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 early on in treatment may influence treatment outcomes. How factors like craving and opioid withdrawal symptoms influence treatment outcomes. Participants will: Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine. Provide blood and urine samples while on the inpatient unit and at follow up. Complete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines/standard of care
Participants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving/tolerating a single 4/1 mg sublingual buprenorphine/naloxone dose
Substance Treatment and Research Service
New York, New York, United States
RECRUITINGPercentage of Days Abstinent from Opioids
Abstinence from Opioids (% days abstinent; continuous; longitudinal) during each week of the 4 week follow up period measured via the timeline follow back.
Time frame: 4 week follow up period
Sustained Relapse
Sustained relapse during the 4 week follow up period (binary), defined as 5 consecutive days of illicit opioid use reported on the timeline follow back at any point during the 4 week follow up period.
Time frame: 4 week follow up period
Time to Peak Clinical Opiate Withdrawal Scale (COWS) score
The time to peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (time-to-event/survival). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms.
Time frame: During the inpatient induction period (approximately 1 overnight stay)
Peak Clinical Opiate Withdrawal Scale (COWS) score
The peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (continuous). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms.
Time frame: During the inpatient induction period (approximately 1 overnight stay)
Dropout during induction
Dropout during the induction period (binary)
Time frame: During the inpatient induction period (approximately 1 overnight stay)
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