Status:
ACTIVE_NOT_RECRUITING
Comparing Home, Office, and Telehealth Induction for Medication Assisted Treatment for Opioid Use Disorder
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
American Academy of Family Physicians National Research Network
Conditions:
Opioid-use Disorder
Opioid Dependence
Eligibility:
All Genders
16-89 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT04664062
Start Date
May 13 2021
End Date
February 28 2026
Last Update
April 9 2024
Active Locations (2)
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1
University of Colorado
Denver, Colorado, United States, 80045
2
American Academy of Family Physicians National Research Network
Leawood, Kansas, United States, 66211