NCT05566730

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 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

June 24, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

June 24, 2022

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline appointment and 6-week follow up appointment

  • 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.

    6-week follow up appointment

  • Engagement with the CT-MICART app

    Behavioral indicators of engagement with the app (\>75% of all videos watched and \>75% of scheduled skills practiced).

    Week 1-6

Study Arms (1)

CT-MICART App

EXPERIMENTAL

Participants in this arm will receive daily EMAs for 6 weeks.

Behavioral: CT-MICART AppBehavioral: Control

Interventions

CT-MICART AppBEHAVIORAL

App designed with the goal of treating CUD in African American adults

CT-MICART App
ControlBEHAVIORAL

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

Also known as: Sham
CT-MICART App

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77004, United States

Location

Related Publications (1)

  • Nizio P, Clausen B, Businelle MS, Ponton N, Jones AA, Redmond BY, Buckner JD, Obasi EM, Zvolensky MJ, Garey L. Mobile Intervention to Address Cannabis Use Disorder Among Black Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 19;13:e52776. doi: 10.2196/52776.

MeSH Terms

Interventions

salicylhydroxamic acid

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2022

First Posted

October 4, 2022

Study Start

June 14, 2023

Primary Completion

November 17, 2023

Study Completion

January 31, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations