Chronic PainAcuPOMNCT06543355

The Acupuncture for Pain, Opioid Use Disorder and Mood

A study testing Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol in people with Chronic Pain and Opioid Use Disorder, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain, Opioid Use Disorder, Mood Change
What is being tested?: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2025to 4 Jun 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 years old,
English proficiency;
receiving methadone treatment at an OTP through the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability;
chronic pain of at least moderate pain severity (score of at least 4 on the Pain, Enjoyment of Life and General Activity (PEG) scale);
willingness to participate in all study components; and
ability to provide informed consent

Who cannot join

Have pending surgery or invasive pain management procedure;
Have a pending or planned relocation;
have an acutely or exacerbation of psychotic, suicidal, or homicidal conditions that preclude the ability to participate; and
pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Division of Substance Abuse (DoSA) Wellness Center at Melrose
The Bronx, New York, 10451

Other trials in United States

About this study

Official title: The Acupuncture for Pain, Opioid Use Disorder and Mood (AcuPOM) Study: A Pilot Trial

The goal of this study is to determine how patients with chronic pain and opioid use disorder will respond to treatment with acupuncture, including whether there will be any changes in mood (as an exploratory outcome). Results from this study have the potential to inform future studies in patients who would consider using acupuncture as an intervention for their conditions.

Read the detailed description

In this 4-week pilot study, the feasibility of recruiting a sample of participants in a modified Battlefield Acupuncture + National Acupuncture Detoxification Association (BFA + NADA) protocol will be assessed. Utilizing a novel BFA (Battlefield Acupuncture) plus a NADA (National Acupuncture Detoxification Association) protocol, approximately 20 participants with chronic pain and Opioid Use Disorder (OUD), receiving Methadone through an Opioid Treatment Program (OTP) at Montefiore Medical Center, will be recruited. Each participant will receive a modified BFA + NADA treatment, twice per week over 4 weeks for a total of 8 treatments at the clinic. All participants will also have the small seeds placed to facilitate at-home acupressure treatment. In this feasibility study, the investigator team will collect feasibility data from each participant at every session over the course of 4 weeks. Feasibility outcomes are defined in the Outcome Measures of this registration. As part of the study, the following will also be monitored to explore preliminary efficacy: (1) pain intensity and physical functioning, (2) opioid cravings and substance use, and (3) mood, insomnia, and stress. The research team will conduct surveys assessing pain, physical functions, the changes in stress, mood, insomnia and psychological changes at baseline, and before and after every treatment. These will all be exploratory as this is a feasibility study.

Note: Following discussions with the Principal Investigator and Sponsor this study was re-categorized as a feasibility study.

Conditions: Chronic Pain, Opioid Use Disorder, Mood Change, Opioid Misuse, Opioid-Related Disorders
Being tested: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol
Keywords: Acupuncture
Medical subject headings: Chronic Pain, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocolDevice
The delivery of modified BFA + NADA will be administered in a setting designed to ensure that patients are comfortable, with their backs well-supported. With regards to needling technique, participants' ears will be cleaned, and sterile acupuncture needles will be placed on the BFA or NADA points, using proper technique. Auricular acupuncture needles are thin, between 0.12 - 0.18mm, and are less than 1 inch long. The needles will remain in the ear until the session is complete. On the alternative ear, seeds are another modality of auricular acupuncture treatment that will be used. Seeds are comprised of small circular balls comprised of a natural plant, no more than 1.5 mm diameter size. The seeds are attached to a small piece of adhesive tape and are placed on one's ear. The seeds remain on the ear and the given point can be massaged and stimulated as indicated.

Study groups in NCT06543355
Study group	Role	What they receive
BFA + NADA protocol	Experimental	Modified BFA + NADA treatment, twice per week over 4 weeks for a total of 8 treatments at the clinic. All participants will also have the small seeds placed to facilitate at-home acupressure treatment Receives: Device: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility - Percentage Consented
The percentage of total participants screened who have been consented will be calculated and reported.
Measured: During the informed consent process, prior to the intervention
Feasibility - Percentage Retained
The percentage of total participants consented who complete the study will be calculated and reported.
Measured: Upon completion of the study, up to four weeks
Adherence to acupuncture treatments
Adherence to acupuncture treatments treatments will also be used to assess feasibility. Adherence the intervention will be defined as the percentage of participants who completed all scheduled acupuncture treatments. Adherence will be successful if participants attend at least 50% of acupuncture treatments.
Measured: At 0, 2, and 4 week study visits, up to four weeks total
Acceptability/Satisfaction
Acceptability of and Satisfaction with the intervention will be assessed using a single outcome measure, the Patient Global Impression of Change Scale. This scale consists of a single question asking the participant to rate acceptability/satisfaction of the intervention on a seven-point scale ranging from 1 (= very much better) to 7 ( = very much worse). Higher scores are associated with less favorable participant perceptions of the intervention. Group mean scores will be summarized.
Measured: Upon completion of the study, up to four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 20254 Jun 2025

First posted9 Aug 2024
Study start6 Jan 2025
Primary completion4 Jun 2025
Study completion4 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies 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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Model description: Acupuncture
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06543355
Sponsor's protocol ID: 2024-15724
Other IDs: 4RM1DA055437-02
Acronym: AcuPOM
Status last verified: Aug 2025
First submitted: 2 Aug 2024
Last updated: 28 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.
PubMed 30212442
Patel M, Urits I, Kaye AD, Viswanath O. The role of acupuncture in the treatment of chronic pain. Best Pract Res Clin Anaesthesiol. 2020 Sep;34(3):603-616. doi: 10.1016/j.bpa.2020.08.005. Epub 2020 Aug 8.
PubMed 33004170
Lua, P. L., & Talib, N. S. (2012). The effectiveness of auricular acupuncture for drug addiction: a review of research evidence from clinical trials. ASEAN Journal of Psychiatry, 13(1), 55-68.
Romoli, M. Ear acupuncture: historical abstract-differences of ear cartography between the east and the west. Dtsch. Z. Akupunkt. 53: 24-33, 2010.
Stuyt EB, Voyles CA. The National Acupuncture Detoxification Association protocol, auricular acupuncture to support patients with substance abuse and behavioral health disorders: current perspectives. Subst Abuse Rehabil. 2016 Dec 7;7:169-180. doi: 10.2147/SAR.S99161. eCollection 2016.
PubMed 27994492
Niemtzow, R.C., Battle- field acupuncture. Med. Acupunct. 19: 225-228, 2007.
Montgomery AD, Ottenbacher R. Battlefield Acupuncture for Chronic Pain Management in Patients on Long-Term Opioid Therapy. Med Acupunct. 2020 Feb 1;32(1):38-44. doi: 10.1089/acu.2019.1382. Epub 2020 Feb 3.
PubMed 32110262
Lin LL, Li HP, Yang JW, Hao XW, Yan SY, Wang LQ, Yu FT, Shi GX, Liu CZ. Acupuncture for Psychological Disorders Caused by Chronic Pain: A Review and Future Directions. Front Neurosci. 2021 Jan 27;14:626497. doi: 10.3389/fnins.2020.626497. eCollection 2020.
PubMed 33584181
Huang KW, Ochandarena NE, Philson AC, Hyun M, Birnbaum JE, Cicconet M, Sabatini BL. Molecular and anatomical organization of the dorsal raphe nucleus. Elife. 2019 Aug 14;8:e46464. doi: 10.7554/eLife.46464.
PubMed 31411560
Smith MO, Khan I. An acupuncture programme for the treatment of drug-addicted persons. Bull Narc. 1988;40(1):35-41.
PubMed 3219455
Mao JJ, Liou KT, Baser RE, Bao T, Panageas KS, Romero SAD, Li QS, Gallagher RM, Kantoff PW. Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):720-727. doi: 10.1001/jamaoncol.2021.0310.
PubMed 33734288
Levy CE, Casler N, FitzGerald DB. Battlefield Acupuncture: An Emerging Method for Easing Pain. Am J Phys Med Rehabil. 2018 Mar;97(3):e18-e19. doi: 10.1097/PHM.0000000000000766. No abstract available.
PubMed 28570280
Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
PubMed 22965186
Richard C. Niemtzow.Battlefield Acupuncture.Medical Acupuncture.Dec 2007.225- 228.http://doi.org/10.1089/acu.2007.0603
Litscher G. Ear Acupuncture according to the NADA (National Acupuncture Detoxification Association). Medicines (Basel). 2019 Mar 31;6(2):44. doi: 10.3390/medicines6020044.
PubMed 30935106

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Acupuncture for Pain, Opioid Use Disorder and Mood (AcuPOM) Study: A Pilot Trial
ClinicalTrials.gov ID: NCT06543355
Acronym / sponsor ID: AcuPOM / 2024-15724
Conditions: Chronic Pain, Opioid Use Disorder, Mood Change, Opioid Misuse, Opioid-Related Disorders
Keywords: Acupuncture
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Albert Einstein College of MedicineUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 6 Jan 2025 (actual)
Primary completion: 4 Jun 2025 (actual)
Study completion: 4 Jun 2025 (actual)
First posted: 9 Aug 2024 (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.

Detailed description

Note: Following discussions with the Principal Investigator and Sponsor this study was re-categorized as a feasibility study.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Acupuncture

Arm	Type	Receives
BFA + NADA protocol	Experimental	Device: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocolModified BFA + NADA treatment, twice per week over 4 weeks for a total of 8 treatments at the clinic. All participants will also have the small seeds placed to facilitate at-home acupressure treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥18 years old,
English proficiency;
receiving methadone treatment at an OTP through the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability;
chronic pain of at least moderate pain severity (score of at least 4 on the Pain, Enjoyment of Life and General Activity (PEG) scale);
willingness to participate in all study components; and

Key exclusion criteria (4 listed)

Have pending surgery or invasive pain management procedure;
Have a pending or planned relocation;
have an acutely or exacerbation of psychotic, suicidal, or homicidal conditions that preclude the ability to participate; and
pregnancy

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
Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocolThe delivery of modified BFA + NADA will be administered in a setting designed to ensure that patients are comfortable, with their backs well-supported. With regards to needling technique, participants' ears will be cleaned, and sterile acupuncture needles will be placed on the BFA or NADA points, using proper technique. Auricular acupuncture needles are thin, between 0.12 - 0.18mm, and are less than 1 inch long. The needles will remain in the ear until the session is complete. On the alternative ear, seeds are another modality of auricular acupuncture treatment that will be used. Seeds are comprised of small circular balls comprised of a natural plant, no more than 1.5 mm diameter size. The seeds are attached to a small piece of adhesive tape and are placed on one's ear. The seeds remain on the ear and the given point can be massaged and stimulated as indicated.	Device	BFA + NADA protocol

Primary outcome

Feasibility - Percentage Consented
Time frame: During the informed consent process, prior to the intervention
The percentage of total participants screened who have been consented will be calculated and reported.
Feasibility - Percentage Retained
Time frame: Upon completion of the study, up to four weeks
The percentage of total participants consented who complete the study will be calculated and reported.
Adherence to acupuncture treatments
Time frame: At 0, 2, and 4 week study visits, up to four weeks total
Adherence to acupuncture treatments treatments will also be used to assess feasibility. Adherence the intervention will be defined as the percentage of participants who completed all scheduled acupuncture treatments. Adherence will be successful if participants attend at least 50% of acupuncture treatments.
Acceptability/Satisfaction
Time frame: Upon completion of the study, up to four weeks
Acceptability of and Satisfaction with the intervention will be assessed using a single outcome measure, the Patient Global Impression of Change Scale. This scale consists of a single question asking the participant to rate acceptability/satisfaction of the intervention on a seven-point scale ranging from 1 (= very much better) to 7 ( = very much worse). Higher scores are associated with less favorable participant perceptions of the intervention. Group mean scores will be summarized.

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 28 Aug 2025.
Background: PubMed 30212442Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.
Background: PubMed 33004170Patel M, Urits I, Kaye AD, Viswanath O. The role of acupuncture in the treatment of chronic pain. Best Pract Res Clin Anaesthesiol. 2020 Sep;34(3):603-616. doi: 10.1016/j.bpa.2020.08.005. Epub 2020 Aug 8.
BackgroundLua, P. L., & Talib, N. S. (2012). The effectiveness of auricular acupuncture for drug addiction: a review of research evidence from clinical trials. ASEAN Journal of Psychiatry, 13(1), 55-68.
BackgroundRomoli, M. Ear acupuncture: historical abstract-differences of ear cartography between the east and the west. Dtsch. Z. Akupunkt. 53: 24-33, 2010.
Background: PubMed 27994492Stuyt EB, Voyles CA. The National Acupuncture Detoxification Association protocol, auricular acupuncture to support patients with substance abuse and behavioral health disorders: current perspectives. Subst Abuse Rehabil. 2016 Dec 7;7:169-180. doi: 10.2147/SAR.S99161. eCollection 2016.
BackgroundNiemtzow, R.C., Battle- field acupuncture. Med. Acupunct. 19: 225-228, 2007.
Background: PubMed 32110262Montgomery AD, Ottenbacher R. Battlefield Acupuncture for Chronic Pain Management in Patients on Long-Term Opioid Therapy. Med Acupunct. 2020 Feb 1;32(1):38-44. doi: 10.1089/acu.2019.1382. Epub 2020 Feb 3.
Background: PubMed 33584181Lin LL, Li HP, Yang JW, Hao XW, Yan SY, Wang LQ, Yu FT, Shi GX, Liu CZ. Acupuncture for Psychological Disorders Caused by Chronic Pain: A Review and Future Directions. Front Neurosci. 2021 Jan 27;14:626497. doi: 10.3389/fnins.2020.626497. eCollection 2020.
Background: PubMed 31411560Huang KW, Ochandarena NE, Philson AC, Hyun M, Birnbaum JE, Cicconet M, Sabatini BL. Molecular and anatomical organization of the dorsal raphe nucleus. Elife. 2019 Aug 14;8:e46464. doi: 10.7554/eLife.46464.
Background: PubMed 3219455Smith MO, Khan I. An acupuncture programme for the treatment of drug-addicted persons. Bull Narc. 1988;40(1):35-41.
Background: PubMed 33734288Mao JJ, Liou KT, Baser RE, Bao T, Panageas KS, Romero SAD, Li QS, Gallagher RM, Kantoff PW. Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):720-727. doi: 10.1001/jamaoncol.2021.0310.
Background: PubMed 28570280Levy CE, Casler N, FitzGerald DB. Battlefield Acupuncture: An Emerging Method for Easing Pain. Am J Phys Med Rehabil. 2018 Mar;97(3):e18-e19. doi: 10.1097/PHM.0000000000000766. No abstract available.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

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.

Jessica Bayner, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 28 Aug 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?

Feasibility - Percentage Consented (time frame: During the informed consent process, prior to the intervention). The study lists 4 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 NCT06543355, which also lists 24 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 28 Aug 2025.