An interventional study of sphenopalatine ganglion block in Opioid Use Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 22 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-10-30.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Other
Medication is the most efficacious treatment of an opioid use disorder, including methadone, buprenorphine, and naltrexone. However, many patients experience withdrawal symptoms, which prevents them from being successfully inducted onto medication for opioid use disorder. This study is a pilot study investigating whether blocking the SPG helps reduce withdrawal symptoms in OUD. This study does not involve treatment or induction onto medications. It is a proof of principal study only. We will recruit non-treatment seeking subjects with OUD who are admitted to the research unit for all procedures.
The sphenopalatine ganglion (SPG) is a collection of neurons involved in autonomic regulation (which refers to bodily processes that are automatic like heart rate and blood pressure). Blocking the SPG is used to treat disorders, such as migraines or cluster headaches (short, severe headaches that occur together). The procedure will be performed by a doctor (specialized in ear, nose throat surgery) and would first involve the application of numbing nasal spray to both nostrils, which lasts about two hours and might reduce smell during that time. This is followed by an injection of a stronger numbing agent (similar to the type used by dentists) to the nerve bundles in the back of the nasal passages (one side at a time) via a tool, known as an endoscope which is a rigid tube with a camera on the end. The procedure is not painful. Previous studies have shown that clonidine, which inhibits the autonomic nervous system, is helpful for reducing the symptoms of opioid withdrawal. However, the dosing of clonidine is limited by side effects (lowered blood pressure and heart rate) and compliance. Furthermore, withdrawal is among the most significant barriers to substance treatment and ultimately overcoming a substance use disorder. Thus, we would like to explore whether a more targeted intervention would improve rates of successful acute detoxification while overcoming the aforementioned challenges of systemic side effects and compliance issues observed with the use of oral agents.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 3 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
The sphenopalatine ganglion will be blocked with bipuvacaine for this study
Procedure: sphenopalatine ganglion block
The sphenopalatine ganglion will be blocked with bupivacaine for this study
enrollment: percent screened subjects who enroll
We will measure the percent of screened participants who agree to enroll as part of the feasibility study
Time frame: 4 weeks
retention: percent enrolled subjects who complete
We will measure the percent of enrolled participants who complete the study as part of the feasibility study
Time frame: 4 weeks
tolerability: percent adverse events, if any
We will measure the percent of adverse events in this feasibility study, if any measured with the CTCAE grading system (rate 0 to 5)
Time frame: 4 weeks
Plan to share: No
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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute