SCORE Emerging Adult Cannabis Use & Stress

November 3, 2025 updated by: Kevin Gray, Medical University of South Carolina

Sex Differences in the Interface Between Cannabis Use and Stress Among Emerging Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Among the physiological systems most important to brain development in emerging adulthood is the endocannabinoid system, which among other roles facilitates cognitive and behavioral processing, including the underpinnings of stress management and resiliency. Sex differences in endocannabinoid system development have been identified, and emerging evidence indicates a bidirectional relationship between stress exposure and the endocannabinoid system during emerging adulthood. Repeated exposure to exogenous cannabinoids, such as those administered via cannabis use, perturbates endocannabinoid system development, which may adversely affect the programming of future coping in a manner that differs by sex. Use of cannabis, which exerts its psychoactive effects via delta-9-tetrahydrocannabinol binding to endocannabinoid receptors, is more common among emerging adults than in any other age group. Many regular users develop a maladaptive, impairing pattern of use characterized as cannabis use disorder (CUD). A constellation of preliminary evidence suggests several factors disproportionately complicate CUD in females compared to males; the salience of these factors in emerging adulthood indicates that this developmental stage deserves focused sex differences research to inform clinical management. A central running thread is the importance of stress and stress-reactivity across endocannabinoid system development, cannabis use, CUD, cannabis withdrawal, and relapse to cannabis use. This study combines rigorous ecological momentary assessment (EMA), controlled human laboratory procedures, and innovative bioassay collection. Emerging adult cannabis users with CUD (ages 18-25, N=148, 1:1 female to male ratio) will undergo 3 days of reinforced abstinence with EMA monitoring of cannabis withdrawal and stress-related symptoms, followed by a standardized laboratory stress induction paradigm. Blood levels of endocannabinoid system markers will be assessed before and after the abstinence period; during the lab session, self-report measures and biomarkers of stress reactivity will be collected. Double-blind cannabidiol (CBD) versus placebo dosing before the laboratory stress paradigm will allow for examination of effects on stress response during withdrawal. Prior work indicates CBD administration reduces stress response in general populations and preliminary research suggests this effect may extend to cannabis users; this has not been rigorously applied to induced stress amid cannabis withdrawal in emerging adults with CUD, a context particularly important for females with CUD who often report using cannabis to cope with stress. Following the laboratory session, EMA monitoring will resume as participants return to ad libitum cannabis use, providing the opportunity to test associations between stress reactivity and time to resumption of use. The proposed study is designed to elucidate sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Kevin M Gray, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cannabidiol 800 mg
Cannabidiol 800 mg will be administered orally once in the laboratory prior to a stress induction paradigm.
Drug: Cannabidiol oral solution
Double-blind cannabidiol oral solution 800 mg administered once
Placebo Comparator: placebo
Placebo (formulated to appear identical to active condition) administered orally once in the laboratory prior to a stress induction paradigm.
Drug: Placebo
Double-blind placebo oral solution administered once

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cannabis withdrawal symptoms
Time Frame: Assessed after 3-day cannabis abstinence period
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
Time Frame: Measured 5 minutes after laboratory-administered Trier Social Stress Task
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
Time Frame: Measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin M Gray, M.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00127995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A final de-identified data set will be made available for retrieval and analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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