Acupuncture for Opioid Use Disorder

(AcuPOM Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jessica Bayner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Albert Einstein College of Medicine

Must be taking: Methadone

Disqualifiers: Pending surgery, Relocation, Psychotic conditions, Pregnancy

No Placebo Group

Trial Summary

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

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you must be on a stable dose of methadone for at least 14 days before joining the study.

What data supports the effectiveness of this treatment for opioid use disorder?

Research on the National Acupuncture Detoxification Association (NADA) protocol, which is part of the treatment, shows it is widely used in the U.S. for substance abuse and behavioral health issues. Although studies have mixed results, it is considered a helpful addition to other treatments, potentially improving overall outcomes. ^{1 2 3 4 5}

Is acupuncture safe for treating opioid use disorder?

Research suggests that acupuncture, including the NADA protocol, is generally considered safe and acceptable for people undergoing withdrawal from opioids, although its effectiveness is still debated. ^{1 4 5 6 7}

How does the Modified Battlefield Acupuncture + NADA protocol treatment differ from other treatments for opioid use disorder?

This treatment is unique because it combines the Modified Battlefield Acupuncture, which targets specific points on the ear, with the NADA protocol, a widely used ear acupuncture method for substance abuse. Unlike standard drug treatments, this approach is non-pharmacological and focuses on holistic care, potentially enhancing the effects of other therapies. ^{1 5 8 9 10}

Research Team

Jessica Bayner, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for individuals with chronic pain who also struggle with opioid use disorder, including those experiencing mood swings. Participants should be interested in trying acupuncture as a treatment option.

Inclusion Criteria

I experience chronic pain with a severity of at least moderate.

Willingness to participate in all study components

Ability to provide informed consent

Exclusion Criteria

Have a pending or planned relocation or pending incarceration

I have a surgery or invasive pain procedure planned.

I do not have severe mental health issues that would stop me from participating.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a modified BFA + NADA treatment, twice per week over 4 weeks for a total of 8 treatments at the clinic. Small seeds are placed for at-home acupressure treatment.

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys assessing pain, physical functions, stress, mood, insomnia, and psychological changes.

2 weeks

Treatment Details

Interventions

• Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol (Behavioural Intervention)

Trial Overview The study tests the effectiveness of Modified Battlefield Acupuncture combined with the National Acupuncture Detoxification Association protocol on chronic pain, opioid dependency, and mood changes.

Participant Groups

Group I: BFA + NADA protocol Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Dr. Philip Ozuah

Albert Einstein College of Medicine

Chief Medical Officer since 2019

MD from University of Ibadan, Nigeria

Dr. Yaron Tomer

Albert Einstein College of Medicine

Chief Executive Officer since 2021

MD from Sackler School of Medicine, Tel Aviv University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

The NADA auricular acupuncture protocol, while not effective in reducing immediate opiate cravings or withdrawal symptoms, may help improve treatment retention and lower methadone dosages in individuals with opioid use disorder (OUD).

This systematic review analyzed four randomized trials and suggests that incorporating the NADA protocol as a complementary treatment could enhance recovery efforts and potentially reduce the overall health risks associated with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of auricular acupuncture in opioid use disorder: A systematic literature review. Baker, TE., Chang, G.[2022]

Acupuncture has shown potential benefits in treating opioid use disorder (OUD), particularly in reducing cravings, insomnia, and depression, based on a systematic review of nine studies with 1063 participants.

Electroacupuncture (EA) was found to significantly alleviate opioid cravings and depression symptoms, while transcutaneous acupoint electrical stimulation (TEAS) effectively improved insomnia and anxiety symptoms compared to sham treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Acupuncture for Treating Opioid Use Disorder in Adults: A Systematic Review and Meta-Analysis. Chen, Z., Wang, Y., Wang, R., et al.[2022]

A systematic review of 41 studies involving 5,227 participants found that acupuncture did not significantly reduce relapse rates or frequency and quantity of substance use compared to other treatments.

However, acupuncture showed a significant reduction in withdrawal/craving and anxiety symptoms immediately after treatment, although these benefits were not sustained in the long term and the evidence quality was low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for substance use disorders: A systematic review and meta-analysis. Grant, S., Kandrack, R., Motala, A., et al.[2022]

Only 5.5% of substance use disorder (SUD) treatment facilities in the US offer therapeutic acupuncture, indicating its limited availability as a treatment option.

Facilities that provide opioid treatment programs or specific pharmacotherapies like oral naltrexone or buprenorphine are more likely to offer acupuncture, suggesting a connection between these treatment modalities and the integration of complementary therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics associated with the availability of therapeutic acupuncture in substance use disorder treatment facilities in the United States. Qeadan, F., Madden, EF., Barbeau, WA., et al.[2023]

The NADA-standardized ear acupuncture protocol has become widely used for substance abuse and behavioral health, despite mixed research results regarding its efficacy.

Future research should focus on comparing the NADA protocol combined with standard treatments to those treatments alone, as NADA is not a standalone treatment but rather a psychosocial intervention that enhances overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National Acupuncture Detoxification Association protocol, auricular acupuncture to support patients with substance abuse and behavioral health disorders: current perspectives. Stuyt, EB., Voyles, CA.[2022]

This review will assess the effectiveness and safety of acupuncture in reducing opioid consumption among chronic pain patients, utilizing a comprehensive search of multiple databases and including randomized controlled trials.

The primary outcomes will focus on measuring the prescribed or consumed doses of opioids and any withdrawal symptoms, aiming to provide valuable insights for patients and healthcare providers regarding acupuncture as a supportive treatment in opioid tapering programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for reduction of opioid consumption in chronic pain: A systematic review and meta-analysis protocol. Lee, S., Jo, DH.[2023]

In a controlled study involving 100 individuals with heroin addiction, those receiving standard auricular acupuncture treatment attended more sessions and remained in treatment longer compared to those receiving a sham treatment.

The study suggests that acupuncture may be a beneficial treatment for heroin detoxification, particularly for individuals with lighter drug use habits, as their attendance at sessions correlated with reduced self-reported drug use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture heroin detoxification: a single-blind clinical trial. Washburn, AM., Fullilove, RE., Fullilove, MT., et al.[2022]

A meta-analysis of 20 trials indicates that acupuncture-related therapies, particularly manual acupuncture (MA), may be effective in treating opioid dependence in patients receiving methadone maintenance treatment (MMT), with MA showing superior efficacy compared to Western medicine (WM) and other acupuncture types.

Manual acupuncture was found to significantly reduce withdrawal symptoms more effectively than WM, electro-acupuncture, and transcutaneous electrical acupoint stimulation, suggesting it could be the best acupuncture option for opioid dependence treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for Opioid Dependence Patients Receiving Methadone Maintenance Treatment: A Network Meta-Analysis. Wen, H., Chen, R., Zhang, P., et al.[2023]

In a study involving 60 heroin addicts on methadone maintenance, true acupuncture significantly reduced daily methadone consumption compared to sham acupuncture, starting from week 2 of treatment.

True acupuncture also improved sleep quality, as indicated by better sleep latency scores, and all reported adverse events were mild, suggesting it is a safe adjunct therapy for heroin addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. Chan, YY., Lo, WY., Li, TC., et al.[2014]

Acupuncture is increasingly recognized as a safe and effective nonpharmacological treatment for pain management and as part of comprehensive strategies to address opioid use disorder, supported by large-scale studies and meta-analyses.

With 25% of U.S. hospitals and 88% of Veterans Health Administration facilities offering acupuncture, there is a growing feasibility for integrating this treatment into multi-disciplinary approaches for pain and opioid use, although challenges in implementation remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and Opioid Use: Evidence for Integrating Acupuncture Into Treatment Planning. Sommers, E., Vinjamury, SP., Noborikawa, J.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The use of auricular acupuncture in opioid use disorder: A systematic literature review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Acupuncture for Treating Opioid Use Disorder in Adults: A Systematic Review and Meta-Analysis. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Acupuncture for substance use disorders: A systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Characteristics associated with the availability of therapeutic acupuncture in substance use disorder treatment facilities in the United States. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

The National Acupuncture Detoxification Association protocol, auricular acupuncture to support patients with substance abuse and behavioral health disorders: current perspectives. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for reduction of opioid consumption in chronic pain: A systematic review and meta-analysis protocol. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Acupuncture heroin detoxification: a single-blind clinical trial. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Acupuncture for Opioid Dependence Patients Receiving Methadone Maintenance Treatment: A Network Meta-Analysis. [2023]

9. Singapore pubmed.ncbi.nlm.nih.gov

Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Pain and Opioid Use: Evidence for Integrating Acupuncture Into Treatment Planning. [2021]