Low-dose buprenorphine for treating opioid use disorder
A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder
This study is testing if starting treatment for opioid use disorder with low-dose buprenorphine is safe and effective compared to standard treatment, while tracking participants' symptoms and cravings using their mobile phones.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05450718 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of initiating treatment for opioid use disorder with low-dose buprenorphine. Participants will be randomly assigned to either an 8-day low-dose buprenorphine initiation protocol or standard treatment. Throughout the study, participants will use mobile phones to provide real-time data on their withdrawal symptoms, anxiety, cravings, and substance use through electronic Ecological Momentary Assessment (EMA) technology. The study will involve visits at baseline and at weeks 2 and 4 to monitor progress and outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of opioid use disorder who are willing to comply with study procedures.
Not a fit: Patients currently using FDA-approved medications for opioid use disorder treatment or those with severe mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for initiating treatment in patients with opioid use disorder.
How similar studies have performed: Other studies have shown promise with low-dose buprenorphine approaches, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Any gender, aged 18 years or greater 4. Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria) 5. Ability to take sublingual medication 6. Willingness to adhere to the assigned buprenorphine initiation regimen 7. Fluency in English or Spanish 8. For participants of reproductive potential: agreement to use highly effective contraception during study participation Exclusion Criteria: 1. Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone 2. Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria) 3. Severe untreated mental illness, meaning psychosis or suicidality 4. Presence of an acute or chronic medical condition that would make participation medically hazardous 5. Pregnancy or lactation 6. Known allergic reactions to buprenorphine or naloxone 7. Inability to consent due to cognitive impairment
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin T Hayes, MD, MS, MPH — Montefiore Medical Center
- Study coordinator: Benjamin T Hayes, MD, MS, MPH
- Email: bhayes@montefiore.org
- Phone: 4156700850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.