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NCT Number: NCT07815691

Endocannabinoids in Reward

This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1-hour brain scan. One visit will also include a blood draw for genetic testing.

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Key information

Conditions

Cannabis Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dronabinol

Drug

Oral dronabinol capsules (40 mg)

Other names: Marinol

Placebo

Drug

Matched placebo capsules

Primary outcomes

  1. Nucleus accumbens glutamate

    Time frame: 2 hours post-dose

    Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy

  2. Drug Effects Questionnaire (DEQ) - Like Drug Effect

    Time frame: 0-7 hours post-dose

    Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.

  3. Sex differences in genetics

    Time frame: Day 1

    Blood-based DNA sample will be tested for genetic variants of interest involved in the endocannabinoid system

Secondary outcomes

  1. Dorsal striatal glutamate

    Time frame: 2 hours post-dose

    Concentrations of dorsal striatal glutamate measured via proton magnetic resonance spectroscopy

  2. Drug Effects Questionnaire (DEQ) - Want More

    Time frame: 0-7 hours post-dose

    Visual Analog Scale rating of subjective desire for more of the same drug included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.

  3. Drug Effects Questionnaire (DEQ) - High

    Time frame: 0-7 hours post-dose

    Visual Analog Scale rating of subjective "high" included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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