Opioid-use Disorder study: Buprenorphine/naloxone
Official title Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments
ClinicalTrials.gov ID: NCT04893525
What this study is testing
What is Buprenorphine/naloxone?
An investigational medication being studied for opioid‑use disorder.
Also referred to as Suboxone.
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 compares two ways of giving buprenorphine/naloxone: a small‑dose start that avoids withdrawal and a standard dose. It looks at how many people finish the first week of treatment and stay on therapy afterward.
- Who it's for
- Adults who are in the emergency department and have opioid‑use disorder and are willing to try medication for their addiction.
- What's involved
- Participants will be randomly given either a microdose or a standard dose package of buprenorphine/naloxone to take home. They will follow the dosing schedule at home and may have follow‑up visits or calls to check on progress.
- Time commitment
- The study lasts about one week of treatment, with follow‑up visits or phone calls afterward to see if participants remain on therapy.
- 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
- We will include ED patients ≥18 years of age with opioid use disorder who are being discharged from the ED.
- All patients will also be assessed by the treating physician or degree of clinical opioid withdrawal, based on the clinical opiate withdrawal scale...
You likely can't join if
- Active withdrawal at time of ED assessment (Clinical Opiate Withdrawal Score [COWS] \>12)
- Admitted to hospital
- Severe communication barriers that inhibit patients' understanding of study procedures and interventions
- Are taking opioids for cancer or palliative-care related indications
- Are deemed unsafe to approach by ED providers
- Incarceration
See the full eligibility criteria
- We will include ED patients ≥18 years of age with opioid use disorder who are being discharged from the ED.
- All patients will also be assessed by the treating physician or degree of clinical opioid withdrawal, based on the clinical opiate withdrawal scale (COWS) score.
- Active withdrawal at time of ED assessment (Clinical Opiate Withdrawal Score [COWS] \>12)
- Admitted to hospital
- Severe communication barriers that inhibit patients' understanding of study procedures and interventions
- Are taking opioids for cancer or palliative-care related indications
- Are deemed unsafe to approach by ED providers
- Incarceration
- Not a resident of the province in which they are seeking care (BC or Alberta)
- Actively receiving OAT, defined as having filled a prescription for one of the following medications in the 5 days prior to ED presentation: buprenorphine/naloxone, methadone, sustained release morphine, injectable...
- Prior enrollment in the study
- Known or suspected mechanical gastrointestinal obstruction (e.g., bowel obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any type).
- Suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
- Severe respiratory insufficiency.
- Severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
- Allergy to buprenorphine/naloxone
- Severe respiratory or liver dysfunction
- Concurrent withdrawal or intoxication from sedatives (e.g., alcohol, benzodiazepines)
- Active prescription for sedative medications (e.g., benzodiazepines, opioids)
- Use of monoamine oxidase inhibitors within the past 14 days
- Concerns that the patient is unable to safely store medications
- Pregnancy (we will obtain a point-of-care urine pregnancy test on all women of child-bearing age prior to enrollment)
The study team makes the final eligibility decision.
Where it is enrolling
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
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 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?
This study is enrolling now at Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada. 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.