Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT07279558
Description:
Investigators will submit all de-identified individual level phenotypic human subjects data from this project to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive, which is part of the National Institutes of Mental Health (NIMH) Data Archive (NDA).
The project also involves collection of human specimens (fecal samples) which will generate non-human genomic data. Specifically, investigators plan to generate 360 (180 subjects x 2 timepoints) human gut microbiota metagenomes (i.e., gut microbiome). Deidentified genomic data (microbiome sequencing from the fecal samples) will be uploaded to the appropriate data repository upon NIH program administrator determination (NDA or the database of Genotypes and Phenotypes \[dbGaP\]).
Participants will be given the option in the consent/HIPAA form to allow the use of any leftover samples to bank for future undetermined analyses not specified in the protocol.
Study:
NCT07279558
Study Brief:
Cannabidiol and Alcohol Use Disorder Phenotypes