the prior 4 weeks
- History or current evidence of severe psychiatric illness or medical condition 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 use of medical cannabis, 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 |
|---|---|---|
| Active CannabisSmoked cannabis with THC | Drug | Higher strength cannabis, Low strength cannabis |
| Placebo CannabisPlacebo smoked cannabis (no THC) | Drug | Placebo |
Primary outcome
Subject-rated drug effects
Time frame: 5 hours
Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Analgesia as measured using the Cold Pressor Test
Time frame: 5 hours
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Pharmacokinetics of THC and metabolites
Time frame: 5 hours
Plasma levels of THC, 11-OH-THC, and THCCOOH
1 secondary outcome
Drug reinforcement using the cannabis self-administration task
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 42009751Pabon E, Baglot SL, Eversole A, Fong T, Hampilos K, Hilger A, Lake S, Murray CH, Arout CA, Haney M, Tran A, Torrens A, Piomelli D, Cooper ZD. Cannabis use patterns and perception of acute pain during brief abstinence: sex-dependent associations with circulating cannabinoid levels. Psychopharmacology (Berl). 2026 Apr 21:10.1007/s00213-026-07063-2. doi: 10.1007/s00213-026-07063-2. Online ahead of print.
- 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 Active Cannabis 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 27 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject-rated drug effects (time frame: 5 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?
On the ClinicalTrials.gov record for NCT04385082, which also lists 1 linked publication.
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 27 Oct 2026.