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临床试验/NCT04946656
NCT04946656已完成不适用

A Study of SPG Block for Opioid Withdrawal

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
1
主要终点
retention: percent enrolled subjects who complete

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
22 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

结局指标

主要结局

retention: percent enrolled subjects who complete

时间窗: 4 weeks

We will measure the percent of enrolled participants who complete the study as part of the feasibility study

tolerability: percent adverse events, if any

时间窗: 4 weeks

We will measure the percent of adverse events in this feasibility study, if any measured with the CTCAE grading system (rate 0 to 5)

enrollment: percent screened subjects who enroll

时间窗: 4 weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Martinez

Professor of Psychiatry at Columbia University Irving Medical

New York State Psychiatric Institute

研究点 (1)

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