Gender/Sex & CUD Remission

Medical University of South Carolina (MUSC)

Status: Completed

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

Treatments: Behavioral: Cognitive Behavioral Therapy (CBT4CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04964739

00110801

R01DA054617 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

224 participants in 2 patient groups

Cognitive Behavioral Therapy - Men

Other group

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT4CBT)

Cognitive Behavioral Therapy - Women

Other group

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT4CBT)