Recruiting
Phase 1
Phase 2

Cannabis & Stress

Sponsor:

Medical University of South Carolina

Code:

NCT05885542

Conditions

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Cannabidiol oral solution

Placebo

Study Details

Brief 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.

Conditions

Cannabis Use Disorder

Study ID

NCT05885542

Start date

Nov 1, 2023

Status verified date

Nov, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: cannabidiol 800 mg

Cannabidiol 800 mg will be administered orally once in the laboratory prior to a stress induction paradigm.

placebo comparator: placebo

Placebo (formulated to appear identical to active condition) administered orally once in the laboratory prior to a stress induction paradigm.

Interventions

Cannabidiol oral solution

Double-blind cannabidiol oral solution 800 mg administered once

Placebo

Double-blind placebo oral solution administered once

Primary outcome measure

  • Cannabis withdrawal symptoms [ Time Frame: Assessed after 3-day cannabis abstinence period ]
  • Stress reactivity [ Time Frame: Measured 5 minutes after laboratory-administered Trier Social Stress Task ]
  • Time to resumption of cannabis use [ Time Frame: Measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days) ]

Central Contacts and Locations

Central contacts

Kevin Branson

843-792-0493bransonk@musc.edu

Ashlyn Summersett

843-792-0484summeash@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Sarah Bourne

843-876-2084slaggert@musc.edu

Principal Investigator:

Kevin M Gray, M.D.

More Information

Sponsor

Medical University of South Carolina

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • cannabis
  • stress
  • sex
  • withdrawal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-11-05.