Gender/Sex & CUD Remission

Study Overview
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Brief Summary
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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.

Official Title
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Gender and Sex Hormone Influences on Cannabis Use Disorder Remission

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

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT4CBT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |