Medication Assisted Treatment for Opioid Addiction (HOMER Trial)

N/A

Waitlist Available

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 270 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three different ways of beginning treatment for opioid addiction to see which works best. The methods being compared are in-person at a doctor's office, at-home, and through telehealth. The goal is to help people with opioid addiction in primary care settings.

Who is the study for?

This trial is for individuals aged 16 or older with opioid dependence, either due to addiction as per DSM-V criteria or chronic pain with long-term high-dose opioid use. Participants must be willing to complete surveys over nine months and accept random assignment to one of three Medication Assisted Treatment (MAT) induction methods: home, office, or telehealth.

What is being tested?

The HOMER study is testing whether home-based, office-based, or telehealth-based inductions are most effective for starting MAT in patients with Opioid Use Disorder. It aims to identify which patient characteristics might favor a particular method in primary care settings.

What are the potential side effects?

While the trial focuses on the method of induction rather than medication side effects directly, buprenorphine/naloxone used in MAT can cause dizziness, drowsiness, constipation, headache and potential withdrawal symptoms if not properly managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 270 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~270 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 270 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of days patient took buprenorphine

Number of days patient took illicit opioids

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

+1 more

Secondary study objectives

Social Determinant of Health and Quality of Life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: HomeActive Control1 Intervention

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 II: OfficeActive Control1 Intervention

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 III: TelehealthActive Control1 Intervention

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.

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