Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jun 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with opioid use disorder (OUD) by using a medication called extended-release buprenorphine (XR-BUP). The goal is to see if this low-dose treatment can be safe and effective for patients who are trying to overcome their addiction. If you are an adult aged 18 or older and have been diagnosed with OUD, you might be eligible to participate. To qualify, you need to have used illicit opioids recently and will need to provide a urine test that shows fentanyl, a type of opioid.

During the trial, you would spend five days in a hospital where you’ll receive care and monitoring. To help prevent withdrawal symptoms, you'll first receive fentanyl, followed by a single injection of XR-BUP. Throughout your stay, the medical team will keep a close eye on you to check for any withdrawal symptoms that might come up after the injection. It's important to note that this study is not yet recruiting participants, and certain conditions, such as a recent history of using other specific opioid treatments or having certain mental health issues, may prevent you from being able to join.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • English speaking adults aged 18 and above.
• • diagnosis of opioid use disorder.
• • Self-reporting use of illicit opioids in \>21 days in the prior 30 days.
• • Provide urine toxicology testing positive for fentanyl at baseline.
• Exclusion Criteria:
• • Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
• • Received buprenorphine or methadone treatment in prior 30 days.
• • Current diagnosis of alcohol or sedative/hypnotic use disorder.
• • Positive urine drug screen for benzodiazepines, alcohol and or methadone.
• • Physical dependence on alcohol or sedative/hypnotics.
• • Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent.
• • Have a history or diagnosis of Intracranial mass/bleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, heart failure.
• • Recent (within 6 months) head trauma, stroke, or myocardial infarction
• • Requiring treatment with opioids for acute or chronic pain.
• • History of hypersensitivity or allergy to buprenorphine or fentanyl.
• • 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.