Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation)

NCT04575324 | Completed Results DMC

• 1 other identifier: 1138-0420
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

Project STAMINA is a clinical trial that seeks to establish effectiveness of a telemedicine approach for linking syringe exchange clients to medications for opioid use disorder. This pilot study aims to recruit n=275 people and utilizes two study arms: (1) a treatment arm consisting of immediate telemedicine linkage and (2) a control arm consisting of standard referral to treatment. Half of the study participants will be randomly enrolled in each arm. The study will utilize qualitative and quantitative data, including questionnaire data, drug test results, and administrative treatment data, at multiple time points to determine what effect telemedicine linkage has on clients in relation to the comparison group.

Conditions

Opioid-use Disorder

Keywords

Opioid Use Disorder; Injection Drug Use; Telemedicine; Telehealth; Syringe Exchange; Medication for Opioid Use Disorder; Medication Assisted Treatment; Substance Use Disorder; Syringe Service Program; Needle Exchange

Outcome Measures

Primary Outcomes (1)

• Linkage to Medication for Opioid Use Disorder (MOUD)

  Whether the participant attends 1 in-person MOUD treatment appointment

  Within 14 days of enrollment

Secondary Outcomes (4)

• Medication for Opioid Use Disorder (MOUD) Treatment Engagement

  Within 34 days of enrollment

• Medication for Opioid Use Disorder (MOUD) Treatment Retention

  3 month study period

• Self-report Non-medication for Opioid Use Disorder (MOUD) Opioid Use

  3 month study period

• Detected Non-prescribed Opioids

  3 month study period

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants will receive the telemedicine linkage intervention.

Behavioral: Telemedicine Linkage Intervention

Control Arm

NO INTERVENTION

Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.

Interventions

Telemedicine Linkage Intervention BEHAVIORAL

Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• communicate in English
• be at least 18 years of age
• reside in Cook County, Illinois
• score at least "2" on the Opioid Use Disorder Screening tool (DSM), indicating mild opioid use disorder
• express interest in receiving medication for an opioid use disorder (MOUD)

You may not qualify if:

• have plans to move outside of Cook County, Illinois within the next 6 months
• have plans to serve a sentence that requires reporting to jail or prison within the next 6 months
• score "36" or higher on the Clinical Opioid Withdrawal Scale (COWS), indicating severe opioid withdrawal symptoms
• currently taking any form of medication that has been prescribed by a healthcare provider to treat opioid use disorder
• demonstrate inadequate ability to provide informed consent, as indicated by poor understanding of research based on 3 competency questions asked related to study.

Sponsors & Collaborators

• Chestnut Health Systems: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

University of Illinois at Chicago Community Outreach Intervention Projects (COIP) Field Site

Chicago, Illinois, 60647, United States

Location

Related Publications (3)

• Franceschini D, Swartz JA, Watson DP, Mackesy-Amiti ME, Taylor L, Zhao P, Messmer S, Jimenez AD, Gastala N. Syringe Service Program-Based Telemedicine Linkage to Opioid Use Disorder Treatment: Results From a Pragmatic Randomized Trial of the STAMINA Intervention. Subst Use. 2025 Nov 24;19:29768357251372336. doi: 10.1177/29768357251372336. eCollection 2025 Jan-Dec.

  PMID: 41306931 DERIVED

• Watson DP, Ray B, Phalen P, Duhart Clarke SE, Taylor L, Swartz J, Gastala N. Fentanyl Exposure and Detection Strategies Utilized by Clinical Trial Participants Seeking Linkage to Opioid Use Disorder Treatment at a Syringe Service Program. J Med Toxicol. 2024 Jan;20(1):13-21. doi: 10.1007/s13181-023-00979-7. Epub 2023 Dec 4.

  PMID: 38048033 DERIVED

• Watson DP, Swartz JA, Robison-Taylor L, Mackesy-Amiti ME, Erwin K, Gastala N, Jimenez AD, Staton MD, Messmer S. Syringe service program-based telemedicine linkage to opioid use disorder treatment: protocol for the STAMINA randomized control trial. BMC Public Health. 2021 Mar 31;21(1):630. doi: 10.1186/s12889-021-10669-0.

  PMID: 33789642 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

The internal validity of the results of the study are restricted by the study's use of a pragmatic approach and limited control over the intervention and clients' MOUD treatment. Though our goal was to ensure generalizability and sustainability of the intervention, providing participants with autonomy over their methadone provider resulted in missing administrative data as data use agreements were only established with our FQHC partner and the city's largest methadone provider.

Results Point of Contact

• Title: Dr. Dennis Watson
• Organization: Chestnut Health Systems

dpwatson@chestnut.org

312-274-5316

Study Officials

• Dennis P Watson, PhD

  Chestnut Health Systems

  PRINCIPAL INVESTIGATOR

• James A Swartz, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: August 24, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-07

Locations

US (1)