Exploring cannabis use and stress in young adults
Sex Differences in the Interface Between Cannabis Use and Stress Among Emerging Adults
This study is testing how cannabis affects stress management in young adults with cannabis use disorder to see if a cannabidiol solution can help them cope better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Drugs / interventions | Afatinib, Doxorubicin |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05885542 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between cannabis use and stress, focusing on sex differences among emerging adults with cannabis use disorder. It aims to understand how cannabis affects stress management and coping mechanisms during this critical developmental stage. Participants will receive either a cannabidiol oral solution or a placebo, and their responses will be monitored to inform tailored clinical interventions. The research is grounded in the physiological role of the endocannabinoid system and its development during emerging adulthood.
Who should consider this trial
Good fit: Ideal candidates are emerging adults aged 18-25 who meet the criteria for cannabis use disorder and use cannabis frequently.
Not a fit: Patients who do not meet the criteria for cannabis use disorder or are outside the age range of 18-25 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, sex-specific treatments for cannabis use disorder in young adults.
How similar studies have performed: While there is emerging evidence on sex differences in cannabis use and stress, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kevin M Gray, M.D. — Medical University of South Carolina
- Study coordinator: Kevin Branson
- Email: bransonk@musc.edu
- Phone: 843-792-0493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.