Gender/Sex & CUD Remission

Gender and Sex Hormone Influences on Cannabis Use Disorder Remission

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.

Study Overview

• Status: Recruiting
• Conditions: Cannabis Use Disorder, Mild; Cannabis Use Disorder, Moderate; Cannabis Use Disorder, Severe
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT4CBT)

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Program Coordinator; Phone Number: 843-792-0493; Email: bransonk@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Program Coordinator; Phone Number: 843-792-0493; Email: bransonk@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willingness to participate in a research study (otherwise, will be referred to appropriate clinical services if seeking clinical care).
2. Meet current (within last 30 days) DSM-5 criteria for cannabis use disorder.
3. Submit a positive urine cannabinoid test during screening.
4. Interested in treatment for cannabis use disorder.

Exclusion Criteria:

1. Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation.
2. The presence of any substance use disorder requiring a higher level of care.
3. Significant risk of homicide or suicide.
4. Pregnant, trying to become pregnant, or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cognitive Behavioral Therapy - Men; 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.	Behavioral: Cognitive Behavioral Therapy (CBT4CBT); Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT.
Other: Cognitive Behavioral Therapy - Women; 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.	Behavioral: Cognitive Behavioral Therapy (CBT4CBT); Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Rachel L Tomko, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Anticipated): March 31, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Marijuana Abuse
• Other Study ID Numbers: 00110801; R01DA054617 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No