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New treatment option for Opioid Use Disorder
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?
Naloxone Hydrochloride 0.4 MG/ML is an investigational medicine, given as an injection under the skin, 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 goal of this clinical study is to evaluate a new treatment approach called symptom inhibited naloxone induction (SINI) for people with opioid use disorder. In this study, participants will receive small doses of intravenous (IV) naloxone at intervals until they feel mild opioid withdrawal symptoms.
- 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
- If participants meet any of the following exclusion criteria, they will be excluded from participation in the study:
- 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.
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. o Highly effective methods of birth control include hormonal contraceptives (e.g., combined oral contraceptives, patch...
- Willing and able to provide written informed consent for study participation.
- If participants meet any of the following exclusion criteria, they will be excluded from participation in the study:
- 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's taking place
- Vancouver, British Columbia, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. 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.