Using low-dose buprenorphine to treat opioid use disorder
Oral Buprenorphine as a Novel Low-Dose Induction Strategy for Individuals With Opioid Use Disorder
This study is testing if low doses of buprenorphine can help treat opioid use disorder in healthy volunteers by trying different ways of giving the medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06086275 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-dose buprenorphine on healthy volunteers to assess its potential as an induction strategy for opioid use disorder. Participants will undergo three separate inpatient visits where they will receive varying doses of buprenorphine, including an intravenous dose and two oral doses. The study employs a randomized, cross-over design to ensure that each participant experiences all dosing conditions, with naltrexone administered to prevent opioid dependence. Blood samples will be collected to analyze the pharmacokinetics of buprenorphine over a 24-hour period.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking adults aged 18 and older with a prior history of opioid use but currently in good physical health.
Not a fit: Patients with a current substance use disorder diagnosis or those requiring opioid analgesics during the trial 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: While there have been studies on buprenorphine for opioid use disorder, this specific low-dose induction strategy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking adults aged 18 and above. * In good physical health as determined by routine medical screening consisting of a complete physical exam, safety labs and EKG. * Baseline vital signs with HR between 60 and 100, SBP between 90 and 160mmHg, and respiratory rate between 12 and 20 breaths per minute. * Prior personal history of opioid use, therapeutic or non-therapeutic in past the 12 months. Exclusion Criteria: * DSM-5 diagnosis of any substance use disorder excluding tobacco. * Presence of any alcohol, cannabis, opioids (including methadone, buprenorphine) or any other illicit substances on urine toxicology at any study visit, including cocaine, amphetamines, and benzodiazepines. * Receiving treatment with opioid analgesic in last 60 days, or anticipate requiring opioids during the proposed trial, or up to 30 days after the trial completion * Baseline PHQ-9 or GAD7 \> 10 (i.e. moderate depression/anxiety) * History of chronic pain * Psychotic disorder, active suicidality or homicidally, or any psychiatric condition that impair ability to provide informed consent. * History of hypersensitivity or allergy to buprenorphine or naltrexone * Pregnant or breastfeeding. * Liver function test greater than 3 times upper normal limit. * Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Joji Suzuki, MD
- Email: jsuzuki2@bwh.harvard.edu
- Phone: 6177325752
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.