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Gender/Sex & CUD Remission

Gender and Sex Hormone Influences on Cannabis Use Disorder Remission

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04964739
Enrollment
224
Registered
2021-07-16
Start date
2021-11-15
Completion date
2025-10-27
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy (CBT4CBT)

Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of participants in remissionWeek 4Remission 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 days8 weeks of treatmentNumber of cannabis use days assessed via daily diaries during treatment
Reduction in cannabis use episodes8 weeks of treatmentNumber of cannabis use episodes assessed via daily diaries during treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026