A Study of SPG Block for Opioid Withdrawal

NCT04946656 | Completed

• 1 other identifier: 7930
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• enrollment: percent screened subjects who enroll

  We will measure the percent of screened participants who agree to enroll as part of the feasibility study

  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

  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)

  4 weeks

Study Arms (1)

SPG block

EXPERIMENTAL

The sphenopalatine ganglion will be blocked with bipuvacaine for this study

Procedure: sphenopalatine ganglion block

Interventions

sphenopalatine ganglion block PROCEDURE

The sphenopalatine ganglion will be blocked with bupivacaine for this study

SPG block

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Opioid Use Disorder, moderate to severe
• Ages 22 to 50
• Lives in New York City, able to travel for visits
• Willing to be admitted to an inpatient unit

You may not qualify if:

• Medical disorder, for who study participation could be deleterious (neurologic, cardiac, renal or infectious disease
• Hypertension: BP \> 150/100
• Elevated liver function tests (AST, ALT) \> 3x normal
• Having a painful medical illness for which opioids are needed (including upcoming surgery).

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry at Columbia University Irving Medical

Model Details: open label single group

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: July 1, 2021
• Study Start: February 3, 2023
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)