CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 275 enrolled
Drug / intervention
Telemedicine Linkage Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04575324
NCT04575324N/ACompleted

Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation): Development and Testing of a Health Navigation Approach for Linking Syringe Service Program Clients to Medication Assisted Treatment

Chestnut Health Systems·interventional·Posted Oct 5, 2020·Updated Jul 9, 2024

In Brief

A clinical study evaluating Telemedicine Linkage Intervention for Opioid-use Disorder. Completed, enrolled 275 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 5, 2020
Enrollment StartAug 24, 2020
Primary CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.7 years ago

Interventions

Telemedicine Linkage Interventionbehavioral

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.