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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cognitive Behavioral Therapy - Males
112 male participants were enrolled in 8 weeks of behavioral treatment for cannabis use disorder (CUD). They received a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. |
Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT. |
|
Other: Cognitive Behavioral Therapy - Females
112 female participants were enrolled in 8 weeks of behavioral treatment for cannabis use disorder (CUD). They received a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. |
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
Time Frame: Week 4
|
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
Time Frame: Week 8
|
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
Time Frame: Week 12
|
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
Time Frame: Week 16
|
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
Time Frame: Week 20
|
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
Time Frame: 8 weeks of treatment
|
Number of cannabis use days assessed via daily diaries during treatment, past 28 days |
8 weeks of treatment
|
|
Reduction in Cannabis Use Episodes
Time Frame: 8 weeks of treatment
|
Number of cannabis use grams assessed via daily diaries during treatment, last 28 days |
8 weeks of treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rachel L Tomko, PhD, Medical University of South Carolina
- Principal Investigator: Aimee L McRae-Clark, PharmD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Hemic and Lymphatic Diseases
- Lymphoma, Follicular
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Cognitive Behavioral Therapy
Other Study ID Numbers
- 00110801
- R01DA054617 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
IPD Sharing Time Frame
Requests for data from this project by individuals outside of the research team will be reviewed by the team 180 days after study completion.
IPD Sharing Access Criteria
The requesting Investigator must specify the subset of variables needed. 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. Data will be shared via CSV file or other requested formats, if the study team is able to accommodate the alternative requested format.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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