A Study of SPG Block for Opioid Withdrawal

Status Suspended

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04946656
Study type	Interventional
Source	New York State Psychiatric Institute
Contact
Status	Suspended
Phase	N/A
Start date	February 3, 2023
Completion date	June 3, 2030

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06021431` - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT	N/A
Completed	`NCT06266572` - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment	Phase 1
Recruiting	`NCT05037682` - Pain and Opioid Management in Older Adults	N/A
Completed	`NCT06200740` - Remotely Observed Methadone Evaluation	N/A
Not yet recruiting	`NCT06441604` - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy	Phase 2
Recruiting	`NCT06028126` - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial	N/A
Completed	`NCT02559973` - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder	Phase 1
Completed	`NCT02593474` - Medication-Assisted Treatment for Youth With Substance Use Disorders	Phase 1
Completed	`NCT02440256` - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial	N/A
Completed	`NCT05587998` - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.	Phase 1
Terminated	`NCT04577144` - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Recruiting	`NCT06001437` - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting	`NCT05976646` - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion	Phase 1/Phase 2
Completed	`NCT05546229` - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting	`NCT06416020` - Integrating MOUD in African American Community Settings (Better Together)	N/A
Not yet recruiting	`NCT06104280` - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment	N/A
Recruiting	`NCT06206291` - Cannabidiol for Opioid Addiction	Phase 2
Completed	`NCT05552040` - START NOW in the Treatment of Opioid Addicted Individuals	N/A
Recruiting	`NCT05459922` - Adjunctive Bright Light Therapy for Opioid Use Disorder	N/A
Recruiting	`NCT05343169` - Community-based Education, Navigation, and Support Intervention for Military Veterans	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.