NCT04964739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2025

Completed
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

July 11, 2021

Last Update Submit

November 6, 2025

Conditions

Cannabis Use Disorder, MildCannabis Use Disorder, ModerateCannabis Use Disorder, Severe

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Reduction in cannabis use days

    Number of cannabis use days assessed via daily diaries during treatment

    8 weeks of treatment

  • Reduction in cannabis use episodes

    Number of cannabis use episodes assessed via daily diaries during treatment

    8 weeks of treatment

Study Arms (2)

Cognitive Behavioral Therapy - Men

OTHER

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.

Behavioral: Cognitive Behavioral Therapy (CBT4CBT)

Cognitive Behavioral Therapy - Women

OTHER

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.

Behavioral: Cognitive Behavioral Therapy (CBT4CBT)

Interventions

Cognitive Behavioral Therapy (CBT4CBT)BEHAVIORAL

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

Cognitive Behavioral Therapy - MenCognitive Behavioral Therapy - Women

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rachel L Tomko, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Aimee L McRae-Clark, PharmD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2021

First Posted

July 16, 2021

Study Start

November 15, 2021

Primary Completion

October 27, 2025

Study Completion

October 27, 2025

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Investigators support data sharing as essential for scientific advancement. It is expected that primary outcome papers will be completed and submitted to appropriate peer-reviewed scientific journals within 180 days of data lock. Requests for data from this project by individuals outside of the research team will be reviewed by the team following data lock. Data sharing will adhere to all provisions of the Health Insurance Portability and Accountability Act (HIPAA) and the rights and privacy of people who participate in research will be protected at all times. The requesting Investigator must specify the subset of variables needed or provide a detailed justification of why the complete dataset is absolutely necessary. Data made available to other investigators will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.

Locations

US(1)