Gender and Sex Hormone Influences on Cannabis Use Disorder Remission
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- Proportion of participants in remission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Cognitive Behavioral Therapy (CBT4CBT) (Behavioral)
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.
Intervention: Cognitive Behavioral Therapy (CBT4CBT) (Behavioral)
Outcomes
Primary Outcomes
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.
Reduction in cannabis use days
Time Frame: 8 weeks of treatment
Number of cannabis use days assessed via daily diaries during treatment
Reduction in cannabis use episodes
Time Frame: 8 weeks of treatment
Number of cannabis use episodes assessed via daily diaries during treatment
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.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported