## Protocol Section
### Identification Module
**NCT ID:** NCT05832879

**Brief Title:** Telehealth Treatment for Opioid Use Disorders

**Official Title:** A Pilot Study of Telehealth Treatment for Opioid Use Disorders

#### Organization Study ID Info
**ID:** 2000034414
#### Organization
**Class:** OTHER
**Full Name:** Yale University
#### Secondary ID Infos
**ID:** 1R61DA057675-01
**Link:** https://reporter.nih.gov/quickSearch/1R61DA057675-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-25

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-04-27
**Type:** ACTUAL
**Study First Submit Date:** 2023-04-14
**Study First Submit QC Date:** 2023-04-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Opioid Use Disorder

**Keywords:**

- Harm Reduction

- Medication for Opioid Use Disorder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff.

**Intervention Names:**

- Behavioral: OUD Telehealth Platform

**Label:** OUD Telehealth Platform

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- OUD Telehealth Platform

**Description:** The platform is intended to encourage engagement in treatment with medications for opioid use disorder (MOUD) through a chat dialogue with users

**Name:** OUD Telehealth Platform

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Overall attendance will be measured by attendance (yes or no) at the first buprenorphine appointment within 30 days of referral.

**Measure:** Attendance for MOUD

**Time Frame:** Up to 30 Days

#### Secondary Outcomes

**Description:** Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of referral.

**Measure:** Engagement with MOUD

**Time Frame:** Up to 90 days

**Description:** A self-report of the number of subsequent overdose events at 30 days.

**Measure:** Overdose Events at 30 Days

**Time Frame:** Up to 30 days

**Description:** A self-report of the number of subsequent overdose events at 90 days.

**Measure:** Overdose Events at 90 Days

**Time Frame:** Up to 90 days

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rebekah.heckmann@yale.edu

**Name:** Rebekah Heckmann, MD, MPH, MPA

**Phone:** (203) 737-8335

**Role:** CONTACT

**Contact 2:**

**Email:** michael.pantalon@yale.edu

**Name:** Michael Pantalon, PhD

**Phone:** (203) 785-4363

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Haven

**Country:** United States

**Facility:** Yale School of Medicine

**State:** Connecticut

**Status:** RECRUITING

**Zip:** 06520

#### Overall Officials

**Official 1:**

**Affiliation:** Yale School of Medicine

**Name:** Rebekah Heckmann, MD, MPH, MPA

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Data will be shared as part of the HEAL Initiative Consortium.

**IPD Sharing:** YES

**Time Frame:** Following the close of the study and final reporting to funder.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000079524

- Term: Narcotic-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: HIGH

- As Found: Opioid Use Disorder

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: HIGH

- As Found: Opioid Use Disorder

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009293

- Term: Opioid-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
