The Acupuncture for Pain, Opioid Use Disorder and Mood

NCT06543355 | Completed FDA Device

• 2 other identifiers: 2024-157244RM1DA055437-02
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Opioid Use Disorder; Mood Change; Opioid Misuse; Opioid-Related Disorders

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (4)

• Feasibility - Percentage Consented

  The percentage of total participants screened who have been consented will be calculated and reported.

  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.

  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.

  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.

  Upon completion of the study, up to four weeks

Study Arms (1)

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

Device: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol

Interventions

Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol DEVICE

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.

BFA + NADA protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Montefiore Division of Substance Abuse (DoSA) Wellness Center at Melrose

The Bronx, New York, 10451, United States

Location

Related Publications (24)

• 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.

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• 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.

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• 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.

  BACKGROUND

• Romoli, M. Ear acupuncture: historical abstract-differences of ear cartography between the east and the west. Dtsch. Z. Akupunkt. 53: 24-33, 2010.

  BACKGROUND

• 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.

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• Niemtzow, R.C., Battle- field acupuncture. Med. Acupunct. 19: 225-228, 2007.

  BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

  PMID: 33734288 BACKGROUND

• 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.

  PMID: 28570280 BACKGROUND

• 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.

  PMID: 22965186 BACKGROUND

• Richard C. Niemtzow.Battlefield Acupuncture.Medical Acupuncture.Dec 2007.225- 228.http://doi.org/10.1089/acu.2007.0603

  BACKGROUND

• Litscher G. Ear Acupuncture according to the NADA (National Acupuncture Detoxification Association). Medicines (Basel). 2019 Mar 31;6(2):44. doi: 10.3390/medicines6020044.

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• Garland EL, Hudak J, Hanley AW, Nakamura Y. Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. Am Psychol. 2020 Sep;75(6):840-852. doi: 10.1037/amp0000638.

  PMID: 32915027 BACKGROUND

• Carr DJ. The safety of obstetric acupuncture: forbidden points revisited. Acupunct Med. 2015 Oct;33(5):413-9. doi: 10.1136/acupmed-2015-010936. Epub 2015 Sep 11.

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• Cook KF, Jensen SE, Schalet BD, Beaumont JL, Amtmann D, Czajkowski S, Dewalt DA, Fries JF, Pilkonis PA, Reeve BB, Stone AA, Weinfurt KP, Cella D. PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol. 2016 May;73:89-102. doi: 10.1016/j.jclinepi.2015.08.038. Epub 2016 Mar 4.

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• Boyett B, Wiest K, McLeod LD, Nelson LM, Bickel WK, Learned SM, Heidbreder C, Fudala PJ, Le Moigne A, Zhao Y. Assessment of craving in opioid use disorder: Psychometric evaluation and predictive validity of the opioid craving VAS. Drug Alcohol Depend. 2021 Dec 1;229(Pt B):109057. doi: 10.1016/j.drugalcdep.2021.109057. Epub 2021 Sep 24.

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• Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.

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  PMID: 3418484 BACKGROUND

• Tanay G, Bernstein A. State Mindfulness Scale (SMS): development and initial validation. Psychol Assess. 2013 Dec;25(4):1286-99. doi: 10.1037/a0034044. Epub 2013 Sep 23.

  PMID: 24059475 BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jessica Bayner, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Acupuncture

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 9, 2024
• Study Start: January 6, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)