Trial comparing treatments for Opioid Use Disorder
Official title A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
ClinicalTrials.gov ID: NCT04375033
What this study is testing
What is Sublingual buprenorphine with naloxone?
This is an investigational daily medicine being studied as a treatment for opioid use disorder. It is designed to bind to opioid receptors in the brain to help reduce cravings and withdrawal symptoms.
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 study will see if the injectable form keeps Veterans in treatment longer and helps them stay opioid‑free compared to the standard daily pill.
- Who it's for
- Veterans who have opioid use disorder and are willing to participate in a 52‑week study.
- What's involved
- Participants will receive either the 28‑day injectable or daily oral buprenorphine, attend regular clinic visits, and undergo tests for substance use, health conditions, and other health measures.
- Time commitment
- The study lasts 52 weeks, with visits and tests scheduled throughout that period.
- Phase 4: studies an already-approved treatment
- Time commitment: about 10 years
- 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
- Has used opioids within 30 days prior to consent or within 30 days prior to entry into a supervised setting -- e.g., opioid use within the 30 days...
- Have started or are in the process of starting on Medications for Opioid Use Disorder (MOUD) via clinical induction on SL-BUP/NLX
- Meets DSM-5 criteria for moderate to severe opioid use disorder (OUD) based on the Mini-International Neuropsychiatric Interview
- Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy
You likely can't join if
- For Veterans of childbearing potential (a premenopausal person capable of becoming pregnant), pregnancy, breastfeeding, and/or failure to practice an...
- Failure to reach maintenance dose of 4 milligrams (mg) - 32mg SL-BUP/NLX in 45 days or less
- Taking a form of prescribed maintenance Medications for Opioid Use Disorder (MOUD), e.g., methadone, buprenorphine or XR-NTX) continuously \>45 days...
- Has a history of significant adverse effects from buprenorphine and/or naloxone
- Has experienced (within the past 2 weeks) recent suicidal or homicidal ideation that requires acute treatment or hospitalization
- Is unwilling or unable to provide consent
See the full eligibility criteria
- Has used opioids within 30 days prior to consent or within 30 days prior to entry into a supervised setting -- e.g., opioid use within the 30 days prior to recent (\<30 days) incarceration, entry into a detoxification...
- Have started or are in the process of starting on Medications for Opioid Use Disorder (MOUD) via clinical induction on SL-BUP/NLX
- Meets DSM-5 criteria for moderate to severe opioid use disorder (OUD) based on the Mini-International Neuropsychiatric Interview
- Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy
- For Veterans of childbearing potential (a premenopausal person capable of becoming pregnant), pregnancy, breastfeeding, and/or failure to practice an effective method of birth control
- Failure to reach maintenance dose of 4 milligrams (mg) - 32mg SL-BUP/NLX in 45 days or less
- Taking a form of prescribed maintenance Medications for Opioid Use Disorder (MOUD), e.g., methadone, buprenorphine or XR-NTX) continuously \>45 days prior to randomization
- Has a history of significant adverse effects from buprenorphine and/or naloxone
- Has experienced (within the past 2 weeks) recent suicidal or homicidal ideation that requires acute treatment or hospitalization
- Is unwilling or unable to provide consent
- Meets criteria for current (past month) DSM-5 severe sedative hypnotic use disorder based on the MINI Sedative, Hypnotic, or Anxiolytic Use Disorder (SHUD) module
- Anuria and/or dialysis
- Current moderate to severe COVID-19 symptoms with a risk of intubation or critical illness
- Medical, psychiatric, behavioral, or logistical condition which, in the judgement of the Local Site Investigator (LSI) or Co-Investigator (Co-I), requires a higher level of acute care and/or makes it unlikely the...
- Is actively participating in an treatment clinical trial for which a waiver of dual-enrollment with CSP #2014 has not been obtained
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Long Beach, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- West Haven, Connecticut, United States
- Wilmington, Delaware, United States
- Bay Pines, Florida, United States
- Gainesville, Florida, United States
- Dayton, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Hampton, Virginia, United States
- Salem, Virginia, United States
- Seattle, Washington, United States
- Huntington, West Virginia, United States
- Milwaukee, Wisconsin, 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
This study is enrolling now at Phoenix, Arizona, United States; Long Beach, California, United States; Palo Alto, California, United States; San Francisco, California, United States; West Haven, Connecticut, United States; Wilmington, Delaware, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.