N/A
N=275
Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation)
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04575324 ↗Enrolled (actual)
275
Serious AEs
25.8%
Results posted
Jul 2024
Primary outcome: Primary: Linkage to Medication for Opioid Use Disorder (MOUD) — 25; 47; 113; 89 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telemedicine Linkage Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chestnut Health Systems
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linkage to Medication for Opioid Use Disorder (MOUD) |
25; 47; 113; 89 | — |
| SECONDARY Medication for Opioid Use Disorder (MOUD) Treatment Engagement |
19; 29; 119; 107 | — |
| SECONDARY Medication for Opioid Use Disorder (MOUD) Treatment Retention |
12; 14; 126; 122 | — |
| SECONDARY Self-report Non-medication for Opioid Use Disorder (MOUD) Opioid Use |
19.09; 19.92 | — |
| SECONDARY Detected Non-prescribed Opioids |
52; 56; 21; 20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04575324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.