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Induction and Maintenance on Buprenorphine in Opioid Use Disorder: Investigation of a peripheral nerve block for autonomic dysfunction

Award Number: R21DA066044
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2028

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Induction and Maintenance on Buprenorphine in Opioid Use Disorder: Investigation of a peripheral nerve block for autonomic dysfunction - Project Summary: The opioid epidemic continues to evolve, with high-potency synthetic opioids (HPSO), such as fentanyl, driving recent increases in the US overdose death rate. The aim of this study is to test the impact of blocking the sphenopalatine ganglion (SPG) as an adjunctive treatment to buprenorphine maintenance. The SPG is a large autonomic ganglion that can be blocked with a local anesthetic using minimal equipment. SPG blocks have been used clinically for decades to treat refractory migraine and cluster headache. This study proposes to enroll 40 individuals with opioid use disorder (OUD) who test positive for HPSO use. All participants will receive standard treatment with transmucosal buprenorphine and will be randomized to an active versus sham SPG block. The first SPG block will be delivered just prior to induction onto buprenorphine. After that, the SPG block will be performed weekly over the course of this 8-week study. The primary outcome measures will be weekly opioid withdrawal symptoms as measured by the clinical opiate withdrawal scale and treatment acceptability as measured by adherence to the weekly SPG procedure. The primary purpose of this proposed R21 is to estimate the 95% confidence interval for the treatment effect size between active and sham SPG block, for purpose of planning future studies, which will be done using confidence interval methodology. The resulting 95% confidence interval provides considerably more information than testing a specific null hypothesis: it gives us a range of plausible effect sizes which can be used to estimate potential effect sizes in larger clinical trials.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $450,175 )
2026	2026	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	1	5/14/2026	NEW	$450,175
														Subtotal = $450,175

Grand Total All Awards = $450,175

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Induction and Maintenance on Buprenorphine in Opioid Use Disorder: Investigation of a peripheral nerve block for autonomic dysfunction

Award Number: R21DA066044

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2028

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