SCORE Emerging Adult Cannabis Use & Stress
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ClinicalTrials.gov Identifier: NCT05885542 |
Recruitment Status :
Recruiting
First Posted : June 2, 2023
Last Update Posted : November 18, 2023
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Condition or disease | Intervention/treatment | Phase |
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Cannabis Use Disorder | Drug: Cannabidiol oral solution Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 148 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Sex Differences in the Interface Between Cannabis Use and Stress Among Emerging Adults |
Actual Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | July 31, 2028 |
Estimated Study Completion Date : | July 31, 2028 |
Arm | Intervention/treatment |
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Experimental: cannabidiol 800 mg
Cannabidiol 800 mg will be administered orally once in the laboratory prior to a stress induction paradigm.
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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.
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Drug: Placebo
Double-blind placebo oral solution administered once |
- 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]
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Ages Eligible for Study: | 18 Years to 25 Years (Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | All |
Accepts Healthy Volunteers: | No |
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 moderate or 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05885542
Contact: Kevin Branson | 843-792-0493 | bransonk@musc.edu | |
Contact: Ashlyn Summersett | 843-792-0484 | summeash@musc.edu |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Danielle Slaggert 843-792-4815 slaggert@musc.edu | |
Contact: Sarah Bourne 843-876-2084 bourne@musc.edu | |
Principal Investigator: Kevin M Gray, M.D. |
Principal Investigator: | Kevin M Gray, M.D. | Medical University of South Carolina |
Responsible Party: | Kevin Gray, MD, Professor-Faculty, Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT05885542 |
Other Study ID Numbers: |
Pro00127995 |
First Posted: | June 2, 2023 Key Record Dates |
Last Update Posted: | November 18, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | A final de-identified data set will be made available for retrieval and analysis. |
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 |
cannabis stress sex withdrawal |
Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders |
Mental Disorders Cannabidiol Anticonvulsants |