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New treatment option for Opioid Use Disorder
Official title Low-dose Buprenorphine Initiation for Opioid Use Disorder
ClinicalTrials.gov ID: NCT05450718
What this study is testing
What is buprenorphine-naloxone?
buprenorphine-naloxone is an investigational medicine, being studied as a potential treatment for opioid use disorder.
Also referred to as buprenorphine microdosing, buprenorphine micro-induction.
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 purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 18 years or greater
- Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Ability to take sublingual medication
You likely can't join if
- Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or...
- Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Severe untreated mental illness, meaning psychosis or suicidality
- Presence of an acute or chronic medical condition that would make participation medically hazardous
- Pregnancy or lactation
- Known allergic reactions to buprenorphine or naloxone
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 18 years or greater
- Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Ability to take sublingual medication
- Willingness to adhere to the assigned buprenorphine initiation regimen
- Fluency in English or Spanish
- For participants of reproductive potential: agreement to use highly effective contraception during study participation
- Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone
- Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Severe untreated mental illness, meaning psychosis or suicidality
- Presence of an acute or chronic medical condition that would make participation medically hazardous
- Pregnancy or lactation
- Known allergic reactions to buprenorphine or naloxone
- Inability to consent due to cognitive impairment
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, 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 The Bronx, New York, 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.