Substance Use DisordersNCT06250153
TAU vs m-SBIRT in Primary Care
A study testing m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment) in people with Substance Use Disorders, run by Medical University of South Carolina.
Trial summary
The goal of this research is to leverage technology in primary care clinics to improve screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and treatment attendance by comparing 1. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Oct 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75
- Attended a primary care visit at the MUSC Family Medicine clinic on Bee St
- English fluency
- Owner of a cell phone with SMS text-message based capability
- Access to WIFI
- A device to allow audio and video teleconferencing if completing informed consent remotely
- Able to provide informed consent.
Who cannot join
- None
About this study
Official title: In-Person Versus Text/Telephone Screening, Brief Intervention and Referral to Treatment in Primary Care
The goal of this research is to leverage technology in primary care clinics to improve screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and treatment attendance by comparing
- a text message-based screening, phone-based brief intervention, and referral to treatment by a remote care coordinator (m-SBIRT; intervention arm), versus
- evidence-based, in-person Screening, Brief Intervention, and Referral to Treatment (SBIRT; Treatment As Usual (TAU); control arm).
Primary Aim is to compare the efficacy of m-SBIRT to TAU in positive screens for substance use. Secondary Aim is to compare m-SBIRT to TAU on Substance Use Treatment Attendance.
Read the detailed description
This research study is looking at the use of technology in primary care clinics and seeing if it improves screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and attendance to treatment. To do so the study, Investigators will be comparing a text message based substance use screening and treatment program, called Mobile Screening, Brief intervention, and Referral to Treatment (m-SBIRT) to standard of care Screening, Brief Intervention and Referral Treatment which traditionally takes place in-person. Patients at the MUSC Bee Street Primary Care Clinic between the ages of 18-75 may be eligible.
- Conditions
- Substance Use Disorders
- Being tested
- m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)
- Keywords
- Substance Use Disorders, Social Determinants of Health, Screening, Brief Intervention, Referral to Treatment (SBIRT), Telehealth, Mobile SBIRT (m-SBIRT), Primary Care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)Behavioural
M-SBIRT is a mobile phone-based program designed to enhance delivery of Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based approach for mental health and substance use screening and treatment. The program utilizes mobile phone text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to substance use disorder treatment services.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | This group will receive routine substance use screening questions during their in-person primary care visit as part of standard of care. |
| m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment) | Experimental | This group will receive a mobile phone text message based substance use screening (questions used in standard of care) with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to substance use disorder (SUD) treatment. Receives: Behavioral: m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive screens for substance use
A positive screen is defined as positive endorsement of substance use (alcohol, drugs, tobacco, etc) within the questionnaire. We will compare rates of positive screens for substance use in individuals assigned to m-SBIRT compared to TAU.
Measured: Immediately following screening.
Change in treatment attendance
Treatment attendance is defined as attending one or more visits to address substance use concerns within one month of referral. We will compare rates of treatment attendance of individuals assigned to m-SBIRT compared to TAU.
Measured: Within one month of referral to treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jan 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Constance Guille, MD, Principal investigator, Professor-Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250153
- Sponsor's protocol ID
- Pro00133783
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Person Versus Text/Telephone Screening, Brief Intervention and Referral to Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT06250153
- Acronym / sponsor ID
- Pro00133783
- Conditions
- Substance Use Disorders
- Keywords
- Substance Use Disorders, Social Determinants of Health, Screening, Brief Intervention, Referral to Treatment (SBIRT), Telehealth, Mobile SBIRT (m-SBIRT), Primary Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 8 Feb 2024 (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 goal of this research is to leverage technology in primary care clinics to improve screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and treatment attendance by comparing
- a text message-based screening, phone-based brief intervention, and referral to treatment by a remote care coordinator (m-SBIRT; intervention arm), versus
- evidence-based, in-person Screening, Brief Intervention, and Referral to Treatment (SBIRT; Treatment As Usual (TAU); control arm).
Primary Aim is to compare the efficacy of m-SBIRT to TAU in positive screens for substance use. Secondary Aim is to compare m-SBIRT to TAU on Substance Use Treatment Attendance.
Detailed description
This research study is looking at the use of technology in primary care clinics and seeing if it improves screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and attendance to treatment. To do so the study, Investigators will be comparing a text message based substance use screening and treatment program, called Mobile Screening, Brief intervention, and Referral to Treatment (m-SBIRT) to standard of care Screening, Brief Intervention and Referral Treatment which traditionally takes place in-person. Patients at the MUSC Bee Street Primary Care Clinic between the ages of 18-75 may be eligible.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –This group will receive routine substance use screening questions during their in-person primary care visit as part of standard of care. |
| m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment) | Experimental | Behavioral: m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)This group will receive a mobile phone text message based substance use screening (questions used in standard of care) with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to substance use disorder (SUD) treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75
- Attended a primary care visit at the MUSC Family Medicine clinic on Bee St
- English fluency
- Owner of a cell phone with SMS text-message based capability
- Access to WIFI
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)M-SBIRT is a mobile phone-based program designed to enhance delivery of Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based approach for mental health and substance use screening and treatment. The program utilizes mobile phone text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to substance use disorder treatment services. | Behavioural | m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment) |
Primary outcome
Positive screens for substance use
Time frame: Immediately following screening.
A positive screen is defined as positive endorsement of substance use (alcohol, drugs, tobacco, etc) within the questionnaire. We will compare rates of positive screens for substance use in individuals assigned to m-SBIRT compared to TAU.
Change in treatment attendance
Time frame: Within one month of referral to treatment.
Treatment attendance is defined as attending one or more visits to address substance use concerns within one month of referral. We will compare rates of treatment attendance of individuals assigned to m-SBIRT compared to TAU.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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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.
Constance Guille, MD principal investigator
Professor-Faculty
Questions about this trial
What is this clinical trial studying?
A study testing m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment) in people with Substance Use Disorders, run by Medical University of South Carolina.
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 1 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: withdrawn, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Positive screens for substance use (time frame: Immediately following screening.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2025.