- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566730
Culturally Tailored Cannabis Use Disorder App
May 6, 2024 updated by: Lorra Garey, University of Houston
Mobile App to Address CUD Among Black Adults
The present study aims to address disparities in cannabis use outcomes among African American/Black (hereby referred to as Black) adults with cannabis use disorder (CUD).
The specific aims of this study are: (1) to develop a culturally adapted, mobile app for Black cannabis users (CT-MICART) using knowledge from the current research team, published literature, expert opinion, and feedback from the Community Research Advisory Board (CRAB), (2) to pilot test CT-MICART and (3) focus on analysis of data collected as part of Aim 2.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present study aims to address disparities in cannabis use outcomes among African American/Black (hereby referred to as Black) adults with cannabis use disorder (CUD).
African American/Black adults are more likely to endorse cannabis use patterns that are more severe (weekly and blunt use) and meet diagnostic criteria for cannabis use disorder (CUD) than White adults (16.8% vs 10.0%).
This finding is alarming as cannabis use disorder is associated with more severe psychosocial risk profiles, including poly-substance use, psychiatric problems, and legal trouble relative to non-CUD use and non-use.
Additionally, although Black cannabis users are more likely to report being ready to quit and a recent quit attempt relative to White cannabis users, this population is less likely to seek in-person treatment relative to White cannabis users because of individual (e.g., beliefs about use), community (e.g., neighborhood attitudes about use), and institutional (e.g., healthcare access) factors as well as due to institutionalized racism and discrimination (e.g., more likely to not be listened to by practitioners).
Targeted, accessible, and culturally adapted therapeutic programming is needed to reduce risk and improve disparities for poor cannabis-related outcomes among Black adults with cannabis use disorder.
These findings are significant because they contribute to heath, social, and psychological health disparities within the Black community.
Psycho-sociocultural models of substance use posit that Black individuals may use cannabis and continue using despite cannabis-related problems including cannabis use disorder, to manage psychological distress associated with stressors associated with minority status, such as racial discrimination.
Therefore, the present study seeks to develop a culturally adapted, mobile app tailored specifically for Black cannabis users (CT-MICART).
Using the expert opinion and feedback from the community Research Advisory Board (CRAB), the investigative team will pilot test CT-MICART and focus on analysis of data collected to help achieve a better culturally tailored app.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Houston, Texas, United States, 77004
- University of Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- at least 18 years of age
- identify as Black/African American
- CUD per CUPIT-R
- willing and able to complete study appointments
- motivated to reduce cannabis (≥5 on a 10-point scale)
- score ≥ 4 on the REALM-SF indicating ≥ 6th grade English literacy level (needed to use app)
- report cannabis use to manage anxiety/stress in the past month
Exclusion Criteria:
- legal mandate or substance misuse treatment
- report of current or intended participation in a concurrent substance use treatment, including pharmacotherapy or psychotherapy for CUD not provided by researchers
- ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression
- not being fluent in English
- pregnant of planning to become pregnant within the next six months (assessed via self-report)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CT-MICART App
Participants in this arm will receive daily EMAs for 6 weeks.
|
App designed with the goal of treating CUD in African American adults
App designed with the goal of treating CUD in African American adults, with participants just tracking their use of cannabis and not receiving treatment videos
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Aid Scale
Time Frame: Baseline appointment and 6-week follow up appointment
|
The Safety Aid Scale will be used to assess change of false safety behavior use over time, being scored on a 5 point scale where higher scores indicate greater use of false safety behaviors.
|
Baseline appointment and 6-week follow up appointment
|
|
Qualitative Interview
Time Frame: 6-week follow up appointment
|
The qualitative interview done by the participants will ask them about their experience with the app, what aspects helped, what aspects didn't help, and will allow researchers to adapt and refine the CT-MICART app.
|
6-week follow up appointment
|
|
Engagement with the CT-MICART app
Time Frame: Week 1-6
|
Behavioral indicators of engagement with the app (>75% of all videos watched and >75% of scheduled skills practiced).
|
Week 1-6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2023
Primary Completion (Actual)
November 17, 2023
Study Completion (Actual)
January 31, 2024
Study Registration Dates
First Submitted
June 24, 2022
First Submitted That Met QC Criteria
September 29, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003690
- U54MD015946 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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