NCT04964739|Completed
Gender/Sex & CUD Remission
Gender and Sex Hormone Influences on Cannabis Use Disorder Remission
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Gender and Sex Hormone Influences on Cannabis Use Disorder Remission
Sponsor study identifier
Secondary identifiers
NIH
interventional
224
1 country
1
Study Start
November 15, 2021
Actual (reported)Primary Completion
October 27, 2025
Actual (reported)Study Completion
October 27, 2025
Actual (reported)Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 27, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2021
Actual (reported)July 16, 2021
Actual (reported)November 15, 2021
Actual (reported)October 27, 2025
Actual (reported)October 27, 2025
Actual (reported)Proportion of participants in remission
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Week 4
Proportion of participants in remission
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Week 8
Proportion of participants in remission
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Week 12
Proportion of participants in remission
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
112 participants identifying as men will be enrolled in 8 weeks of behavioral treatment for cannabis use disorder (CUD). They will receive a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. Gender and hormonal factors will be examined as predictors of CUD remission and cannabis outcomes.
112 participants identifying as women will be enrolled in 8 weeks of behavioral treatment for CUD. They will receive a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. Gender and hormonal factors will be examined as predictors of CUD remission and cannabis outcomes.
Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Rachel L Tomko, PhD
Medical University of South Carolina
Aimee L McRae-Clark, PharmD
Medical University of South Carolina
224 participants (actual enrollment reported by the registry).
First Submitted
July 11, 2021
First Posted
July 16, 2021
Study Start
November 15, 2021
Actual (reported)Cannabis and Processing Emotions Study
Week 16
Proportion of participants in remission
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Week 20
Reduction in cannabis use days
Number of cannabis use days assessed via daily diaries during treatment
8 weeks of treatment
Reduction in cannabis use episodes
Number of cannabis use episodes assessed via daily diaries during treatment
8 weeks of treatment
Contact the study team to confirm eligibility.
Primary Completion
October 27, 2025
Actual (reported)Study Completion
October 27, 2025
Actual (reported)Last Updated
November 10, 2025
Record last verified: 2025-11
Investigators support data sharing as essential for scientific advancement. It is expected that primary outcome papers will be completed and submitted to appropriate peer-reviewed scientific journals within 180 days of data lock. Requests for data from this project by individuals outside of the research team will be reviewed by the team following data lock. Data sharing will adhere to all provisions of the Health Insurance Portability and Accountability Act (HIPAA) and the rights and privacy of people who participate in research will be protected at all times. The requesting Investigator must specify the subset of variables needed or provide a detailed justification of why the complete dataset is absolutely necessary. Data made available to other investigators will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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