Low-dose Buprenorphine Initiation for Opioid Use Disorder
- Conditions
- Opioid Use Disorder
- Interventions
- Drug: buprenorphine-naloxone
- Registration Number
- NCT05450718
- Lead Sponsor
- Montefiore Medical Center
- Brief Summary
The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.
- Detailed Description
After being informed about the study and potential risks, all participants will be given written informed consent. Eligible participants will be randomized in a 1:1 ratio to an 8-day low-dose buprenorphine initiation protocol or treatment as usual, and conduct study visits at baseline and weeks 2 and 4. The investigators will also provide participants with mobile phones to collect real-time data on withdrawal, anxiety, craving and substance use through electronic Ecological Momentary Assessment (EMA) technology.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 18 years or greater
- Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Ability to take sublingual medication
- Willingness to adhere to the assigned buprenorphine initiation regimen
- Fluency in English or Spanish
- For participants of reproductive potential: agreement to use highly effective contraception during study participation
- Use of FDA-approved medications for opioid use disorder treatment (within 14 days prior to screening), including methadone, buprenorphine, or naltrexone
- Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Severe untreated mental illness, meaning psychosis or suicidality
- Presence of an acute or chronic medical condition that would make participation medically hazardous
- Pregnancy or lactation
- Known allergic reactions to buprenorphine or naloxone
- Inability to consent due to cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose initiation buprenorphine-naloxone Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone (bup-nx) according to an at-home, 8-day protocol (below). Participants in the low-dose buprenorphine initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone. Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours Treatment as usual buprenorphine-naloxone Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.
- Primary Outcome Measures
Name Time Method Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial. At baseline study visit (time zero) This pilot study is designed to establish the feasibility of a future, full-powered clinical trial. The primary question this study seeks to answer is whether primary care patients with opioid use disorder are willing to enroll in a clinical trial of low-dose inductions. The study will aim to enroll 25% of subjects who are assessed. "Assessed" is defined as having been referred to the study staff. Enrollment is defined as having been randomized to a treatment arm.
- Secondary Outcome Measures
Name Time Method Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol. From baseline to day 8 This pilot study will seek to answer whether participants of a clinical trial adhere to a low-dose buprenorphine-naloxone (bup-nx) initiation protocol. The study aims to achieve 80% of study participants meeting adequate fidelity to the low-dose study protocol. Adequate fidelity is defined as meeting all of the following:
1. First dose is a low dose (defined as less than 1-.25mg bup-nx) (yes/no),
2. Daily bup-nx dose equivalent to assigned daily dose: For the first 7 days the reported total daily bup-nx dose is within the prespecified assigned daily dose limit,
3. Variability: Each day's daily dose is increased from the prior daily dose (within daily limits) (yes/no).
Measured using once daily participant self-report through mobile data collection technology.Non-prescribed opioid use From baseline to 6-week study visit The mean number of days of non-prescribed opioid use, defined as self-reported use of heroin, fentanyl, or non-prescribed opioid analgesics in the prior 14 days using an adapted version of the Addiction Severity Index. Will be reported for each arm at the 6-week visit (continuous).
Number of participants who uptake buprenorphine treatment at 2 weeks 2-week study visit Uptake is defined as having a positive urine drug test (UDT) for buprenorphine at the 2-week study visit (dichotomous, yes/no).
Number of participants retained in buprenorphine treatment at 6 weeks 6-week study visit 6-week retention is defined as having an active buprenorphine prescription and buprenorphine-positive UDT at the 6-week visit
Withdrawal severity From baseline to 2-week study visit Measured using the Subjective Opioid Withdrawal Score, a 16-item scale based on symptom severity (from 0=Not at all, to 4=extremely). Multilevel mixed-linear effects models will be used to assess between arms.
Precipitated withdrawal From baseline to 2-week study visit The percentage of participants who experience precipitated withdrawal during the first 2 weeks of initiation. Defined as withdrawal symptoms that get markedly worse within 90 minutes of taking buprenorphine-naloxone dose. Markedly worse will be defined as a change in 10 points on Subjective Opioid Withdrawal Score (SOWS) severity, or as determined by a study clinician. SOWS is a 16-item scale based on symptom severity (from 0=Not at all, to 4=extremely, yielding a possible overall range from 0-64). Precipitated withdrawal is expected only during periods of increasing buprenorphine-naloxone dose titrations: for the low-dose protocol precipitated withdrawal could occur from dose 1 - 13; for the treatment as usual protocol precipitated withdrawal could occur from dose 1 - 5. SOWS will be collected 5 times/day using daily mobile data collection entries.
Mild vs Mod-Severe Withdrawal symptoms From baseline to 2-week study visit The proportion of severe vs mild-moderate buprenorphine-related withdrawal events between study arms will be assessed using the using the Subjective Opioid Withdrawal Score, a 16-item scale based on symptom severity (from 0=Not at all, to 4=extremely). The 16 items are summed with a score of 1-10 representing mild withdrawal, 11-20 as moderate withdrawal, and \>/= 21 as severe withdrawal.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States