Acupuncture for Opioid Use Disorder

(AcuPOM Trial)

No longer recruiting at 1 trial location

Overseen By Hector R. Perez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must be taking: Methadone

Disqualifiers: Pending surgery, Relocation, Psychotic conditions, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can help individuals with chronic pain and opioid use disorder. The study examines how acupuncture might affect pain levels and mood. Participants will receive a specific type of acupuncture treatment, known as Modified Battlefield Acupuncture combined with the National Acupuncture Detoxification Association protocol, twice a week for four weeks. Suitable candidates include those on stable methadone treatment for at least 12 weeks and experiencing moderate chronic pain. As an unphased trial, this study provides a unique opportunity to explore alternative pain management options.

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 prior data suggests that this acupuncture protocol is safe for patients with opioid use disorder?

Research has shown that acupuncture, including the NADA protocol, is generally safe for individuals undergoing opioid withdrawal. Many organizations that manage addiction treatment widely accept the NADA protocol as a safe and effective method.

Studies indicate that Modified Battlefield Acupuncture combined with NADA is well-tolerated, with participants not experiencing serious side effects. These studies have reported no major safety concerns.

Overall, acupuncture maintains a strong safety record, making it a promising option for those interested in this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using acupuncture for opioid use disorder because it offers a non-pharmaceutical approach that could reduce reliance on medications like methadone or buprenorphine. This treatment combines Modified Battlefield Acupuncture and the National Acupuncture Detoxification Association protocol, which involves specific ear acupuncture points that may help reduce cravings and withdrawal symptoms. By incorporating acupressure seeds for at-home use, this approach empowers patients with a self-care tool that could enhance their recovery experience.

What evidence suggests that this acupuncture protocol is effective for opioid use disorder?

Research has shown that combining Modified Battlefield Acupuncture with the National Acupuncture Detoxification Association (NADA) protocol, which participants in this trial will receive, may aid individuals with opioid use disorder. The NADA protocol has been linked to noticeable improvements in symptoms such as cravings and depression. Although it might not significantly reduce sudden cravings or withdrawal symptoms, it can enhance overall well-being. Some studies have found that NADA acupuncture can improve mood and other symptoms when used alongside traditional treatments. While more research is needed, current evidence suggests it could be a useful additional approach for those dealing with opioid use and chronic pain. ^{2 3 6 7 8}

Who Is on the Research Team?

Jessica Bayner, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Modified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol

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.

How Is the Trial Designed?

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+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5153313/

The National Acupuncture Detoxification Association ... They found that patients reported the addition of NADA facilitated significant reduction in all symptoms measured including cravings, depression ...

2. trial.medpath.com trial.medpath.com/clinical-trial/a48c972d0391f3de/nct06543355-acupuncture-pain-opioid-mood-study

The Acupuncture for Pain, Opioid Use Disorder and Mood 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6630623/

Ear Acupuncture according to the NADA (National ... The results indicated that while the NADA protocol may not be effective in reducing acute opiate craving or withdrawal, it may be effectively ...

4. liebertpub.com liebertpub.com/doi/10.1089/acu.2010.0784

NADA Acupuncture Prospective Trial in Patients with ... Results: NADA acupuncture plus conventional treatment was associated with statistically significant improvement (p=0.0001) across all symptom ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460320306183

Randomized controlled three-arm study of NADA ... NADA acupuncture improved cardiac autonomic function in patients with alcohol addiction. · The treatment was not able to modulate craving or abstinence. · The ...

6. withpower.com withpower.com/trial/phase-substance-related-disorders-7-2024-d9f10

Acupuncture for Opioid Use Disorder (AcuPOM Trial) Research suggests that acupuncture, including the NADA protocol, is generally considered safe and acceptable for people undergoing withdrawal from opioids, ...

7. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06543355

The Acupuncture for Pain, Opioid Use Disorder and Mood ... The goal of this study is to determine how patients with chronic pain and opioid use disorder will respond to treatment with acupuncture, ...

8. alliedhealth.ceconnection.com alliedhealth.ceconnection.com/files/NADAProtocolIntegrativeAcupunctureinAddictions-1419263411853.pdf

NADA Protocol - CEConnection for Allied Health This safe, effective, and cost-efficient procedure has gained increasing acceptance from agencies responsible for overseeing addiction treatment over the past ...