Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 21 to 45

Sex differences in how cannabis affects people who regularly use it

Official title: The Contribution of the Endocannabinoid System to Sex Differences in THC-associated Reward

Run by Medical University of South Carolina · NCT07815691 · Data updated 2026-11-12

This Phase 2 trial tests whether men and women who use cannabis several days a week respond differently to THC versus placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Ages21 Years to 45 Years
SexAll
Enrollment78 (estimated)
SponsorMedical University of South Carolina
Academic / other
Locations1 site (Charleston, South Carolina)
StatusRecruiting
StartedOctober 1, 2026
Main results expectedJuly 31, 2031
Study endsJuly 31, 2031
Registry record updatedOctober 5, 2026
Trial IDNCT07815691 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 21–45 with DSM-5 cannabis use disorder, regular cannabis use, and willingness to use non-hormonal birth control (for females).

Probably not a fit

Individuals outside the age range, without DSM-5 CUD, or with contraindicated health or pregnancy status may be unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults 21–45 who use cannabis at least four days per week will participate in three in-person visits. The study compares a THC dose to placebo, with questionnaires and a 1-hour brain scan to explore sex differences in effects. One visit includes a blood draw for genetic testing. The design aims to identify sex-specific effects and potential biomarkers while monitoring safety.

Why it matters

Potential benefit: If successful, the study could clarify sex-specific responses to cannabis and inform personalized approaches to treatment or harm reduction.

How similar studies have gone: Previous lines of research suggest biological sex can influence cannabis effects, but this exact design with controlled THC/placebo and neuroimaging is moderately novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Able and willing to provide informed consent
2. Age 21-45
3. Meet DSM-5 criteria for CUD
4. Report cannabis use ≥4 days/week on average in the last 30 days at screening
5. Provide a THC-positive urine sample at screening
6. BMI between 18-30 kg/m2
7. Regular menstrual cycle (females only)
8. Willing to use non-hormonal birth control for the duration of study participation (females only)

Exclusion Criteria:

1. Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder
2. Urinalysis results indicative of recent drug use other than cannabis
3. Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes
4. Current treatment-seeking for CUD or other SUDs
5. Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD
6. Females who are pregnant, nursing, or planning to become pregnant
7. MRI contraindications (e.g., metallic implants, claustrophobia)
8. Significant history of nausea associated with the use of cannabis and/or THC
9. History of cardiac or seizure disorders
10. Allergy to sesame oil

Where it's running

  • Medical University of South Carolina
    Charleston, South Carolina, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.