search
Back to results

Gender/Sex & CUD Remission

Primary Purpose

Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT4CBT)
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis Use Disorder, Mild

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cognitive Behavioral Therapy - Men

Cognitive Behavioral Therapy - Women

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Reduction in cannabis use days
Number of cannabis use days assessed via daily diaries during treatment
Reduction in cannabis use episodes
Number of cannabis use episodes assessed via daily diaries during treatment

Secondary Outcome Measures

Full Information

First Posted
July 11, 2021
Last Updated
November 28, 2022
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04964739
Brief Title
Gender/Sex & CUD Remission
Official Title
Gender and Sex Hormone Influences on Cannabis Use Disorder Remission
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy - Men
Arm Type
Other
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy - Women
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT4CBT)
Intervention Description
Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT.
Primary Outcome Measure Information:
Title
Proportion of participants in remission
Description
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Time Frame
Week 4
Title
Proportion of participants in remission
Description
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Time Frame
Week 8
Title
Proportion of participants in remission
Description
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Time Frame
Week 12
Title
Proportion of participants in remission
Description
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Time Frame
Week 16
Title
Proportion of participants in remission
Description
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview.
Time Frame
Week 20
Title
Reduction in cannabis use days
Description
Number of cannabis use days assessed via daily diaries during treatment
Time Frame
8 weeks of treatment
Title
Reduction in cannabis use episodes
Description
Number of cannabis use episodes assessed via daily diaries during treatment
Time Frame
8 weeks of treatment

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willingness to participate in a research study (otherwise, will be referred to appropriate clinical services if seeking clinical care). Meet current (within last 30 days) DSM-5 criteria for cannabis use disorder. Submit a positive urine cannabinoid test during screening. Interested in treatment for cannabis use disorder. Exclusion Criteria: 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. The presence of any substance use disorder requiring a higher level of care. Significant risk of homicide or suicide. Pregnant, trying to become pregnant, or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Program Coordinator
Phone
843-792-0493
Email
bransonk@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel L Tomko, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aimee L McRae-Clark, PharmD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Program Coordinator
Phone
843-792-0493
Email
bransonk@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Gender/Sex & CUD Remission

We'll reach out to this number within 24 hrs