SCORE Emerging Adult Cannabis Use & Stress

NCT05885542 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pro00127995
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Keywords

cannabis; stress; sex; withdrawal

Outcome Measures

Primary Outcomes (3)

• Cannabis withdrawal symptoms

  Cannabis Withdrawal Scale score (Allsop et al., 2011) \[minimum score 0 and maximum score 190; higher score means a worse outcome\]

  Assessed after 3-day cannabis abstinence period

• Stress reactivity

  Within Session Rating Scale - Stress score (Childress et al., 1986) \[minimum score 0 and maximum score 10; higher score means a worse outcome\]

  Measured 5 minutes after laboratory-administered Trier Social Stress Task

• Time to resumption of cannabis use

  After 3-day abstinence phase and laboratory session, ecological momentary assessment will be conducted twice daily for a 10-day span. Participants may resume ad lib cannabis use, and will be prompted to self-report the day/time that they resume cannabis use \[minimum score 0 and maximum score 10 days, with the possibility of no resumption at all; higher score means a better outcome, and no resumption at all by the end of the 10 days is the best possible outcome\]

  Measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days)

Study Arms (2)

cannabidiol 800 mg

EXPERIMENTAL

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

Drug: Cannabidiol oral solution

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cannabidiol oral solution DRUG

Double-blind cannabidiol oral solution 800 mg administered once

cannabidiol 800 mg

Placebo DRUG

Double-blind placebo oral solution administered once

placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse; Coitus

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Kevin M Gray, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Branson

CONTACT

843-792-0493; bransonk@musc.edu

Ashlyn Summersett

CONTACT

843-792-0484; summeash@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization allocation will be completed by statisticians in the Biostatistics Resource Core and all other investigators, study personnel, and participants will be blinded to past and future study allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Model Details: Participants will be randomized to receive either double-blind single-dose CBD 800 mg or matched placebo (1:1) utilizing a stratified random block design. Randomization will be stratified by biological sex (female, male) to facilitate analyses incorporating sex as a biological variable.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: June 2, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)