Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA060329-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose initiation (LDI) | Active Comparator | Participants start 0.5mg sublingual buprenorphine (Subutex) and gradually increase by 0.5-1.0mg daily for 7 days |
|
| Direct-to-inject (DTI) | Experimental | Participants receive 8-32mg long-acting injectable buprenorphine (Brixadi or Sublocade) on day 1, followed by monthly injections as discussed with the provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable buprenorphine | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous retention in outpatient buprenorphine treatment by day 90 | Receiving continuous treatment with buprenorphine sublingual prescriptions or injections administrations during the 90 days of follow up post-randomization as intended-to-treat. A period without buprenorphine treatment ≥8 days will be considered treatment discontinuation. Number of days of continuous treatment with the site clinician prescribing sublingual or injectable buprenorphine treatment during the 90 days post-randomization among RCT participants | 90 days |
| Self-reported protocol satisfaction at day 7 | Patient-reported satisfaction with buprenorphine initiation protocol measured by Likert-scale satisfaction survey administered on day 7 follow-up visit | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Per protocol and as-treated retention in outpatient buprenorphine treatment at day 90 | Similar to the primary intention to treat analysis, though we will be analyzing data and individuals based on actual protocol received and treated, rather than assigned treatment at randomization | 90 days |
| Successful buprenorphine initiation within first 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall number of adverse events in each arm within 30 days, and by relatedness to study intervention | Number of adverse events within 30 days, coded by body system and MedDRA classification. All adverse events reported by participants or identified through clinical documentation will be recorded and categorized by severity, duration, and relationship to the study intervention. | 30 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leslie W Suen, MD | Contact | 628-206-6007 | leslie.suen@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leslie W Suen, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Outpatient Buprenorphine Induction Clinic | San Francisco | California | 94103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37579105 | Background | 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. | |
| 40183345 | Background | 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. |
Not provided
Not provided
IPD will not be shared outside of this study's research team.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) | Drug | 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 |
|
|
Defined as successfully completing buprenorphine initiation. For LDI treatment arm, this means self-reported completion of initiation "blister pack" during Days 1-6 at clinical follow up and pick up of buprenorphine refill based on prescription data. For DTI, this means administration of initial weekly BRIXADI injection and subsequent monthly BRIXADI or SUBLOCADE buprenorphine injection within 7 days of the initial weekly injection. |
| 7 days |
| Fentanyl use during days 1-7 determiend by urinary drug screen | Concurrent fentanyl use during days 1-7 following buprenorphine initiation, determined by urinary drug screen at day 7 follow-up visit. | 7 days |
| Fentanyl use during days 8-30 determined by urinary drug screen | Concurrent fentanyl use during days 8-30 following buprenorphine initiation, determined by urinary drug screen at day 30 follow-up visit. | 30 days |
| Fentanyl use during days 31-90 determined by urinary drug screen | Concurrent fentanyl use during days 31-90 following buprenorphine initiation, determined by urinary drug screen at day 90 follow-up visit. | 90 days |
| Self-reported concurrent fentanyl use during days 1-7 | Concurrent fentanyl use during days 1-7 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 7 follow-up visit. | 7 days |
| Self-reported concurrent fentanyl use during days 8-30 | Concurrent fentanyl use during days 8-30 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 30 follow-up visit. | 30 days |
| Self-reported concurrent fentanyl use during days 31-90 | Concurrent fentanyl use during days 31-90 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 90 follow-up visit. | 90 days |
| Self-reported number of days of fentanyl use in first 7 days | Number of days of concurrent fentanyl use during days 1-7 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 7 follow-up visit. | 7 days |
| Self-reported number of days of concurrent fentanyl use during first 30 days | Number of days of concurrent fentanyl use during days 8-30 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 30 follow-up visit. | 30 days |
| Self-reported number of days of concurrent fentanyl use during days 31-90 | Number of days of concurrent fentanyl use during days 31-90 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 90 follow-up visit. | 90 days |
| Baseline withdrawal symptoms, measured with COWS | At baseline, a Clinical Opioid Withdrawal Score (COWS) survey will be administered and confirmed with the prescribing clinician. | 0 days |
| Standardized self-reported daily withdrawal symptom severity over days 1-7 by SOWS | During each of the first 7 days, participants will rate the severity of withdrawal symptoms using standardized Likert-type response scales in a daily diary. Items will be adapted from the validated Subjective Opioid Withdrawal Scale [SOWS] (from 0-4, with 0 being not at all and 4 being extreme) to assess for subjective withdrawal symptoms to minimize participant burden while ensuring reliable data capture. | 7 days |
| Standardized self-reported peak withdrawal symptom severity during days 1-7 by SOWS | During each of the first 7 days, participants will rate the severity of withdrawal symptoms using standardized Likert-type response scales in a daily diary. Items will be adapted from the validated Subjective Opioid Withdrawal Scale [SOWS] (from 0-4, with 0 being not at all and 4 being extreme) to assess for subjective withdrawal symptoms to minimize participant burden while ensuring reliable data capture. We will calculate peak withdrawal symptoms during the 7-day period. | 7 days |
| Standardized self-reported daily craving symptom severity over days 1-7 by VAS | During each of the first 7 days, participants will rate the severity of craving symptoms using standardized Likert-type response scales in a daily diary. Items will be adapted from the validated Visual Analog Scale [VAS] (from 0-100, with 0 being none at all and 100 being strongest craving ever) to assess for subjective craving symptoms to minimize participant burden while ensuring reliable data capture. | 7 days |
| Standardized self-reported peak craving symptom severity during days 1-7 by VAS | During each of the first 7 days, participants will rate the severity of craving symptoms using standardized Likert-type response scales in a daily diary. Items will be adapted from the validated Visual Analog Scale [VAS] (from 0-100, with 0 being none at all and 100 being strongest craving ever) to assess for subjective craving symptoms to minimize participant burden while ensuring reliable data capture. We will calculate the peak craving severity during the first 7 days. | 7 days |
| Number of serious adverse events in each arm in 30 days, and by relatedness to the study intervention | Number of serious adverse events within 30 days, coded by body system and MedDRA classification. All adverse events reported by participants or identified through clinical documentation will be recorded and categorized by severity, duration, and relationship to the study intervention. | 30 days |
| Number of ED visits and hospital admissions in each arm in 30 days, and by relatedness to study intervention | Number of emergency department visits and hospital admissions within 30 days, coded by body system and MedDRA classification. All adverse events reported by participants or identified through clinical documentation will be recorded and categorized by severity, duration, and relationship to the study intervention. | 30 days |
| Number of fatal opioid overdose events occurring during the 90-day follow-up period, by study arm | Documented deaths due to opioid overdose during the 90-day follow-up period will be identified through the EHR and, if available, linkage to external death records. | 90 days |
| Treatment Fidelity and Protocol Adherence | Study staff will track whether the assigned LDI or DTI protocol was delivered as intended, including any deviations from the dosing schedule or logistical challenges encountered | 90 days |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| C000627685 | Sublocade |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided