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Behavioral Intervention

Home for Opioid Use Disorder (HOMER Trial)

N/A
Recruiting
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

HOMER Trial 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.

Eligible Conditions
  • Opioid Use Disorder
  • Opioid Addiction

HOMER Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Social Determinant of Health and Quality of Life

HOMER 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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,731 Previous Clinical Trials
2,143,199 Total Patients Enrolled
American Academy of Family Physicians National Research NetworkNETWORK
7 Previous Clinical Trials
63,686 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for any new participants to join this investigation?

"Affirmative. Clinicaltrials.gov records that this research study, initially posted on May 13th 2021, is actively seeking participants. 1400 patients are needed between two distinct medical facilities."

Answered by AI

Who is eligible to participate in this experiment?

"This trial is searching for 1400 individuals between the ages of sixteen and eighty-nine who have a history of substance abuse. Beyond this, the potential participants must also meet select criteria such as being diagnosed with opioid dependence according to DSM-V standards or having chronic pain that necessitates long term, high dose opioid use (for at least one year). Furthermore, these volunteers need to agree to fill out survey questions four times over nine months during their enrollment in treatment."

Answered by AI

Does this research encompass participants over the age of 40?

"This trial is recruiting patients aged 16 to 89. Furthermore, there are 90 clinical trials for minors and 402 for elderly individuals above the age of 65."

Answered by AI

How many individuals are taking part in this medical trial?

"Affirmative. According to clinicaltrials.gov, this study is still recruiting participants and was first made available on May 13th 2021 with the most recent update having taken place on August 11th 2022. A total of 1400 individuals are being sought across two sites."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
What site did they apply to?
American Academy of Family Physicians National Research Network
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparing Home, Office, and Telehealth Induction for Medication Assisted Treatment for Opioid Use Disorder
2021. "Comparing Home, Office, and Telehealth Induction for Medication Assisted Treatment for Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04664062.
~357 spots leftby Apr 2025
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