Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Injectable buprenorphine, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets).
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Fentanyl. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Buprenorphine Initiation Among Individuals With Opioid Use Disorder Using Fentanyl
Overview
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.
Interventions
- Drug Injectable buprenorphine
Starting dose (8-32mg) of long-acting injectable buprenorphine (Brixadi or Sublocade) on day 1, followed by monthly maintenance doses (e.g., 128mg Brixadi or 300mg Sublocade) - Drug Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Starting dose (0.5mg) of sublingual buprenorphine tablets in blister packs (Brixadi or Sublocade) on day 1, followed by 0.5-1.0mg daily increases in week 1 and maintenance dosing based on shared decision-making with provider
Primary outcome measures
- Continuous retention in outpatient buprenorphine treatment by day 90 [Time frame: 90 days]
- Self-reported protocol satisfaction at day 7 [Time frame: 7 days]
Secondary outcome measures (12)
- Per protocol and as-treated retention in outpatient buprenorphine treatment at day 90 [Time frame: 90 days]
- Successful buprenorphine initiation within first 7 days [Time frame: 7 days]
- Fentanyl use during days 1-7 determiend by urinary drug screen [Time frame: 7 days]
- Fentanyl use during days 8-30 determined by urinary drug screen [Time frame: 30 days]
- Fentanyl use during days 31-90 determined by urinary drug screen [Time frame: 90 days]
- Self-reported concurrent fentanyl use during days 1-7 [Time frame: 7 days]
- Self-reported concurrent fentanyl use during days 8-30 [Time frame: 30 days]
- Self-reported concurrent fentanyl use during days 31-90 [Time frame: 90 days]
- Self-reported number of days of fentanyl use in first 7 days [Time frame: 7 days]
- Self-reported number of days of concurrent fentanyl use during first 30 days [Time frame: 30 days]
- Self-reported number of days of concurrent fentanyl use during days 31-90 [Time frame: 90 days]
- Baseline withdrawal symptoms, measured with COWS [Time frame: 0 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- San Francisco Outpatient Buprenorphine Induction Clinic — San Francisco
Publications
- Noel M, Abbs E, Suen L, Samuel L, Dobbins S, Geier M, Soran CS. The Howard Street Method: A Community Pharmacy-led Low Dose Overlap Buprenorphine Initiation Protocol for Individuals Using Fentanyl. J Addict Med. 2023 Jul-Aug 01;17(4):e255-e261. doi: 10.1097/ADM.0000000000001154. Epub 2023 Feb 17. PMID 37579105
- Rosenwohl-Mack S, Suen LW, Logan AA, Peterson D, Snyder HR. Outpatient Initiation of 7-Day Injectable Buprenorphine: A Direct-to-Inject Case Series. Subst Use Addctn J. 2025 Oct;46(4):1064-1069. doi: 10.1177/29767342251330412. Epub 2025 Apr 4. PMID 40183345
Identifiers
NCT: NCT07469501 · 1K23DA060329-01 · 1K23DA060329-01