Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
Recruiting
Phase 4
Interventional Study
Opioid Use Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- Pouya Azar · Other
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About This Trial
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. At this point, they will be given buprenorphine/naloxone under the tongue to help with the withd…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
To be eligible for this study, participants must fulfill all the following inclusion criteria:
* 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 opio…
Contacts