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

Not Applicable

Active, not recruiting

• Conditions: Opioid Dependence; Opioid-use Disorder

• Registration Number: NCT04664062
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-11
• Study Start: 2021-05-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-01-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 303

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of days patient took illicit opioids	270 days	Determined by a patient self-report of the number of days they took other opioids and urine opioid test results.
Took buprenorphine on >80% of days	270 days	Determined by initial prescription and refills, a patient self-report of number of days buprenorphine taken, and urine buprenorphine results.
Number of days patient took buprenorphine	270 days	Determined by prescription refills and patient self-report of number of days buprenorphine taken.
Percent (%) of patients that took other opioids on <10% of days	270 days	Determined by a patient self-report of the numer of days they took other opioids and urine opioid test results.

Secondary Outcome Measures

Name	Time	Method
Social Determinant of Health and Quality of Life	270 days	Patient surveys completed per clinical care on quality of life (e.g., symptoms, side effects, depression), social connectedness, loneliness, and other select determinants of health.

Trial Locations

Locations (2)

University of Colorado; 🇺🇸 Denver, Colorado, United States

American Academy of Family Physicians National Research Network; 🇺🇸 Leawood, Kansas, United States