Comparing Home, Office, and Telehealth Induction for Medication Assisted Treatment for Opioid Use Disorder

NCT04664062 | Active Not Recruiting DMC

• 1 other identifier: 20-1692
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 2

Brief Summary

HOMER is a national study comparing three methods of induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); home versus office versus telehealth-based inductions. This study will help determine if certain patient and practice characteristics make patients better candidates for one method over the others. Results will help fill a gap in the evidence around effectively treating OUD with MAT in primary care settings.

Conditions

Opioid-use Disorder; Opioid Dependence

Outcome Measures

Primary Outcomes (4)

• Number of days patient took buprenorphine

  Determined by prescription refills and patient self-report of number of days buprenorphine taken.

  270 days

• Number of days patient took illicit opioids

  Determined by a patient self-report of the number of days they took other opioids and urine opioid test results.

  270 days

• Took buprenorphine on >80% of days

  Determined by initial prescription and refills, a patient self-report of number of days buprenorphine taken, and urine buprenorphine results.

  270 days

• Percent (%) of patients that took other opioids on <10% of days

  Determined by a patient self-report of the numer of days they took other opioids and urine opioid test results.

  270 days

Secondary Outcomes (1)

• Social Determinant of Health and Quality of Life

  270 days

Study Arms (3)

Home

ACTIVE COMPARATOR

This induction arm is asynchronous and unobserved. The home induction is done primarily by the participant in their home or current residence. The participant receives instruction on induction process from clinic team at an in-person or telehealth visit. Home induction is initiated by the participant at a time and place (other than the practice) determined by the participant. The participant determines when to stop taking opioids, begins withdrawal, monitors symptoms, administers the SOWS, and determines when to take first dose of medication, per the instructions and protocol provided. The clinic team does not observe or have contact with the participant while the participant undergoes these steps or takes the first dose. The participant continues this process for additional doses. Follow-up contact with clinic team may occur after the first or second day, typically within a week.

Behavioral: Medication Assisted Treatment

Office

ACTIVE COMPARATOR

This induction arm is synchronous and observed by the clinical team. The participant receives instruction from clinic team at an in-person or telehealth visit. On a pre-determined day, the participant stops taking opioids and comes to office with mild to moderate withdrawal. The clinic team monitors the participant, assesses symptoms, administers COWS to determine time of first dose of medication, and administers first dose with the participant. The clinic team observes and has in-person contact with the participant. Office induction includes the observed administration of the first dose, followed by observation and evaluation 30-60 minutes after the first dose. After 30-60 minutes of observation, the clinic team and participant decide whether to administer the second dose in the office or for the participant to leave the clinic to administer subsequent doses. On rare occasions, a second dose may not be needed (if the participant has a low COWS score after just one dose).

Behavioral: Medication Assisted Treatment

Telehealth

ACTIVE COMPARATOR

This induction arm is synchronous via phone or video contact and observed. The participant receives instruction on induction process from clinic team at an in-person or telehealth visit. The participant undergoes the same process as an office induction but from a location other than the clinic. Like an office induction, the participant has regular contact with someone from the practice team on Day 1 of induction. Prior to initiating the first dose, the participant has contact by phone or video with the clinic team to assess symptoms and determine level of withdrawal (using COWS or SOWS). The administration of the first dose of medication is determine by the clinic team during phone or video contact, and the clinic team is in contact with the participant by phone or video when the first dose is taken. This process continues through the second and possible third dose. The participant is re-assessed via video or phone regularly by clinic staff and prescriber throughout this process.

Behavioral: Medication Assisted Treatment

Interventions

Medication Assisted Treatment BEHAVIORAL

All subjects will undergo MAT induction with buprenorphine. Participants will be randomized to the behavioral aspects of induction, specifically comparing office induction vs home vs synchronous telehealth induction.

Home; Office; Telehealth

Eligibility Criteria

• Age: 16 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 16 and older Identified by their clinician as having opioid dependence and either 1) addiction as defined by DSM-V criteria for OUD and/or 2) chronic pain with long-term, high dose opioid use (greater than one year and morphine equivalent daily dose higher than recommended by the CDC).
• Seeking or agreeing to receive medication assisted treatment (MAT) with buprenorphine or Suboxone (buprenorphine/naloxone).
• Agree to be randomly assigned to undergo MAT induction with one of the three methods being compared in this study.
• home induction (asynchronous, unobserved)
• office induction (synchronous, observed)
• telehealth induction (synchronous phone or video contact, observed) Agree to answer a set of survey questions four times over a nine month period (at the time of enrollment plus 1, 3, and 9 months after starting treatment.

You may not qualify if:

• Hypersensitivity to buprenorphine or naloxone. Are known to have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than five times normal.
• Are diagnosed with severe, untreated psychiatric illness. Have a preference for one of the MAT induction methods and do not want to be randomly assigned to one.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Academy of Family Physicians National Research Network: collaborator

Study Sites (2)

University of Colorado

Denver, Colorado, 80045, United States

Location

American Academy of Family Physicians National Research Network

Leawood, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Opiate Substitution Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: May 13, 2021
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)