Opioid WithdrawalNCT05555485
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
A study testing transcutaneous Auricular neurostimulation - Active in people with Opioid Withdrawal and Analgesia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Withdrawal, Analgesia
- What is being tested?
- transcutaneous Auricular neurostimulation - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 30 Sep 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 65 years of age
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
- Presence of pain on more than half of the days in the last six months
- Must have proof of prescribed medication by either showing a prescription bottle with the individual's name or the presence of a prescription on the Prescription Drug Monitoring Program (PDMP)
- Willingness to taper opioid dose by at least 10%
- Patient or provider requests opioid dose reduction or discontinuation.
Show all 9Show fewer
- Urine Drug Screen (UDS) must be positive for their prescribed opioid
- Urine Drug Test must be negative for illicit drugs, benzodiazepines, and nonprescribed opioids
- Must agree to use nicotine patches and/or gum instead of smoking or vaping in the UTMB facilities
Who cannot join
- Currently receiving treatment for cancer
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participant has abnormal ear anatomy or current ear infection present
- Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
- Currently receiving a prescription benzodiazepine medication
Show all 14Show fewer
- Current prescription opioid dose >50 MME/day
- Current abuse of illicit drugs or alcohol (nicotine use is acceptable).
- Surgery within the previous month
- Report of suicide attempt or psychiatric hospitalization in the past 10 years.
- Current suicidal ideation with specific plan or intent
- Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
- Females who are pregnant or lactating
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Denise Wilkes, MD-PhD, 409-772-1221, dwilkes@utmb.edu
David Houghton, PhD, 281-797-2130, dahought@utmb.edu
About this study
Official title: Understanding the Mechanistic, Neurophysiological, and Antinociceptive Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The investigator will also investigate changes in the way each participant perceive sensations of pressure and heat. The participant will be asked to reduce the amount of pain medication that they take. Then, the participant will spend several days and nights in the Clinical Research Center at UTMB (University of Texas Medical Branch) in Galveston. During that time, the participant will be monitored for withdrawal symptoms and will receive either active (e.g., "real") brain stimulation or sham (e.g., "fake") brain stimulation for two days (four hours each day). At two times over the course of the study (before and after ear stimulation treatment), the participant will complete questionnaires about their pain score and how they are feeling, sensory testing, and will undergo magnetic resonance imaging (MRI) of their brain. The investigator will collect the following information from the participant's medical record: age, gender, medication history, medical diagnoses, recent vital signs, past doctor visits or hospital stays, and results of urine drug tests. Participation in this study will last approximately four days, and the participant will stay in the Clinical Research Center.
Read the detailed description
Rationale and Aims
The current project will build on the previous tAN (transcutaneous auricular neurostimulation) research and clinical studies on chronic pain and opioid withdrawal, ultimately providing a "neural blueprint" of how tAN therapy can mitigate pain and opioid withdrawal symptoms. The investigators will conduct a clinical mechanistic trial of tAN in chronic pain patients tapering from therapeutic opioids. The study will accomplish the following Aim and address the following hypotheses:
Aim: Establish the functional MRI (fMRI) neurophysiological signature specifically underlying tAN-based analgesia in chronic pain participants undergoing an opioid taper.
Hypothesis 1: Chronic pain participants who receive tAN stimulation will demonstrate increased fMRI signal activation in vagal afferents within the brainstem compared to sham treatment.
Hypothesis 2: Chronic pain participants who receive tAN will demonstrate decreased fMRI signal activation in the cortical and subcortical pain network compared to sham treatment.
Exploratory Hypothesis 1: tAN-based changes in brain activation will correlate with measures of pain, and the severity of depression and anxiety to specifically delineate the overlay and distinguishing factors between the brain signatures of analgesia, and discomfort.
Study Summary On Day 1 at the CRC (Clinical Research Center), the investigators will review the consent and obtain consent. the investigators will reduce the amount of pain medication on the first day and continue for four days. The reduction in dose will be 10-20% of the participants daily pain medication dose. The participant will complete questionnaires, submit a UDS, MRI, and sensory testing. On Day 2, the participant will be randomly assigned to receive either active, (real) brain stimulation or sham (fake) brain stimulation. The participant have an equal chance of being assigned to either group (similar to flipping a coin). Sham brain stimulation will look and feel like active stimulation. The participant will not be able to tell which type of stimulation is received until the participant complete the study. Brain stimulation will be delivered on the second and third days of the study for approximately four hours each day (e.g., four sessions of stimulation for one hour each day). On Day 3, the participant will receive four hours of stimulation. On Days 2 and 3, the participant will have your heart rate, blood pressure, and breathing rate measured; and will complete withdrawal symptom questionnaires and will give a pain score every four hours from 8am to 8pm. The researchers will not disturb participants at night. On Day 4, the participant will complete questionnaires, MRI, and sensory testing. The stimulation device will be returned to study personnel at the end of the study. The participant's pain physician can contact Spark Biomedical and prescribe the stimulation device for continued use at home.
- Conditions
- Opioid Withdrawal, Analgesia
- Being tested
- transcutaneous Auricular neurostimulation - Active, transcutaneous auricular neurostimulation - Sham
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous Auricular neurostimulation - ActiveDevice
Also called the Sparrow
Active auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved
transcutaneous auricular neurostimulation - ShamDevice
Sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX) but will not deliver prolonged stimulation.
| Study group | Role | What they receive |
|---|---|---|
| tAN stimulation - sham | Sham comparator | Active or sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved. Receives: Device: transcutaneous auricular neurostimulation - Sham |
| tAN stimulation - active | Active comparator | Active or sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved Receives: Device: transcutaneous Auricular neurostimulation - Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical opioid withdrawal scale (COWS)
Examination and scoring of symptoms of opioid withdrawal. score range is 1-36 with 1-2 mild, 3-24 moderate, and 25-36 severe withdrawal symptoms measured pre-treatment (day 1) and post-treatment (day4
Measured: day 1 and day 4
Secondary outcomes (4)
Pain, enjoyment, and general activity (PEG3)
changes from pre to post questionnaires. The scale is 0-30 with the lowest score is the best and higher scores are worse.
Measured: day 1 and day 4
Patient Health Questionnaire (PHQ9)
This measures depression. The scale is 0-20 with less than 4 does not need treatment, 5-13 clinical judgement decides treatment, and greater than 14 needs treatment
Measured: day 1 and day 4
Patient reported outcome measurement anxiety (PROMIS-A): questionnaire
This questionnaire measures anxiety with a scale of 36-82. A t-score of 55-59.9 is mild, 60-69.9 is moderate, and greater than 70 is severe
Measured: day 1 and day4
Patient reported outcome measurement depression (PROMIS-D): questionnaire
This questionnaire measures depression with a scale of 8-40. The higher the score the more severe is the depression.
Measured: day 1 and day4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start24 May 2023
- Primary completion21 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid WithdrawalStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will be randomized to one of two arms (active tAN vs. sham tAN) in a 1:1 fashion such that each arm will have 20 participants with complete data. A block randomization procedure will be utilized to ensure that equal numbers of participants are assigned to each of the two conditions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Medical University of South Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555485
- Sponsor's protocol ID
- 22-0187
- Other IDs
- 1RM1NS128787-01
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pierson CJ, Khodaparast N, McWade MA, Kuo YF, Houghton DC, Rodriguez SL, Korschgen VL, Cunningham KA, Wilkes DM. The protocol for a randomized, sham-controlled trial of transcutaneous auricular neurostimulation for chronic pain and opioid withdrawal symptoms during a 4-day opioid taper for adults in the United States. Trials. 2025 Oct 16;26(1):421. doi: 10.1186/s13063-025-09171-4.
PubMed 41102821
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Mechanistic, Neurophysiological, and Antinociceptive Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT05555485
- Acronym / sponsor ID
- 22-0187
- Conditions
- Opioid Withdrawal, Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Medical University of South Carolina
- Study start
- 24 May 2023 (actual)
- Primary completion
- 21 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Sep 2022 (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.
The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The investigator will also investigate changes in the way each participant perceive sensations of pressure and heat. The participant will be asked to reduce the amount of pain medication that they take. Then, the participant will spend several days and nights in the Clinical Research Center at UTMB (University of Texas Medical Branch) in Galveston. During that time, the participant will be monitored for withdrawal symptoms and will receive either active (e.g., "real") brain stimulation or sham (e.g., "fake") brain stimulation for two days (four hours each day). At two times over the course of the study (before and after ear stimulation treatment), the participant will complete questionnaires about their pain score and how they are feeling, sensory testing, and will undergo magnetic resonance imaging (MRI) of their brain. The investigator will collect the following information from the participant's medical record: age, gender, medication history, medical diagnoses, recent vital signs, past doctor visits or hospital stays, and results of urine drug tests. Participation in this study will last approximately four days, and the participant will stay in the Clinical Research Center.
Detailed description
Rationale and Aims
The current project will build on the previous tAN (transcutaneous auricular neurostimulation) research and clinical studies on chronic pain and opioid withdrawal, ultimately providing a "neural blueprint" of how tAN therapy can mitigate pain and opioid withdrawal symptoms. The investigators will conduct a clinical mechanistic trial of tAN in chronic pain patients tapering from therapeutic opioids. The study will accomplish the following Aim and address the following hypotheses:
Aim: Establish the functional MRI (fMRI) neurophysiological signature specifically underlying tAN-based analgesia in chronic pain participants undergoing an opioid taper.
Hypothesis 1: Chronic pain participants who receive tAN stimulation will demonstrate increased fMRI signal activation in vagal afferents within the brainstem compared to sham treatment.
Hypothesis 2: Chronic pain participants who receive tAN will demonstrate decreased fMRI signal activation in the cortical and subcortical pain network compared to sham treatment.
Exploratory Hypothesis 1: tAN-based changes in brain activation will correlate with measures of pain, and the severity of depression and anxiety to specifically delineate the overlay and distinguishing factors between the brain signatures of analgesia, and discomfort.
Study Summary On Day 1 at the CRC (Clinical Research Center), the investigators will review the consent and obtain consent. the investigators will reduce the amount of pain medication on the first day and continue for four days. The reduction in dose will be 10-20% of the participants daily pain medication dose. The participant will complete questionnaires, submit a UDS, MRI, and sensory testing. On Day 2, the participant will be randomly assigned to receive either active, (real) brain stimulation or sham (fake) brain stimulation. The participant have an equal chance of being assigned to either group (similar to flipping a coin). Sham brain stimulation will look and feel like active stimulation. The participant will not be able to tell which type of stimulation is received until the participant complete the study. Brain stimulation will be delivered on the second and third days of the study for approximately four hours each day (e.g., four sessions of stimulation for one hour each day). On Day 3, the participant will receive four hours of stimulation. On Days 2 and 3, the participant will have your heart rate, blood pressure, and breathing rate measured; and will complete withdrawal symptom questionnaires and will give a pain score every four hours from 8am to 8pm. The researchers will not disturb participants at night. On Day 4, the participant will complete questionnaires, MRI, and sensory testing. The stimulation device will be returned to study personnel at the end of the study. The participant's pain physician can contact Spark Biomedical and prescribe the stimulation device for continued use at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will be randomized to one of two arms (active tAN vs. sham tAN) in a 1:1 fashion such that each arm will have 20 participants with complete data. A block randomization procedure will be utilized to ensure that equal numbers of participants are assigned to each of the two conditions.
| Arm | Type | Receives |
|---|---|---|
| tAN stimulation - sham | Sham comparator | Device: transcutaneous auricular neurostimulation - ShamActive or sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved. |
| tAN stimulation - active | Active comparator | Device: transcutaneous Auricular neurostimulation - ActiveActive or sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females between 18 and 65 years of age
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
- Presence of pain on more than half of the days in the last six months
- Must have proof of prescribed medication by either showing a prescription bottle with the individual's name or the presence of a prescription on the Prescription Drug Monitoring Program (PDMP)
- Willingness to taper opioid dose by at least 10%
Key exclusion criteria (14 listed)
- Currently receiving treatment for cancer
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participant has abnormal ear anatomy or current ear infection present
- Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
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 Auricular neurostimulation - ActiveAlso: the SparrowActive auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved | Device | tAN stimulation - active |
| transcutaneous auricular neurostimulation - ShamSham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX) but will not deliver prolonged stimulation. | Device | tAN stimulation - sham |
Primary outcome
Clinical opioid withdrawal scale (COWS)
Time frame: day 1 and day 4
Examination and scoring of symptoms of opioid withdrawal. score range is 1-36 with 1-2 mild, 3-24 moderate, and 25-36 severe withdrawal symptoms measured pre-treatment (day 1) and post-treatment (day4
4 secondary outcomes
Pain, enjoyment, and general activity (PEG3)
Time frame: day 1 and day 4
Patient Health Questionnaire (PHQ9)
Time frame: day 1 and day 4
Patient reported outcome measurement anxiety (PROMIS-A): questionnaire
Time frame: day 1 and day4
Patient reported outcome measurement depression (PROMIS-D): questionnaire
Time frame: day 1 and day4
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 10 Aug 2026.
- Derived from this study: PubMed 41102821Pierson CJ, Khodaparast N, McWade MA, Kuo YF, Houghton DC, Rodriguez SL, Korschgen VL, Cunningham KA, Wilkes DM. The protocol for a randomized, sham-controlled trial of transcutaneous auricular neurostimulation for chronic pain and opioid withdrawal symptoms during a 4-day opioid taper for adults in the United States. Trials. 2025 Oct 16;26(1):421. doi: 10.1186/s13063-025-09171-4.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous Auricular neurostimulation - Active in people with Opioid Withdrawal and Analgesia, run by The University of Texas Medical Branch, Galveston 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 9 inclusion and 14 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 10 Aug 2026. 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. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical opioid withdrawal scale (COWS) (time frame: day 1 and day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555485, which also lists 1 linked publication.
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 10 Aug 2026.