SCORE Emerging Adult Cannabis Use & Stress

• Status: Not yet recruiting
• Trial end date: 2028-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The interface between cannabis use and stress is a particularly important focus for sex differences research in emerging adults. Given the dynamics at play in this critical stage when cannabis use is most prevalent, developmentally informed research is needed to guide tailored clinical interventions. This study will apply rigorous and innovative methods to elucidate sex differences in the nexus of cannabis use and stress among emerging adults with cannabis use disorder to guide the development of tailored treatments.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

• Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments

• Meet DSM-5 criteria for CUD and report using cannabis at least five times weekly over the past month. While individuals may also meet criteria for other mild substance use disorders, they must identify cannabis as their primary substance

• Age 18-25

• BMI between 18-30 (to decrease variability in CBD response and in endocannabinoid system measures)

• AST, ALT, and total bilirubin within the laboratory reference range of normal

• Consent to alcohol abstinence for 12 hours prior to study visits, three days of cannabis abstinence as part of study procedures, and abstinence from all substances aside from cannabis, alcohol, and nicotine for the duration of the study

• Sexually active females of childbearing potential must agree to utilize an effective means of birth control.

• Consent to random assignment to CBD versus placebo

Exclusion Criteria:

• Females who are pregnant, nursing, or planning to become pregnant during the study.

• Current moderate or severe substance use disorder other than cannabis

• Current medications or supplements with clinically significant interactions with cannabidiol (per Lexicomp, this list includes Blasting, Doxorubicin, Mavacamten, Pazopanib, Sirolimus, Topotecan, Vincristine, Afatinib, Berotraslstat, Cilostazol, Citalopram, Colchicine, Digoxin, Lefamulin, Relugolix, Relugolix+Estradiol+Norethindrone, Rimegepant, Tizanidine, Ubrogepant, and Venetoclax in the categories of "avoid combination" or "consider therapy modification")

• Current unstable psychiatric or medical disorder that would interfere with safety, compromise data integrity, or preclude reliable participation

• History of hypersensitivity to CBD, sesame, or sesame products

• Inability to comply with study procedures