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

NCT ID: NCT04664062

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2026-02-28

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.

Detailed Description

Office-based Opioid Treatment (OBOT) is the primary care or ambulatory care provision of medication assisted treatment (MAT) for patients suffering opioid use disorder (OUD). MAT with buprenorphine in primary care clinics is a proven strategy to treat opioid use disorder (OUD) and is slowly becoming accessible to patients through primary care. Treating patients with buprenorphine involves an initial induction, during which patients discontinue their opioids, begin withdrawal, and receive the first few doses of buprenorphine. National guidelines for OBOT have focused on observed, office-based induction to begin MAT. Over the years, unobserved, home MAT inductions have also been used and shown to be safe and effective. Individually, each induction strategy is evidence-based, guideline concordant care. In light of the current COVID-19 pandemic, inductions are also being conducted via telehealth using synchronous audio or video observation. Most research, on which the current guidelines are based, examined short-term outcomes. However, OUD is a chronic condition. MAT often involves intermittent return to illicit opioid use and treatment lapses, resulting in multiple attempts to remain in long-term treatment. Important differences between the activities that occur during home, office-based, and telehealth induction might influence short-term stabilization, long-term maintenance treatment, and quality of life outcomes. No large-scale, multi-center, randomized comparative effectiveness research has compared induction method on long-term outcomes for patients suffering from OUD seen in primary care settings.There is currently insufficient evidence to recommend home induction (asynchronous, unobserved), office induction (synchronous, observed), or telehealth induction (synchronous phone or video contact, observed).

Acknowledging the dire need for increased access to effective treatment for OUD, patients and providers are eager to better understand if home, office-based, or telehealth induction in the primary care setting leads to more successful short-term stabilization and long-term maintenance treatment and patient outcomes. They also question whether certain patient characteristics, such as substance use history, executive function, and social determinants of health, are associated with better long-term outcomes in patients receiving one method versus the others. We propose a comparative effectiveness research study, randomized at the patient level, to compare short-term stabilization and long-term maintenance treatment outcomes of home induction (asynchronous, unobserved), office induction (synchronous, observed), or telehealth induction (synchronous phone or video contact, observed) for patients suffering from OUD and opioid dependence.

Conditions

Opioid-use Disorder; Opioid Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home

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.

Group Type: ACTIVE_COMPARATOR

Medication Assisted Treatment

Intervention Type: 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.

Office

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).

Group Type: ACTIVE_COMPARATOR

Medication Assisted Treatment

Intervention Type: 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.

Telehealth

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.

Group Type: ACTIVE_COMPARATOR

Medication Assisted Treatment

Intervention Type: 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.

Interventions

Medication Assisted Treatment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Academy of Family Physicians National Research Network

NETWORK

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado

Denver, Colorado, United States

American Academy of Family Physicians National Research Network

Leawood, Kansas, United States

Countries

United States

Other Identifiers

20-1692

Identifier Type: -

Identifier Source: org_study_id