Opioid Use DisorderNCT04946656
A Study of SPG Block for Opioid Withdrawal
A study testing sphenopalatine ganglion block in people with Opioid Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- sphenopalatine ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Opioid Use Disorder
- Being tested
- sphenopalatine ganglion block
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sphenopalatine ganglion blockProcedure or surgery
The sphenopalatine ganglion will be blocked with bupivacaine for this study
| Study group | Role | What they receive |
|---|---|---|
| SPG block | Experimental | The sphenopalatine ganglion will be blocked with bipuvacaine for this study Receives: Procedure: sphenopalatine ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
enrollment: percent screened subjects who enroll
We will measure the percent of screened participants who agree to enroll as part of the feasibility study
Measured: 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
Measured: 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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start3 Feb 2023
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Martinez, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946656
- Sponsor's protocol ID
- 7930
- Status last verified
- Oct 2025
- First submitted
- 20 May 2021
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of SPG Block for Opioid Withdrawal
- ClinicalTrials.gov ID
- NCT04946656
- Acronym / sponsor ID
- 7930
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label single group
| Arm | Type | Receives |
|---|---|---|
| SPG block | Experimental | Procedure: sphenopalatine ganglion blockThe sphenopalatine ganglion will be blocked with bipuvacaine for this study |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sphenopalatine ganglion blockThe sphenopalatine ganglion will be blocked with bupivacaine for this study | Procedure or surgery | SPG block |
Primary outcome
enrollment: percent screened subjects who enroll
Time frame: 4 weeks
We will measure the percent of screened participants who agree to enroll as part of the feasibility study
retention: percent enrolled subjects who complete
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sphenopalatine ganglion block in people with Opioid Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
enrollment: percent screened subjects who enroll (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.