A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder
Overview
- Phase
- Phase 4
- Intervention
- buprenorphine-naloxone
- Conditions
- Opioid Use Disorder
- Sponsor
- Montefiore Medical Center
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Use of FDA-approved medications for opioid use disorder treatment (within 7 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
Arms & Interventions
Low-dose initiation
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
Intervention: buprenorphine-naloxone
Treatment as usual
Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.
Intervention: buprenorphine-naloxone
Outcomes
Primary Outcomes
Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
Time Frame: 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 Outcomes
- Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol.(From baseline to day 8)
- Non-prescribed opioid use(From baseline to 6-week study visit)
- Number of participants who uptake buprenorphine treatment at 2 weeks(2-week study visit)
- Number of participants retained in buprenorphine treatment at 6 weeks(6-week study visit)
- Withdrawal severity(From baseline to 2-week study visit)
- Precipitated withdrawal(From baseline to 2-week study visit)
- Mild vs Mod-Severe Withdrawal symptoms(From baseline to 2-week study visit)