Withdrawal SymptomsPhase 3VNS in OUD UH3NCT05834478
Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3
A Phase 3 study testing Transcutaneous Cervical Vagal Nerve Stimulation and [F-18]Fallypride in people with Withdrawal Symptoms and Opioid Use Disorder, run by Emory University at 6 sites in United States.
Trial summary
This study is being done to answer the question: what is the effect of Vagal Nerve Stimulation (VNS) dosing on opioid withdrawal responses in individuals with a history of Opioid Use Disorders (OUDs)? Eligible participants will be in the study for one week in an inpatient research hospital stay, have an MRI scan, and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Withdrawal Symptoms, Opioid Use Disorder, Opioid Use
- What is being tested?
- Transcutaneous Cervical Vagal Nerve Stimulation and [F-18]Fallypride
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Feb 2024to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet criteria for OUDs based on the DSM5 criteria
- Willing to undergo supervised withdrawal
- Willing to be transitioned to a MOUD or behavioral management during treatment aftercare
Who cannot join
- Positive pregnancy test or breastfeeding for women
- History of meningitis
- Traumatic brain injury
- Current treatment with methadone, naltrexone, or Suboxone or medications that would be contraindicated with hydromorphone or clonidine administration
- History of head trauma resulting in loss of consciousness (LOC) of greater than one minute where the LOC is not judged to be primarily related to overdose in the judgment of the study physician
- Past year moderate to severe non-opioid use disorders that would require separate withdrawal management
Show all 12Show fewer
- Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia
- History of serious medical or neurological illness or organic mental disorder, including liver disease, but also including cardiovascular, gastrointestinal, hepatic, renal, neurologic, or other systemic illness, including liver enzymes aspartate transaminase (AST) and alanine transaminase (ALT) more than three times upper limit of normal, that would preclude involvement based on the clinical judgment of the study psychiatrist
- Lack of venous access that would preclude PET imaging
- Active implantable device (i.e. pacemaker) or other VNS device exclusion
- History of shrapnel or other foreign bodies that would preclude MRI scanning
- Positive test for COVID-19
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University Clinical Research Network
Atlanta, Georgia, 30322
- Not yet recruiting
Health Sciences Research Building
Atlanta, Georgia, 30322
- Recruiting
Rollins School of Public Health
Atlanta, Georgia, 30322
- Recruiting
12 Executive Park Drive
Atlanta, Georgia, 30329
- Recruiting
Emory University
Atlanta, Georgia, 30329
- Recruiting
Georgia Institute of Technology
Atlanta, Georgia, 30332
About this study
This study is being done to answer the question: what is the effect of Vagal Nerve Stimulation (VNS) dosing on opioid withdrawal responses in individuals with a history of Opioid Use Disorders (OUDs)? Eligible participants will be in the study for one week in an inpatient research hospital stay, have an MRI scan, and have a follow-up call 1-3 months after their inpatient stay. Participants will complete several psychiatric questionnaires/interviews, physiological monitoring with several devices, brain imaging, and VNS testing.
Read the detailed description
The purpose of this study is to look at Opioid Use Disorders (OUDs) and Vagal Nerve Stimulation (VNS). OUDs are conditions involving misuse or addiction to opiate-containing prescription pain medications or opioid-containing substances including heroin. OUDs are associated with symptoms of withdrawal upon discontinuation of the substance, which can include problems with concentration and sleep, irritability, rapid heart rate, and craving for opioids. Vagal Nerve Stimulation (VNS) is a procedure where the vagus nerve, which is in the neck, is electrically stimulated, much like a pacemaker is used to stimulate the heart. Branches of the vagus nerve travel throughout the brain and the body. Vagal nerve stimulation is felt to have positive effects on the brain and body by blocking the sympathetic (adrenaline) response that occurs with withdrawal from opioids, as well as changes in the brain that drive a craving for opioids. A surgically implantable VNS has been approved by the Food and Drug Administration (FDA) for the treatment of both epilepsy and severe depression. Studies have shown that VNS stimulation is helpful for both conditions. Researchers are using a non-invasive hand-held VNS device made by a company called ElectroCore. It is applied directly to the neck and does not require surgery. It is approved in Europe for the treatment of epilepsy, anxiety, depression, headaches, and other conditions, and in the US by the FDA for the treatment of headaches. Investigators have studied its use at Emory for PTSD and have found it to be well tolerated and there have been no adverse events or untoward effects with the device. The research team conducted two initial studies in patients with OUDs and found that it was safe and that it reduced opioid craving and withdrawal as well as blocking the sympathetic (adrenaline) response to withdrawal. It has not yet been approved in the US by the FDA for the treatment of OUDs and is considered investigational in this study.
This study will enroll individuals that have been diagnosed with Opioid Use Disorder (OUD). The main purpose of this study is to look at the effects of VNS on behavior as well as the body and brain's responses to craving in patients with OUDs. Study procedures include a screening, mental health assessment, medical assessment, lab work, brain imaging (MRI and PET), and a follow-up call. It is possible that participants may not have brain imaging (MRI and PET) during the study. The study will be completed in around a week depending on the scheduling of the MRI visit. This might be completed during the inpatient stay or could be a separate visit. The research team will also plan to call and follow up with participants 1-3 months after the inpatient stay.
- Conditions
- Withdrawal Symptoms, Opioid Use Disorder, Opioid Use
- Being tested
- Transcutaneous Cervical Vagal Nerve Stimulation, Sham Stimulation, [F-18]Fallypride
- Keywords
- Non-invasive Vagal Nerve Stimulation, Vagus nerve, vagus nerve stimulation, OUD
- Medical subject headings
- Substance Withdrawal Syndrome, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Cervical Vagal Nerve StimulationDevice
Also called tcVNS
Participants will receive stimulation of the vagus nerve with the non-invasive transcutaneous cervical Vagal Nerve Stimulation (tcVNS), which does not require surgery or implantation, and electrically stimulates the vagus nerve as it passes through the neck, dampening the sympathetic nervous system and modulating brain regions to a single side of the neck with the GammaCore device. Participants will be trained on self-stimulation and from days 1-7 patients undergo four times daily self-stimulation with tcVNS first for two minutes on one side, followed by a one-minute pause, then two minutes on the same side. The intensity of the stimulus (i.e. the current amplitude) will be adjusted by the user, to the maximum tolerable level without causing excessive pain [typically 10-30 V and 60milliamperes (mA) (peak)], with an alternating current (AC) signal consisting of five 5 kilohertz (kHz) pulses 200 microseconds in duration, repeating at a rate of 25 Hz (about once every 40 milliseconds).
Sham StimulationDevice
Also called Sham stimulation of vagus nerve
Participants will have the same procedures as with the tcVNS but will instead receive a device that appears identical to the active tcVNS device in look, weight, visual and audible feedback, and also in user controls. The Sham device looks and sounds like an active device but does not deliver an electric current.
[F-18]FallyprideDrug
Also called Radiolabeled material
[F-18]Fallypride is a radioactive material. Each patient will have two [F-18]Fallypride PET scans. For each scan [F-18]Fallypride will be injected as an intravenous bolus. The radiation dose to body organs in this study is well within the Food and Drug Administration (FDA) national guidelines for radiation exposure for human research studies and less than the total amount that is permitted for research studies in one year.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Cervical Vagal Nerve Stimulation Device | Experimental | Stimulation with the tcVNS Receives: Device: Transcutaneous Cervical Vagal Nerve Stimulation; Drug: [F-18]Fallypride |
| Sham Stimulation Device | Sham comparator | Stimulation with the sham device. Receives: Device: Sham Stimulation; Drug: [F-18]Fallypride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Subjective Opiate Withdrawal Scale (SOWS) Score
All participants will complete the Subjective Opiate Withdrawal Scale (SOWS). The total score on each day will be compared between active tcVNS versus sham stimulation. The SOWS is performed four times daily. The total SOWS score is the sum of the individual item scores and ranges from 0 to 64, with a higher score indicating greater withdrawal severity.
Measured: Day 2, Day 3
Safety of tcVNS use
Defined as the absence of device related adverse events.
Measured: Up to 7 days after study initiation
Secondary outcomes (12)
Study retention
Study retention as defined by taking a single dose of Medication for Opioid Use Disorders (MOUD) (Suboxone, methadone, or naltrexone) within ten days of study initiation.
Measured: Baseline, Up to 10 days after study initiation
Treatment adherence
Defined by adherence to Medication for Opioid Use Disorders (MOUD)
Measured: 3 months
Change in brain dopamine D1 and D2/3 receptor regional binding potentials
Brain dopamine D1 and D2/3 receptor regional binding potentials will be measured with the brain imaging of the dopamine system with [F-18]fallypride with high-resolution positron emission tomography (HR-PET). Brain imaging of the dopamine system with [F-18]fallypride occurs at rest on day 2 and with active tcVNS or sham stimulation on day 3 while watching videos paired with tcVNS or sham stimulation.
Measured: Day 2, Day 3
Change in heart rate
Participants will be outfitted with ambulatory monitors to measure multiple peripheral physiological signals representative of cardiac electrophysiology.
Measured: Baseline, Day 2, Day 3
Change in inflammatory biomarkers
Interleukin 6 (IL-6) will be measured by having participants undergo blood sampling before and during exposure to neutral and pleasant videos paired with tcVNS or sham stimulation at specified study time points.
Measured: 15 minutes before stress and up to 180 minutes post-stress
Change in catecholamines concentration
Catecholamines concentration will be measured by drawing blood sampling during exposure to neutral and pleasant videos paired with tcVNS or sham stimulation at specified study time points.
Measured: Baseline, Day 2, Day 3
Squares analysis of SOWS score
Measured on each of day two and three based on the peak Subjective Opiate Withdrawal Scale (SOWS) Total score on each day compared between active tcVNS versus sham stimulation. The SOWS is performed four times daily.
Measured: Day 1, Day 7
Time to Rescue Medication
Patients receiving rescue medication with clonidine will have last observation carried forward.
Measured: Up to 7 days after study initiation
Change in Peak Clinical Opiate Withdrawal Scale (COWS) Scores
All participants will complete the Clinical Opiate Withdrawal Scale (COWS). This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids.
Measured: Day 2, Day 3
Transition to MOUD Treatment or Behavioral Management
The research team will monitor the time for participants to require MOUD and/or behavioral management.
Measured: Up to 7 days after study initiation
Change in Brain-derived Neurotrophic Factor (BDNF)
Participants will undergo blood sampling to measure BDNF during exposure to neutral and pleasant videos paired with tcVNS or sham stimulation at specified study time points.
Measured: 5 minutes before stress and up to 180 minutes post-stress
Change in Calcium-binding Protein B (S100B)
Participants will undergo blood sampling to measure S100B during exposure to neutral and pleasant videos paired with tcVNS or sham stimulation at specified study time points.
Measured: 5 minutes before stress and up to 180 minutes post-stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start20 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Withdrawal SymptomsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, James Douglas Bremner, Emory University
- Investigators
- James D Bremner, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834478
- Sponsor's protocol ID
- STUDY00005360
- Other IDs
- 4UH3DA048502, 2025P012727
- Acronym
- VNS in OUD UH3
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: At the conclusion of the trial, the data will be stripped of identifiers prior to release for sharing and will be made available in de-identified form to other investigators and other sites.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3
- ClinicalTrials.gov ID
- NCT05834478
- Acronym / sponsor ID
- VNS in OUD UH3 / STUDY00005360
- Conditions
- Withdrawal Symptoms, Opioid Use Disorder, Opioid Use
- Keywords
- Non-invasive Vagal Nerve Stimulation, Vagus nerve, vagus nerve stimulation, OUD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Apr 2023 (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.
This study is being done to answer the question: what is the effect of Vagal Nerve Stimulation (VNS) dosing on opioid withdrawal responses in individuals with a history of Opioid Use Disorders (OUDs)? Eligible participants will be in the study for one week in an inpatient research hospital stay, have an MRI scan, and have a follow-up call 1-3 months after their inpatient stay. Participants will complete several psychiatric questionnaires/interviews, physiological monitoring with several devices, brain imaging, and VNS testing.
Detailed description
The purpose of this study is to look at Opioid Use Disorders (OUDs) and Vagal Nerve Stimulation (VNS). OUDs are conditions involving misuse or addiction to opiate-containing prescription pain medications or opioid-containing substances including heroin. OUDs are associated with symptoms of withdrawal upon discontinuation of the substance, which can include problems with concentration and sleep, irritability, rapid heart rate, and craving for opioids. Vagal Nerve Stimulation (VNS) is a procedure where the vagus nerve, which is in the neck, is electrically stimulated, much like a pacemaker is used to stimulate the heart. Branches of the vagus nerve travel throughout the brain and the body. Vagal nerve stimulation is felt to have positive effects on the brain and body by blocking the sympathetic (adrenaline) response that occurs with withdrawal from opioids, as well as changes in the brain that drive a craving for opioids. A surgically implantable VNS has been approved by the Food and Drug Administration (FDA) for the treatment of both epilepsy and severe depression. Studies have shown that VNS stimulation is helpful for both conditions. Researchers are using a non-invasive hand-held VNS device made by a company called ElectroCore. It is applied directly to the neck and does not require surgery. It is approved in Europe for the treatment of epilepsy, anxiety, depression, headaches, and other conditions, and in the US by the FDA for the treatment of headaches. Investigators have studied its use at Emory for PTSD and have found it to be well tolerated and there have been no adverse events or untoward effects with the device. The research team conducted two initial studies in patients with OUDs and found that it was safe and that it reduced opioid craving and withdrawal as well as blocking the sympathetic (adrenaline) response to withdrawal. It has not yet been approved in the US by the FDA for the treatment of OUDs and is considered investigational in this study.
This study will enroll individuals that have been diagnosed with Opioid Use Disorder (OUD). The main purpose of this study is to look at the effects of VNS on behavior as well as the body and brain's responses to craving in patients with OUDs. Study procedures include a screening, mental health assessment, medical assessment, lab work, brain imaging (MRI and PET), and a follow-up call. It is possible that participants may not have brain imaging (MRI and PET) during the study. The study will be completed in around a week depending on the scheduling of the MRI visit. This might be completed during the inpatient stay or could be a separate visit. The research team will also plan to call and follow up with participants 1-3 months after the inpatient stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Cervical Vagal Nerve Stimulation Device | Experimental | Device: Transcutaneous Cervical Vagal Nerve Stimulation, Drug: [F-18]FallyprideStimulation with the tcVNS |
| Sham Stimulation Device | Sham comparator | Device: Sham Stimulation, Drug: [F-18]FallyprideStimulation with the sham device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet criteria for OUDs based on the DSM5 criteria
- Willing to undergo supervised withdrawal
- Willing to be transitioned to a MOUD or behavioral management during treatment aftercare
Key exclusion criteria (12 listed)
- Positive pregnancy test or breastfeeding for women
- History of meningitis
- Traumatic brain injury
- Current treatment with methadone, naltrexone, or Suboxone or medications that would be contraindicated with hydromorphone or clonidine administration
- History of head trauma resulting in loss of consciousness (LOC) of greater than one minute where the LOC is not judged to be primarily related to overdose in the judgment of the study physician
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 |
|---|---|---|
| Transcutaneous Cervical Vagal Nerve StimulationAlso: tcVNSParticipants will receive stimulation of the vagus nerve with the non-invasive transcutaneous cervical Vagal Nerve Stimulation (tcVNS), which does not require surgery or implantation, and electrically stimulates the vagus nerve as it passes through the neck, dampening the sympathetic nervous system and modulating brain regions to a single side of the neck with the GammaCore device. Participants will be trained on self-stimulation and from days 1-7 patients undergo four times daily self-stimulation with tcVNS first for two minutes on one side, followed by a one-minute pause, then two minutes on the same side. The intensity of the stimulus (i.e. the current amplitude) will be adjusted by the user, to the maximum tolerable level without causing excessive pain [typically 10-30 V and 60milliamperes (mA) (peak)], with an alternating current (AC) signal consisting of five 5 kilohertz (kHz) pulses 200 microseconds in duration, repeating at a rate of 25 Hz (about once every 40 milliseconds). | Device | Transcutaneous Cervical Vagal Nerve Stimulation Device |
| Sham StimulationAlso: Sham stimulation of vagus nerveParticipants will have the same procedures as with the tcVNS but will instead receive a device that appears identical to the active tcVNS device in look, weight, visual and audible feedback, and also in user controls. The Sham device looks and sounds like an active device but does not deliver an electric current. | Device | Sham Stimulation Device |
| [F-18]FallyprideAlso: Radiolabeled material[F-18]Fallypride is a radioactive material. Each patient will have two [F-18]Fallypride PET scans. For each scan [F-18]Fallypride will be injected as an intravenous bolus. The radiation dose to body organs in this study is well within the Food and Drug Administration (FDA) national guidelines for radiation exposure for human research studies and less than the total amount that is permitted for research studies in one year. | Drug | Sham Stimulation Device, Transcutaneous Cervical Vagal Nerve Stimulation Device |
Primary outcome
Change in Peak Subjective Opiate Withdrawal Scale (SOWS) Score
Time frame: Day 2, Day 3
All participants will complete the Subjective Opiate Withdrawal Scale (SOWS). The total score on each day will be compared between active tcVNS versus sham stimulation. The SOWS is performed four times daily. The total SOWS score is the sum of the individual item scores and ranges from 0 to 64, with a higher score indicating greater withdrawal severity.
Safety of tcVNS use
Time frame: Up to 7 days after study initiation
Defined as the absence of device related adverse events.
12 secondary outcomes
Study retention
Time frame: Baseline, Up to 10 days after study initiation
Treatment adherence
Time frame: 3 months
Change in brain dopamine D1 and D2/3 receptor regional binding potentials
Time frame: Day 2, Day 3
Change in heart rate
Time frame: Baseline, Day 2, Day 3
Change in inflammatory biomarkers
Time frame: 15 minutes before stress and up to 180 minutes post-stress
Change in catecholamines concentration
Time frame: Baseline, Day 2, Day 3
Squares analysis of SOWS score
Time frame: Day 1, Day 7
Time to Rescue Medication
Time frame: Up to 7 days after study initiation
Change in Peak Clinical Opiate Withdrawal Scale (COWS) Scores
Time frame: Day 2, Day 3
Transition to MOUD Treatment or Behavioral Management
Time frame: Up to 7 days after study initiation
Change in Brain-derived Neurotrophic Factor (BDNF)
Time frame: 5 minutes before stress and up to 180 minutes post-stress
Change in Calcium-binding Protein B (S100B)
Time frame: 5 minutes before stress and up to 180 minutes post-stress
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. At the conclusion of the trial, the data will be stripped of identifiers prior to release for sharing and will be made available in de-identified form to other investigators and other sites.
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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.
James D Bremner, MD principal investigator
Emory University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcutaneous Cervical Vagal Nerve Stimulation and [F-18]Fallypride in people with Withdrawal Symptoms and Opioid Use Disorder, run by Emory University at 6 sites 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James D Bremner, MD (404-712-9569, jdbremn@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Subjective Opiate Withdrawal Scale (SOWS) Score (time frame: Day 2, Day 3). The study lists 2 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 27 Mar 2026.