Opioid Use Disorder study: Naloxone Hydrochloride
Official title Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
ClinicalTrials.gov ID: NCT07439549
What this study is testing
What is Naloxone Hydrochloride 0.4 MG/ML?
This is an investigational medicine being studied as a potential treatment for opioid use disorder. It is designed to block opioid receptors in the body to reverse the effects of opioids.
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
- This study checks if a new way to start buprenorphine is safe, workable, and comfortable for people with opioid use disorder.
- Who it's for
- People living with opioid use disorder who are ready to start treatment.
- What's involved
- Participants receive small doses of naloxone until mild withdrawal symptoms appear, then take buprenorphine under the tongue. They may also choose to get a long-acting buprenorphine injection.
- Time commitment
- The study involves specific treatment steps and follow-up visits to monitor safety and comfort.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- To be eligible for this study, participants must fulfill all the following
- 19 years of age or older.
- Opioid use disorder as confirmed by DSM 5 diagnostic criteria.
- Clinical indication to start OAT with buprenorphine.
- Willingness to tolerate mild opioid withdrawal precipitated by naloxone, expected to last less than 20 minutes.
You likely can't join if
- Diagnosis of severe medical or psychiatric conditions contraindicated for naloxone or buprenorphine.
- Concomitant use of medications with drug-drug interactions with buprenorphine, unless alternative treatment options are less appropriate and a...
- Known allergy or sensitivity to naloxone or buprenorphine.
- Use of BUP/NLX within the past 9 days.
- Use of BUP-XR within the past 43 weeks.
- Previous participation in this study (previous receipt of SINI in a clinical setting is not exclusionary).
See the full eligibility criteria
- To be eligible for this study, participants must fulfill all the following
- 19 years of age or older.
- Opioid use disorder as confirmed by DSM 5 diagnostic criteria.
- Clinical indication to start OAT with buprenorphine.
- Willingness to tolerate mild opioid withdrawal precipitated by naloxone, expected to last less than 20 minutes.
- Willing and able to have and maintain IV access for the duration of the SINI
- If of childbearing potential and elected BUP-XR, agree to use an effective method of birth control.
- Willing and able to provide written informed consent for study participation.
- Diagnosis of severe medical or psychiatric conditions contraindicated for naloxone or buprenorphine.
- Concomitant use of medications with drug-drug interactions with buprenorphine, unless alternative treatment options are less appropriate and a risk-benefit assessment has been discussed and recommended by the...
- Known allergy or sensitivity to naloxone or buprenorphine.
- Use of BUP/NLX within the past 9 days.
- Use of BUP-XR within the past 43 weeks.
- Previous participation in this study (previous receipt of SINI in a clinical setting is not exclusionary).
- Currently pregnant or breastfeeding.
- COWS ≥ 8
The study team makes the final eligibility decision.
Where it is enrolling
- 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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at 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.