The Acupuncture for Pain, Opioid Use Disorder and Mood (AcuPOM)

August 22, 2025 updated by: Albert Einstein College of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18 years old,
  2. English proficiency;
  3. 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;
  4. chronic pain of at least moderate pain severity (score of at least 4 on the Pain, Enjoyment of Life and General Activity (PEG) scale);
  5. willingness to participate in all study components; and
  6. ability to provide informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BFA + NADA protocol
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the informed consent process, prior to the intervention
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.
Upon completion of the study, up to four weeks
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.
At 0, 2, and 4 week study visits, up to four weeks total
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.
Upon completion of the study, up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Jessica Bayner, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Actual)

June 4, 2025

Study Completion (Actual)

June 4, 2025

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-15724
  • 4RM1DA055437-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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