Clinical trial NCT05832879: Telehealth Treatment for Opioid Use Disorders
Official title: A Pilot Study of Telehealth Treatment for Opioid Use Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Harm Reduction
Medication for Opioid Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate its preliminary efficacy in terms of motivating engagement in medications for OUD (MOUD), as well as its feasibility, acceptability and satisfaction to both first responders/providers and participants.

Detailed description: The primary objective of the study is to assess effects of enrollment in a comprehensive telehealth platform, in adults with moderate or severe opioid use disorder with a history of at least one opioid overdose. Thirty adults with moderate or severe opioid use disorder with a history of at least one opioid overdose will be enrolled and the primary endpoint will be attendance at first appointment for medication for opioid use disorder at 30 days.

Secondary aims include assessing engagement in the first MOUD appointment at 90 days and self-report of the number of subsequent overdose events at 30 and 90 days. Exploratory aims include feasibility of intervention, readiness and intention to engage in treatment, acceptability and satisfaction of intervention, and comparison of MOUD engagement with data from previous in-person studies.

Eligibility criteria: Inclusion Criteria:

* Can speak, read and write in English
* Provision of signed and dated informed consent form
* Have a history of at least one opioid overdose
* Screened positive for OUD, moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition
* Have a working cell phone number and working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer) OR be willing to use a device provided by the study team
* Can provide a working email address OR be willing to create one

Exclusion Criteria:

* Current use of buprenorphine, methadone, or naltrexone for a substance use disorder
* Pregnancy or lactation
* Known current suicide risk based on participant self-report
* On parole or incarcerated at time of enrollment based on participant self-report

Primary outcomes:
measure: Attendance for MOUD
timeFrame: Up to 30 Days
Secondary outcomes:
measure: Engagement with MOUD
timeFrame: Up to 90 days
measure: Overdose Events at 30 Days
timeFrame: Up to 30 days
measure: Overdose Events at 90 Days
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Rebekah Heckmann, MD, MPH, MPA
role: PRINCIPAL_INVESTIGATOR
References: