CannabisPhase 1THC-GenderNCT02781519
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
A Phase 1 study testing THC in people with Cannabis, run by Yale University at 1 site in United States.
Trial summary
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- THC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least one lifetime exposure to cannabis
- good physical and mental health
Who cannot join
- cannabis naive individuals
- major current or recent stressors
- taking estrogen supplements or oral contraceptive pills (for women)
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
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, 06516
Christina Luddy, BS, 203-932-5711 ext. 4549, christina.luddy@yale.edu
About this study
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.
- Conditions
- Cannabis
- Being tested
- THC, Placebo
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
Also called Delta-9-Tetrahydrocannabinol
Active THC (0.015mg/kg) administered over 10 minutes
PlaceboDrug
Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| THC | Active comparator | Active THC (0.015mg/kg) administered intravenously over 10 minutes. Receives: Drug: THC |
| Placebo | Placebo comparator | Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rewarding Effects measured by Visual Analog Scale (VAS)
subjective measure of THC induced "high"
Measured: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins
Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT)
measured as delay recall on the AVLT
Measured: 25 minutes after THC infusion begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
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 CannabisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohini Ranganathan, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781519
- Sponsor's protocol ID
- 1505015940
- Acronym
- THC-Gender
- Status last verified
- Jun 2025
- First submitted
- 16 May 2016
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mohammad Aghaei A, Urban Spillane L, Pittman B, Flynn LT, De Aquino JP, Bassir Nia A, Ranganathan M. Sex differences in the acute effects of oral THC: a randomized, placebo-controlled, crossover human laboratory study. Psychopharmacology (Berl). 2024 Oct;241(10):2145-2155. doi: 10.1007/s00213-024-06625-6. Epub 2024 Jun 4.
PubMed 38832949
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
- ClinicalTrials.gov ID
- NCT02781519
- Acronym / sponsor ID
- THC-Gender / 1505015940
- Conditions
- Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 May 2016 (estimated)
- 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 the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THC | Active comparator | Drug: THCActive THC (0.015mg/kg) administered intravenously over 10 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboControl: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- at least one lifetime exposure to cannabis
- good physical and mental health
Key exclusion criteria (3 listed)
- cannabis naive individuals
- major current or recent stressors
- taking estrogen supplements or oral contraceptive pills (for women)
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 |
|---|---|---|
| THCAlso: Delta-9-TetrahydrocannabinolActive THC (0.015mg/kg) administered over 10 minutes | Drug | THC |
| PlaceboControl: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes | Drug | Placebo |
Primary outcome
Rewarding Effects measured by Visual Analog Scale (VAS)
Time frame: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins
subjective measure of THC induced "high"
Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT)
Time frame: 25 minutes after THC infusion begins
measured as delay recall on the AVLT
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 10 Jun 2025.
- Derived from this study: PubMed 38832949Mohammad Aghaei A, Urban Spillane L, Pittman B, Flynn LT, De Aquino JP, Bassir Nia A, Ranganathan M. Sex differences in the acute effects of oral THC: a randomized, placebo-controlled, crossover human laboratory study. Psychopharmacology (Berl). 2024 Oct;241(10):2145-2155. doi: 10.1007/s00213-024-06625-6. Epub 2024 Jun 4.
- 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 THC in people with Cannabis, run by Yale University 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 2 inclusion and 3 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 10 Jun 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 Christina Luddy, BS (203-932-5711 ext. 4549, christina.luddy@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rewarding Effects measured by Visual Analog Scale (VAS) (time frame: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins). 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?
On the ClinicalTrials.gov record for NCT02781519, 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 10 Jun 2025.