Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.

Part of paid clinical trials in Oakland, California.

Sponsor
Yale University
Study ID
NCT06323824
Phase
PHASE4
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Methadone — DRUG
    Drug: Methadone Possible formulations: 10 and 50 mg tablets
  • Buprenorphine (BUP) — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jun 4, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).

Primary Outcome Measure

Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants. [ Time Frame: up to Day 168 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Highland Hospital Bridge Clinic at Alameda Health SystemOaklandCalifornia94602
Jhoselyn Pineda
[email protected]
(510)214-3649
Monish Ullal, MD (PRINCIPAL_INVESTIGATOR)
Outpatient Buprenorphine Induction Clinic, University of California, San FranciscoSan FranciscoCalifornia94103
Kristina Toma
[email protected]
415-254-0398
Paula Lum, MD (PRINCIPAL_INVESTIGATOR)
Andy Tompkins, MD (PRINCIPAL_INVESTIGATOR)
Christine Soran, MD (SUB_INVESTIGATOR)
Rapid Start Clinic, Kaiser Permanente ColoradoDenverColorado80205
Jennifer Barrow
[email protected]
(303)-739-3666
Ingrid Binswanger, MD (PRINCIPAL_INVESTIGATOR)
Officed Based Addiction Treatment Program, Boston Medical CenterBostonMassachusetts02118
Emily Oot
[email protected]
857-283-7620
Zoe Weinstein, MD (PRINCIPAL_INVESTIGATOR)
Hennepin Healthcare Addiction MedicineMinneapolisMinnesota55415
Dat Nguyen
[email protected]
(763) 568-2785
Gavin Bart, MD (PRINCIPAL_INVESTIGATOR)
Marshall University Division of Addiction Sciences P.R.O.A.C.THuntingtonWest Virginia25703
Brynn M Taylor
[email protected]
740-302-0845
Zachary Hansen, MD (PRINCIPAL_INVESTIGATOR)
Todd Davies, PhD (SUB_INVESTIGATOR)

Find similar trials in Oakland, CA

By research site
Highland Hospital Bridge Clinic at Alameda Health System· Oakland, CAOutpatient Buprenorphine Induction Clinic, University of California, San Francisco· San Francisco, CARapid Start Clinic, Kaiser Permanente Colorado· Denver, COOfficed Based Addiction Treatment Program, Boston Medical Center· Boston, MAHennepin Healthcare Addiction Medicine· Minneapolis, MNMarshall University Division of Addiction Sciences P.R.O.A.C.T· Huntington, WV

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