This study is not yet accepting patients

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

a study on Opioid Use Fentanyl

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Leslie W Suen, MD

Description

Summary

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.

Official Title

Improving Buprenorphine Initiation Among Individuals With Opioid Use Disorder Using Fentanyl

Keywords

Opioid Use Disorder, Fentanyl, Buprenorphine initiation, Low-dose initiation, Direct-to-inject initiation, Medication for opioid use disorder, Outpatient treatment for opioid use disorder, Opioid-Related Disorders, Buprenorphine, Sublocade, Naloxone Drug Combination Buprenorphine, Injectable buprenorphine, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets), Direct-to-inject (DTI)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Location

  • San Francisco Outpatient Buprenorphine Induction Clinic
    San Francisco California 94103 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07469501
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated