Gender/Sex & CUD Remission

Cannabis Use Disorder, Moderate Clinical Trial

Official title:

Gender and Sex Hormone Influences on Cannabis Use Disorder Remission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04964739
• Other study ID #: 00110801
• Secondary ID: R01DA054617
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: Kevin Branson
• Phone: 843-792-0493
• Email: bransonk[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use Disorder, Mild
• Cannabis Use Disorder, Moderate
• Cannabis Use Disorder, Severe
• Marijuana Abuse

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT4CBT)
Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Reduction in cannabis use days	Number of cannabis use days assessed via daily diaries during treatment	8 weeks of treatment
Primary	Reduction in cannabis use episodes	Number of cannabis use episodes assessed via daily diaries during treatment	8 weeks of treatment