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Prevention study for Opioid Use Disorder
Official title Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
ClinicalTrials.gov ID: NCT06316830
What this study is testing
What is Buprenorphine?
Buprenorphine is an investigational medicine, given as an once-daily, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg). The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- English-speaking
- Age 18 years-old or older
- Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
- Initiating or continuing buprenorphine for treatment of opioid use disorder
- History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus...
You likely can't join if
- Previous enrollment in the trial
- Incarcerated or in police custody\
- Pregnant
- Live outside of Rhode Island (RI)
- Unable to provide informed consent
- Allergy to Buprenorphine
See the full eligibility criteria
- English-speaking
- Age 18 years-old or older
- Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
- Initiating or continuing buprenorphine for treatment of opioid use disorder
- History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing...
- Previous enrollment in the trial
- Incarcerated or in police custody\
- Pregnant
- Live outside of Rhode Island (RI)
- Unable to provide informed consent
- Allergy to Buprenorphine
- Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \ Participants that become incarcerated/or in police custody during the study will be withdrawn.
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.