Cannabis UseNCT05566730
Culturally Tailored Cannabis Use Disorder App
A study testing CT-MICART App in people with Cannabis Use, run by University of Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Use
- What is being tested?
- CT-MICART App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cannabis Use
- Being tested
- CT-MICART App, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-MICART AppBehavioural
App designed with the goal of treating CUD in African American adults
ControlBehavioural
Also called Sham
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
| Study group | Role | What they receive |
|---|---|---|
| CT-MICART App | Experimental | Participants in this arm will receive daily EMAs for 6 weeks. Receives: Behavioral: CT-MICART App; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Week 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start14 Jun 2023
- Primary completion17 Nov 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Louisiana State University Health Sciences Center in New Orleans, University of Oklahoma
- Responsible party
- Principal investigator, Lorra Garey, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566730
- Sponsor's protocol ID
- STUDY00003690
- Other IDs
- U54MD015946
- Status last verified
- May 2024
- First submitted
- 24 Jun 2022
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38373037
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile App to Address CUD Among Black Adults
- ClinicalTrials.gov ID
- NCT05566730
- Acronym / sponsor ID
- STUDY00003690
- Conditions
- Cannabis Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Louisiana State University Health Sciences Center in New Orleans, University of Oklahoma
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-MICART App | Experimental | Behavioral: CT-MICART App, Behavioral: ControlParticipants in this arm will receive daily EMAs for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-MICART AppApp designed with the goal of treating CUD in African American adults | Behavioural | CT-MICART App |
| ControlAlso: ShamApp designed with the goal of treating CUD in African American adults, with participants just tracking their use of cannabis and not receiving treatment videos | Behavioural | CT-MICART App |
Primary outcome
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 38373037Nizio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-MICART App in people with Cannabis Use, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Aid Scale (time frame: Baseline appointment and 6-week follow up appointment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.