Fentanyl, Opioid Use Disorder
Conditions
Keywords
Buprenorphine initiation, Low-dose initiation, Direct-to-inject initiation, Medication for opioid use disorder, Outpatient treatment for opioid use disorder
Brief 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.
Interventions
DRUGInjectable 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)
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
Sponsors
University of California, San Francisco
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous retention in outpatient buprenorphine treatment by day 90 | 90 days | 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 |
| Self-reported protocol satisfaction at day 7 | 7 days | Patient-reported satisfaction with buprenorphine initiation protocol measured by Likert-scale satisfaction survey administered on day 7 follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per protocol and as-treated retention in outpatient buprenorphine treatment at day 90 | 90 days | 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 |
| Successful buprenorphine initiation within first 7 days | 7 days | 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. |
| Fentanyl use during days 1-7 determiend by urinary drug screen | 7 days | Concurrent fentanyl use during days 1-7 following buprenorphine initiation, determined by urinary drug screen at day 7 follow-up visit. |
| Fentanyl use during days 8-30 determined by urinary drug screen | 30 days | Concurrent fentanyl use during days 8-30 following buprenorphine initiation, determined by urinary drug screen at day 30 follow-up visit. |
| Fentanyl use during days 31-90 determined by urinary drug screen | 90 days | Concurrent fentanyl use during days 31-90 following buprenorphine initiation, determined by urinary drug screen at day 90 follow-up visit. |
| Self-reported concurrent fentanyl use during days 1-7 | 7 days | Concurrent fentanyl use during days 1-7 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 7 follow-up visit. |
| Self-reported concurrent fentanyl use during days 8-30 | 30 days | Concurrent fentanyl use during days 8-30 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 30 follow-up visit. |
| Self-reported concurrent fentanyl use during days 31-90 | 90 days | Concurrent fentanyl use during days 31-90 following buprenorphine initiation, determined by self-reported Timeline Follow Back survey at day 90 follow-up visit. |
| Self-reported number of days of fentanyl use in first 7 days | 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. |
| Self-reported number of days of concurrent fentanyl use during first 30 days | 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. |
| Self-reported number of days of concurrent fentanyl use during days 31-90 | 90 days | 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. |
| Baseline withdrawal symptoms, measured with COWS | 0 days | At baseline, a Clinical Opioid Withdrawal Score (COWS) survey will be administered and confirmed with the prescribing clinician. |
| Standardized self-reported daily withdrawal symptom severity over days 1-7 by SOWS | 7 days | 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. |
| Standardized self-reported peak withdrawal symptom severity during days 1-7 by SOWS | 7 days | 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. |
| Standardized self-reported daily craving symptom severity over days 1-7 by VAS | 7 days | 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. |
| Standardized self-reported peak craving symptom severity during days 1-7 by VAS | 7 days | 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. |
Countries
United States
Contacts
CONTACTLeslie W Suen, MD
PRINCIPAL_INVESTIGATORLeslie W Suen, MD
University of California, San Francisco
Outcome results
None listed