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

Albert Einstein College of Medicine

Status: Enrolling

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

Treatments: Device: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06543355

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

2024-15724

Details and patient eligibility

About

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. Results from this study have the potential to inform future studies in patients who would consider using acupuncture as an intervention for their conditions.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

BFA + NADA protocol

Experimental group

Description:

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

Treatment:

Device: Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol