Culturally Tailored Cannabis Use Disorder App
Primary Purpose
Cannabis Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT-MICART App
Control
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use
Eligibility Criteria
Inclusion Criteria:
- at least 18 years of age
- identify as Black/African American
- CUD per DSM-5 (current/past month use confirmed via urine)
- willing and able to attend a baseline visit
- 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)
Sites / Locations
- University of HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT-MICART App
Arm Description
Participants in this arm will receive daily EMAs for 6 weeks.
Outcomes
Primary Outcome Measures
Safety Aid Scale
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.
Qualitative Interview
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.
Engagement with the CT-MICART app
Behavioral indicators of engagement with the app (>75% of all videos watched and >75% of scheduled skills practiced).
Secondary Outcome Measures
Full Information
NCT ID
NCT05566730
First Posted
June 24, 2022
Last Updated
June 26, 2023
Sponsor
University of Houston
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Louisiana State University Health Sciences Center in New Orleans, University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT05566730
Brief Title
Culturally Tailored Cannabis Use Disorder App
Official Title
Mobile App to Address CUD Among Black Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
October 23, 2023 (Anticipated)
Study Completion Date
December 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Louisiana State University Health Sciences Center in New Orleans, University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-MICART App
Arm Type
Experimental
Arm Description
Participants in this arm will receive daily EMAs for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
CT-MICART App
Intervention Description
App designed with the goal of treating CUD in African American adults
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
Sham
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety Aid Scale
Description
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.
Time Frame
Baseline appointment and 6-week follow up appointment
Title
Qualitative Interview
Description
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.
Time Frame
6-week follow up appointment
Title
Engagement with the CT-MICART app
Description
Behavioral indicators of engagement with the app (>75% of all videos watched and >75% of scheduled skills practiced).
Time Frame
Week 1-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorra Garey, PhD
Phone
713-743-8056
Email
llgarey@uh.edu
12. IPD Sharing Statement
Learn more about this trial
Culturally Tailored Cannabis Use Disorder App
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