Purpose

The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years of age or older; - Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD; - Are initiating a new MOUD treatment episode

Exclusion Criteria

  • Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a "bridge" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification). - Known contraindication to methadone or BUP - Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment - Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician - Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician - Be unable or unwilling to provide reliable locator information including 2 or more contacts in addition to themselves - Be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to BUP or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the EMR and state's prescription drug monitoring program - Have previously enrolled in CTN-0131 - Currently enrolled in another research study which will conflict with study procedures - Are currently in jail, prison or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities - Unable to conduct research assessments in English as determined by Site PI or their designee.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions. Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated. Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Office-based methadone
Under special Drug Enforcement Administration (DEA) exception, Clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy which also has an exception to do so. All randomized controlled trial (RCT) participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).
  • Drug: Methadone
    Drug: Methadone Possible formulations: 10 and 40 mg tablets
Active Comparator
Office-based buprenorphine (BUP)
Clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). All RCT participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).
  • Drug: Buprenorphine (BUP)
    Drug: Buprenorphine (BUP) Possible formulations: A. Buprenorphine 225 mcg to 24 mg 225 mcg to 32 mg per day B. Buprenorphine (Extended release) 300 mg q 28 days (Sublocade) 100 mg q 28 days (Sublocade) 8 mg q 7 days (Brixadi) 16 mg q 7 days (Brixadi) 24 mg q 7 days (Brixadi) 32 mg q 7 days (Brixadi) 64 mg q 7 28 days (Brixadi) 96 mg q 7 28 days (Brixadi) 128 mg q 7 28 days (Brixadi)

Recruiting Locations

Officed Based Addiction Treatment Program, Boston Medical Center
Boston, Massachusetts 02118
Contact:
Emily Neimeyer
857-283-7620
EMBOSS@bmc.org

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Jessica Research Associate
203-785-6821
j.mckenzie@yale.edu

Detailed Description

This study is a randomized, pragmatic hybrid type 1 effectiveness/implementation multisite (approximately 6 sites) trial to determine whether office-based methadone with pharmacy administration and/or dispensing or buprenorphine (BUP) results in greater treatment retention in approximately 600 patients with opioid use disorder (OUD). This trial will also identify implementation barriers, facilitators and acceptability at the patient, provider and health-systems level for office-based methadone with pharmacy administration and/or dispensing.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.