Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation (COPILOT)

University of California San Francisco (UCSF)

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: Fentanyl; Opioid Use Disorder

Treatments: Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets); Drug: Injectable buprenorphine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07469501

1K23DA060329-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD) who use fentanyl. This study aims to:

1. Compare effectiveness of each strategy on treatment retention in a real world, clinical setting, and
2. Assess differences between strategies in patient-reported outcomes, including withdrawal symptoms, cravings, drug use, treatment satisfaction, and overall acceptability.

Participants will:

1. Be randomized to initiate buprenorphine via a low-dose initiation or direct-to-inject protocol at an outpatient buprenorphine clinic,
2. Keep a diary of craving and withdrawal symptoms for the first 7 days after initiation, and
3. Visit the outpatient clinic 7, 30, and 90 days after initiation for urinary drug screen and follow-up surveys.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years of age at Visit 1.
• Documentation of an OUD diagnosis as evidenced by meeting two or more of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) Criteria for Opioid Use Disorder
• Self-reported daily use of fentanyl ≥ 5 out of the past 7 days at baseline,
• Fentanyl-positive urine drug screening at baseline,
• Interest in stopping or reducing fentanyl use,
• Publicly insured through San Francisco Medicaid or Medicare and therefore able receive buprenorphine prescription dispensing through Community Behavioral Health Services (CBHS) Pharmacy

Exclusion criteria

• Currently nursing, pregnant, or anticipating pregnancy in the next 6 months
• Methadone-positive urine drug screening at baseline
• Buprenorphine-positive urine drug screening at baseline
• Be unable to provide any locator or contact information at least one contact in addition to themselves
• Any pending legal action that could prevent participation in study activities
• Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data (e.g., acute psychosis), or cognitive impairment (e.g., dementia)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Low-dose initiation (LDI)

Active Comparator group

Description:

Participants start 0.5mg sublingual buprenorphine (Subutex) and gradually increase by 0.5-1.0mg daily for 7 days

Treatment:

Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)

Direct-to-inject (DTI)

Experimental group

Description:

Participants receive 8-32mg long-acting injectable buprenorphine (Brixadi or Sublocade) on day 1, followed by monthly injections as discussed with the provider

Treatment:

Drug: Injectable buprenorphine