Endocannabinoids in Reward

Phase 2Not Yet RecruitingNCT07815691

Medical University of South Carolina78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Cannabis Use Disorder

Interventions

DronabinolDRUG

Oral dronabinol capsules (40 mg)

PlaceboDRUG

Matched placebo capsules

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Nucleus accumbens glutamate

Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy

Time frame: 2 hours post-dose

Drug Effects Questionnaire (DEQ) - Like Drug Effect

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.

Time frame: 0-7 hours post-dose

Sex differences in genetics

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

Time frame: Day 1

Secondary Outcomes

Dorsal striatal glutamate

Concentrations of dorsal striatal glutamate measured via proton magnetic resonance spectroscopy

Time frame: 2 hours post-dose

Drug Effects Questionnaire (DEQ) - Want More

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.

Time frame: 0-7 hours post-dose

Drug Effects Questionnaire (DEQ) - High

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.

Time frame: 0-7 hours post-dose

Central Contacts

Erin Martin, Ph.D.

CONTACT

843-876-3528 marterin@musc.edu

Data from ClinicalTrials.gov

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