Cannabis Use DisorderPhase 1/2NCT05885542
SCORE Emerging Adult Cannabis Use & Stress
A Phase 1/2 study testing Cannabidiol oral solution in people with Cannabis Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Cannabidiol oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Sarah Bourne, 843-876-2084, slaggert@musc.edu
Kevin M Gray, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cannabis Use Disorder
- Being tested
- Cannabidiol oral solution, Placebo
- Keywords
- cannabis, stress, sex, withdrawal
- Medical subject headings
- Marijuana Abuse, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol oral solutionDrug
Double-blind cannabidiol oral solution 800 mg administered once
PlaceboDrug
Double-blind placebo oral solution administered once
| Study group | Role | What they receive |
|---|---|---|
| cannabidiol 800 mg | Experimental | Cannabidiol 800 mg will be administered orally once in the laboratory prior to a stress induction paradigm. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis withdrawal symptoms
Cannabis Withdrawal Scale score (Allsop et al., 2011) [minimum score 0 and maximum score 190; higher score means a worse outcome]
Measured: 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: 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: Measured as the time span from laboratory session to time of resumption of ad lib cannabis use (maximum of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Nov 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Gray, Medical University of South Carolina
- Investigators
- Kevin M Gray, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885542
- Sponsor's protocol ID
- Pro00127995
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2023
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A final de-identified data set will be made available for retrieval and analysis.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in the Interface Between Cannabis Use and Stress Among Emerging Adults
- ClinicalTrials.gov ID
- NCT05885542
- Acronym / sponsor ID
- Pro00127995
- Conditions
- Cannabis Use Disorder
- Keywords
- cannabis, stress, sex, withdrawal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| cannabidiol 800 mg | Experimental | Drug: Cannabidiol oral solutionCannabidiol 800 mg will be administered orally once in the laboratory prior to a stress induction paradigm. |
| placebo | Placebo comparator | Drug: PlaceboPlacebo (formulated to appear identical to active condition) administered orally once in the laboratory prior to a stress induction paradigm. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol oral solutionDouble-blind cannabidiol oral solution 800 mg administered once | Drug | cannabidiol 800 mg |
| PlaceboDouble-blind placebo oral solution administered once | Drug | placebo |
Primary outcome
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]
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]
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Undecided. A final de-identified data set will be made available for retrieval and analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin M Gray, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabidiol oral solution in people with Cannabis Use Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Branson (843-792-0493, bransonk@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis withdrawal symptoms (time frame: Assessed after 3-day cannabis abstinence period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.