Iatrogenic Withdrawal SyndromeNCT05025384
Jackson Pediatric Acupressure for Opioid Tapering
A study testing Acupressure in people with Iatrogenic Withdrawal Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt… Read more about this study
- Who is it for?
- Ages 34 weeks and older
- Conditions the study is for
- Iatrogenic Withdrawal Syndrome
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 21 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 34 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants, 34 weeks or greater gestation
- Exposure to opioids and/or benzodiazepine medications for 5 days or more
- Beginning a stable wean
- Maternal age of 18 or older
Who cannot join
- Hemodynamic instability
- Transfer to another facility prior to completion of the weaning regimen
- Death
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: Auricular Acupressure as an Adjunct Treatment for Opioid Tapering in a Pediatric Cardiac Intensive Care Unit: A Pilot Feasibility Study
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt (MCJCHV). The investigators will recruit 40 healthy, 34 weeks gestational age or older infants exposed to prolonged medications (greater than 5 days) for cardiac procedures that may cause withdrawal upon cessation such as opioids, benzodiazepines, or other sedative medications. Participants will receive the auricular acupressure in addition to the standard of care such as clustered nursing care, touch, position change, environmental controls, holding, and swaddling.
Read the detailed description
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt (MCJCHV). The investigators will recruit 40 healthy, 34 weeks gestational age or older infants exposed to prolonged medications (greater than 5 days) for cardiac procedures that may cause withdrawal upon cessation such as opioids, benzodiazepines, or other sedative medications. Participants will receive the auricular acupressure in addition to the standard of care such as clustered nursing care, touch, position change, environmental controls, holding, and swaddling. Within 24 hours of implementing a weaning protocol, acupressure will be applied to three designated points of one ear following the NADA protocol acupuncture technique while also incorporating the Near-Term Infant (NTI) conceptual framework identified elements (see figure 3). Acupressure will be administered via stickers that are adhesive to the skin like a Band-Aid (see figure 1). These stickers include a vaccaria plant seed in the center that applies continuous light pressure on the designated points. This form of acupressure was selected as it is organic and does not contain metal which may interfere with emergency medical care such as imaging. After the initial 24 hours of application, stickers will be removed, the infant's skin will be assessed for any disruption such as bruising or discoloration, and the stickers will be rotated to the infant's other ear at the same NADA protocol auricular sites. Acupressure stickers will be removed and applied to the opposite ear every 48 hours until withdrawal symptoms improve (1). Withdrawal symptoms are measured every 6 hours with the enhanced Withdrawal Assessment tool (WAT) as part of the standard of care. Upon completion of the weaning regimen, infants with a score of less than or equal to 3 or less than 2 above baseline with no more than 2 rescue medication doses in 24 hours will have the acupressure removed.
- Conditions
- Iatrogenic Withdrawal Syndrome
- Being tested
- Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Application will occur at designated points including Shen Men, Liver, and Lung: in the room with the mother; and potentially during breast feeding, holding, skin to skin contact or bottle feeds. Stickers will remain in place for 24 hours.
At 24 hours, skin will be assessed, and stickers will then be rotated to the opposite ear every 48 - 72 hours if there are no adverse effects such as skin irritation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Receives: Other: Acupressure |
| No Intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1)
The Withdrawal Assessment Tool- Version 1 (WAT-1) monitors opioid and benzodiazepine withdrawal symptoms in pediatric patients. A total of 19 withdrawal symptoms are rated where 0 indicates no symptoms and 10 is worst possible score in indicating intensity of withdrawal.
Measured: Baseline to 72 hours
Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
Prevalence of Delirium will be reported using the preschool confusion assessment method for the ICU (psCAM-ICU).
The psCAM-ICU is designed to assess for presence of delirium in critically ill children with or without mechanical ventilation. The psCAM-ICU was designed with cognitive testing that is developmentally appropriate for infants-5 years. Presence of Delirium is assessed using: 1) Acute change or fluctuating course of mental status, 2) Inattention, 3) Altered level of consciousness, 4) disorganized thinking. Presence of number 1) AND number 2) AND either number 3) OR number 4) indicates delirium is present. The following is how the data was coded: '1' for present and '2' for absent.
Measured: Baseline to 72 hours
Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS)
RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was median change in RASS score between baseline (immediately before randomized intervention or standard of care) and 72 hours later.
Measured: Baseline to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start25 Oct 2021
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants will be randomized in a 1:1 ratio to two groups - intervention vs. no intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Jackson, Vanderbilt University Medical Center
- Investigators
- Heather Jackson, MSN, APRN, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025384
- Sponsor's protocol ID
- 210213
- Status last verified
- Jan 2025
- First submitted
- 24 Aug 2021
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwartz L, Xiao R, Brown E, Sommers E. Auricular acupressure augmentation of standard medical management of the neonatal narcotic abstinence syndrome. Medical Acupuncture. 2011;23(3):175-86.
Amirnovin R, Sanchez-Pinto LN, Okuhara C, Lieu P, Koh JY, Rodgers JW, Nelson LP. Implementation of a Risk-Stratified Opioid and Benzodiazepine Weaning Protocol in a Pediatric Cardiac ICU. Pediatr Crit Care Med. 2018 Nov;19(11):1024-1032. doi: 10.1097/PCC.0000000000001719.
PubMed 30234674McPherson C, Inder T. Perinatal and neonatal use of sedation and analgesia. Semin Fetal Neonatal Med. 2017 Oct;22(5):314-320. doi: 10.1016/j.siny.2017.07.007. Epub 2017 Jul 19.
PubMed 28734732Weber F, Van Beek S, Scoones G. Potential neurotoxicity of anesthetic drugs in young children: who cares? A survey among European anesthetists. Minerva Anestesiol. 2016 Mar;82(3):294-300. Epub 2015 Sep 3.
PubMed 26337372Chen X, Wan Y, Wen K, Liang T, Lin T, Li P. [Perioperative anesthetic exposure and the neurodevelopmental status of 1 year old baby underwent neonatal cardiac surgery]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Nov;40(11):1234-8. doi: 10.11817/j.issn.1672-7347.2015.11.012. Chinese.
PubMed 26643428Mebius MJ, Kooi EMW, Bilardo CM, Bos AF. Brain Injury and Neurodevelopmental Outcome in Congenital Heart Disease: A Systematic Review. Pediatrics. 2017 Jul;140(1):e20164055. doi: 10.1542/peds.2016-4055. Epub 2017 Jun 13.
PubMed 28607205Barnett AM, Machovec KA, Ames WA, Homi HM, Turi JL, Koo J, Fuller M, Jooste EH. The effect of intraoperative methadone during pediatric cardiac surgery on postoperative opioid requirements. Paediatr Anaesth. 2020 Jul;30(7):773-779. doi: 10.1111/pan.13903. Epub 2020 Jun 25.
PubMed 32365412Gupta P, Whiteside W, Sabati A, Tesoro TM, Gossett JM, Tobias JD, Roth SJ. Safety and efficacy of prolonged dexmedetomidine use in critically ill children with heart disease*. Pediatr Crit Care Med. 2012 Nov;13(6):660-6. doi: 10.1097/PCC.0b013e318253c7f1.
PubMed 22791093Edwards L, Brown LF. Nonpharmacologic Management of Neonatal Abstinence Syndrome: An Integrative Review. Neonatal Netw. 2016;35(5):305-13. doi: 10.1891/0730-0832.35.5.305.
PubMed 27636695Maguire D. Care of the infant with neonatal abstinence syndrome: strength of the evidence. J Perinat Neonatal Nurs. 2014 Jul-Sep;28(3):204-11; quiz E3-4. doi: 10.1097/JPN.0000000000000042.
PubMed 25062522Stuyt EB, Voyles CA, Bursac S. NADA Protocol for Behavioral Health. Putting Tools in the Hands of Behavioral Health Providers: The Case for Auricular Detoxification Specialists. Medicines (Basel). 2018 Feb 7;5(1):20. doi: 10.3390/medicines5010020.
PubMed 29414848Association NAD. Acupuncture Detoxification Specialist Training and Resource Manual. Fourth ed: NADA Literature Clearinghouse; 2015. 203 p.
Bergdahl L, Berman AH, Haglund K. Patients' experience of auricular acupuncture during protracted withdrawal. J Psychiatr Ment Health Nurs. 2014 Mar;21(2):163-9. doi: 10.1111/jpm.12028. Epub 2012 Dec 12.
PubMed 23230968Landgren K, Kvorning N, Hallstrom I. Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study. Acupunct Med. 2010 Dec;28(4):174-9. doi: 10.1136/aim.2010.002394. Epub 2010 Oct 18.
PubMed 20959312Gentry KR, McGinn KL, Kundu A, Lynn AM. Acupuncture therapy for infants: a preliminary report on reasons for consultation, feasibility, and tolerability. Paediatr Anaesth. 2012 Jul;22(7):690-5. doi: 10.1111/j.1460-9592.2011.03743.x. Epub 2011 Dec 6.
PubMed 22141917
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupressure as an Adjunct Treatment for Opioid Tapering in a Pediatric Cardiac Intensive Care Unit: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05025384
- Acronym / sponsor ID
- 210213
- Conditions
- Iatrogenic Withdrawal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt (MCJCHV). The investigators will recruit 40 healthy, 34 weeks gestational age or older infants exposed to prolonged medications (greater than 5 days) for cardiac procedures that may cause withdrawal upon cessation such as opioids, benzodiazepines, or other sedative medications. Participants will receive the auricular acupressure in addition to the standard of care such as clustered nursing care, touch, position change, environmental controls, holding, and swaddling.
Detailed description
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt (MCJCHV). The investigators will recruit 40 healthy, 34 weeks gestational age or older infants exposed to prolonged medications (greater than 5 days) for cardiac procedures that may cause withdrawal upon cessation such as opioids, benzodiazepines, or other sedative medications. Participants will receive the auricular acupressure in addition to the standard of care such as clustered nursing care, touch, position change, environmental controls, holding, and swaddling. Within 24 hours of implementing a weaning protocol, acupressure will be applied to three designated points of one ear following the NADA protocol acupuncture technique while also incorporating the Near-Term Infant (NTI) conceptual framework identified elements (see figure 3). Acupressure will be administered via stickers that are adhesive to the skin like a Band-Aid (see figure 1). These stickers include a vaccaria plant seed in the center that applies continuous light pressure on the designated points. This form of acupressure was selected as it is organic and does not contain metal which may interfere with emergency medical care such as imaging. After the initial 24 hours of application, stickers will be removed, the infant's skin will be assessed for any disruption such as bruising or discoloration, and the stickers will be rotated to the infant's other ear at the same NADA protocol auricular sites. Acupressure stickers will be removed and applied to the opposite ear every 48 hours until withdrawal symptoms improve (1). Withdrawal symptoms are measured every 6 hours with the enhanced Withdrawal Assessment tool (WAT) as part of the standard of care. Upon completion of the weaning regimen, infants with a score of less than or equal to 3 or less than 2 above baseline with no more than 2 rescue medication doses in 24 hours will have the acupressure removed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants will be randomized in a 1:1 ratio to two groups - intervention vs. no intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AcupressureAcupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. |
| No Intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 34 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infants, 34 weeks or greater gestation
- Exposure to opioids and/or benzodiazepine medications for 5 days or more
- Beginning a stable wean
- Maternal age of 18 or older
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Transfer to another facility prior to completion of the weaning regimen
- Death
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 |
|---|---|---|
| AcupressureAcupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Application will occur at designated points including Shen Men, Liver, and Lung: in the room with the mother; and potentially during breast feeding, holding, skin to skin contact or bottle feeds. Stickers will remain in place for 24 hours. At 24 hours, skin will be assessed, and stickers will then be rotated to the opposite ear every 48 - 72 hours if there are no adverse effects such as skin irritation. | Other | Intervention |
Primary outcome
Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1)
Time frame: Baseline to 72 hours
The Withdrawal Assessment Tool- Version 1 (WAT-1) monitors opioid and benzodiazepine withdrawal symptoms in pediatric patients. A total of 19 withdrawal symptoms are rated where 0 indicates no symptoms and 10 is worst possible score in indicating intensity of withdrawal.
Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
Time frame: Baseline to 72 hours
Prevalence of Delirium will be reported using the preschool confusion assessment method for the ICU (psCAM-ICU). The psCAM-ICU is designed to assess for presence of delirium in critically ill children with or without mechanical ventilation. The psCAM-ICU was designed with cognitive testing that is developmentally appropriate for infants-5 years. Presence of Delirium is assessed using: 1) Acute change or fluctuating course of mental status, 2) Inattention, 3) Altered level of consciousness, 4) disorganized thinking. Presence of number 1) AND number 2) AND either number 3) OR number 4) indicates delirium is present. The following is how the data was coded: '1' for present and '2' for absent.
Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS)
Time frame: Baseline to 72 hours
RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was median change in RASS score between baseline (immediately before randomized intervention or standard of care) and 72 hours later.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSchwartz L, Xiao R, Brown E, Sommers E. Auricular acupressure augmentation of standard medical management of the neonatal narcotic abstinence syndrome. Medical Acupuncture. 2011;23(3):175-86.
- Background: PubMed 30234674Amirnovin R, Sanchez-Pinto LN, Okuhara C, Lieu P, Koh JY, Rodgers JW, Nelson LP. Implementation of a Risk-Stratified Opioid and Benzodiazepine Weaning Protocol in a Pediatric Cardiac ICU. Pediatr Crit Care Med. 2018 Nov;19(11):1024-1032. doi: 10.1097/PCC.0000000000001719.
- Background: PubMed 28734732McPherson C, Inder T. Perinatal and neonatal use of sedation and analgesia. Semin Fetal Neonatal Med. 2017 Oct;22(5):314-320. doi: 10.1016/j.siny.2017.07.007. Epub 2017 Jul 19.
- Background: PubMed 26337372Weber F, Van Beek S, Scoones G. Potential neurotoxicity of anesthetic drugs in young children: who cares? A survey among European anesthetists. Minerva Anestesiol. 2016 Mar;82(3):294-300. Epub 2015 Sep 3.
- Background: PubMed 26643428Chen X, Wan Y, Wen K, Liang T, Lin T, Li P. [Perioperative anesthetic exposure and the neurodevelopmental status of 1 year old baby underwent neonatal cardiac surgery]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Nov;40(11):1234-8. doi: 10.11817/j.issn.1672-7347.2015.11.012. Chinese.
- Background: PubMed 28607205Mebius MJ, Kooi EMW, Bilardo CM, Bos AF. Brain Injury and Neurodevelopmental Outcome in Congenital Heart Disease: A Systematic Review. Pediatrics. 2017 Jul;140(1):e20164055. doi: 10.1542/peds.2016-4055. Epub 2017 Jun 13.
- Background: PubMed 32365412Barnett AM, Machovec KA, Ames WA, Homi HM, Turi JL, Koo J, Fuller M, Jooste EH. The effect of intraoperative methadone during pediatric cardiac surgery on postoperative opioid requirements. Paediatr Anaesth. 2020 Jul;30(7):773-779. doi: 10.1111/pan.13903. Epub 2020 Jun 25.
- Background: PubMed 22791093Gupta P, Whiteside W, Sabati A, Tesoro TM, Gossett JM, Tobias JD, Roth SJ. Safety and efficacy of prolonged dexmedetomidine use in critically ill children with heart disease*. Pediatr Crit Care Med. 2012 Nov;13(6):660-6. doi: 10.1097/PCC.0b013e318253c7f1.
- Background: PubMed 27636695Edwards L, Brown LF. Nonpharmacologic Management of Neonatal Abstinence Syndrome: An Integrative Review. Neonatal Netw. 2016;35(5):305-13. doi: 10.1891/0730-0832.35.5.305.
- Background: PubMed 25062522Maguire D. Care of the infant with neonatal abstinence syndrome: strength of the evidence. J Perinat Neonatal Nurs. 2014 Jul-Sep;28(3):204-11; quiz E3-4. doi: 10.1097/JPN.0000000000000042.
- Background: PubMed 29414848Stuyt EB, Voyles CA, Bursac S. NADA Protocol for Behavioral Health. Putting Tools in the Hands of Behavioral Health Providers: The Case for Auricular Detoxification Specialists. Medicines (Basel). 2018 Feb 7;5(1):20. doi: 10.3390/medicines5010020.
- BackgroundAssociation NAD. Acupuncture Detoxification Specialist Training and Resource Manual. Fourth ed: NADA Literature Clearinghouse; 2015. 203 p.
- Individual participant dataSharing planned: No
Related trials for Iatrogenic Withdrawal Syndrome
RecruitingObservational study
IWS Diagnosis Criteria Consensus
Iatrogenic Withdrawal Syndrome
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.
Heather Jackson, MSN, APRN principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Iatrogenic Withdrawal Syndrome, run by Vanderbilt University Medical Center 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 3 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 21 Feb 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?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1) (time frame: Baseline to 72 hours). 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?
On the ClinicalTrials.gov record for NCT05025384, which also lists 29 linked publications.
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 21 Feb 2025.