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OpenTrials
Completed

NCT Number: NCT04964739

Gender/Sex & CUD Remission

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.

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Key information

Conditions

Cannabis Use Disorder, Mild Cannabis Use Disorder, Moderate Cannabis Use Disorder, Severe Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy (CBT4CBT)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Reduction in cannabis use days

    Time frame: 8 weeks of treatment

    Number of cannabis use days assessed via daily diaries during treatment

  7. Reduction in cannabis use episodes

    Time frame: 8 weeks of treatment

    Number of cannabis use episodes assessed via daily diaries during treatment

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Gender and Sex Hormone Influences on Cannabis Use Disorder Remission

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2021
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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