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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06250153
Other study ID # Pro00133783
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date March 1, 2026

Study information

Verified date April 2024
Source Medical University of South Carolina
Contact Constance Guille, MD
Phone 8437926489
Email guille@musc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. a text message-based screening, phone-based brief intervention, and referral to treatment by a remote care coordinator (m-SBIRT; intervention arm), versus 2. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 442
Est. completion date March 1, 2026
Est. primary completion date March 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Immediately following screening.
Primary 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. Within one month of referral to treatment.
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