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A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use

RecruitingEARLY Phase 1Ages 18 Years - 65 YearsAllRachel R. Luba
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are: Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Investigators also seek to understand and explore: How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes. How blood levels of buprenorphine and its metabolite norbuprenorphine

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged 18 to 65 * Voluntarily seeking treatment for opioid use disorder (OUD) * Consistent use of fentanyl or other high potency synthetic opioids * Meets DSM-5 criteria for OUD with at least moderate severity * Able to provide written informed consent in English and willing to comply with study procedures Exclusion Criteria: * Meets DSM-5 criteria for another substance use disorder as the primary diagnosis * Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode) * Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis) * Buprenorphine or methadone treatment in the past 30 days * Known allergy, hypersensitivity or intolerance to buprenorphine * Pregnancy, lactation, or unwillingness to use adequate contraceptive methods * Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification * Liver function tests \> 2x the upper limit of normal * Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days
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What it tests

  • Buprenorphine + naloxone (Suboxone)
  • Buprenorphine Injection
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Where

1 site
Substance Treatment and Research Service
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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