Yvette Marie Miller, M.D. Executive Medical Officer American Red Cross, Donor and Client Support Center Charlotte, NC

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1 The Opioid Epidemic and Restorative Justice: The NADA Auricular Acupuncture Protocol October 24, 9:30 a.m. Kenneth Carter, M.D., M.P.H. Yvette Marie Miller, M.D. The Opioid Epidemic and Restorative Justice: National Acupuncture Detoxification Association (NADA) Protocol A Tool for Recovery in Opioid and Co-Occurring Disorders Kenneth Carter, M.D., M.P.H. Medical Director SalusCareFlorida Emergency, Acute Care & Residential Services Fort Myers, FL kcarter@saluscareflorida.org Yvette Marie Miller, M.D. Executive Medical Officer American Red Cross, Donor and Client Support Center Charlotte, NC yvette.miller@redcross.org 1

2 Session Objectives Examine the history of NADA Protocol in relation to addiction and treatment Learn how to integrate the NADA protocol into in a variety of settings including hospital and community based centers. Examine evidence based research for efficacy of NADA auricular acupuncture in treating patients with addictions and other behavioral health conditions. Restorative Justice Practices: Focus on Ear Acupuncture The John Marshall Law School Restorative Justice Project 2

3 NADA Video 7NzqB7p3s NADA Video 3

4 NADA Video CN2 ODcSGr0 NADA Video-CN2 4

5 Why auricular acupuncture In 1962, only 2% of the US population over the age of 12 years had tried an illegal drug By the mid 1980s, nearly 50% of the population had experimented with an illegal drug The annual number of persons with substance dependence or abuse in 2013 (21.6 million) Similar to the number in each year from 2002 through 2012 (ranging from 20.6 million to 22.7 million) 2013 National Survey on Drug Use and Health (NSDUH), U.S. Substance Abuse and Mental Health Services Administration (SAMHSA); What is NADA A nonprofit organization established in 1985 Multidisciplinary membership - 30% acupuncturists - Many other specialties including social workers, psychologists, physicians, CACs, mental health technicians, EMTs, MRCs 5

6 The NADA Organization Educates providers, stakeholders and policymakers Provides manual guided certification for NADA trainees Maintains bank of official Registered Trainers Provides administrative guidance through National NADA Office, Executive Director, and website support Understanding the ear Paul Nogier Central Figure France, early to mid 1950 s Systematic exploration and charting of entire ear using ohm meter Inflammation in the body mapped in corresponding areas of the ear by measuring change in electrical resistance on surface of the ear 92% correspondences btw foci of established body pathological and ear measurements 6

7 The First Peer Reviewed Report China, 1972 Dr. Wen s anecdotal observation Treating pain in neurosurgical patients post surgery using electrostimulation to bilateral ear Lung points Observed patients reporting amelioration of opiate withdrawal Lincoln Recovery Center Adopts Ear Acupuncture At first, copied Dr. Wen s Formula --Electro-acupuncture --Lung point only Wen, H. L. (1973). Treatment of drug addiction by acupuncture and electrical stimulation. 7

8 NADA Auricular Protocol Is best positioned as adjunctive therapy that clears the field for more specific treatment Can be administered to individuals but is best used in a (communal) group setting Provides balancing (homeostatic) and centering; Is not allopathic in nature or intention NADA 1974 to Present: An Organic Clinical Process Lincoln Hospital started by Dr. Michael Smith to address the heroin epidemic in NYC in the 1970s Experimentation to identify auricular points: Lung and Shenmen Lung associated with analgesia, sweating, and respiration. Lower half of ear innervated by vagus nerve. Shen Men - Regulates excitation and inhibition of the cerebral cortex and can produce sedation. mental clarity Sympathetic: Regulate disruption in both sympathetic and parasympathetic nervous systems. Kidney point: help methadone patients with edema Liver point: help liver function and inflammation 8

9 Why the Ear? 2 to 5 weeks Why the ear? Embryonic Development Embryonic gill plates develop into the external ear and are comprised of tissue from all 3 embryonic layers ectoderm mesoderm endoderm External ear is the only body structure where all 3 embryonic layers are represented. 9

10 Why the ear?: Embryonic Development Early development Regulatory systems basic to all life Vegetative systems basic to all life Gill plates become the ear Later development Central Nervous System Autonomic Nervous System Hypothalamic Pituitary Axis (HPA) External ear-- Spinal Cord Connections Ectodermal helix and lobe. Principal innervation via greater auricular nerve of the superior cervical plexus (C 1, C 2, C 3). Mesodermal base and upper pinna. Principal innervation via auriculotemporal branch of the anterior superior trigeminal nerve (C 5) which has sympathetic fibers. Endodermal concha Principal innervation via auricular branch of the vagus nerve (C X) which has sympathetic fibers. 10

11 Microsystem Correspondences External ear is one of many microsystems used to guide traditional Chinese medicine interventions. Other microsystems include e.g., radial and carotid pulses, tongue, face. Microsystems range from very simple to highly complex including the motor cortex and thalamus Millennial Chinese Texts on Ear Correspondences Su Wen and Ling Shu Both say, Yin meridian channels converge on the ear, Yang meridian channels pass through the ear Suggestive of the ear as having unique potential for Yin/Yang [Parasympathetic/Sympathetic?] balance 11

12 Other Mechanisms: Electromagnetic Theory Charge particles moving through space create electromagnetic waves. All minerals, sugars, proteins, RNA, DNA, etc., exist in the body as charged particles and impact the ear proximally and distally by generating electromagnetic waves Electromagnetic waves result in focused standing waveform patterns that impact/generate somatotypic regions Other Mechanisms: Specific Physiologic Effects Blood Flow Breathing Rate Endogenous peptides [eg, beta endorphin, metenkephalins, Neurotransmitters [eg serotonin, norepinephrine, dopamine and cortisol] Brewington, V. et al. Acupuncture as a detoxification treatment: A analysis of controlled research. Journal of substance abuse treatment11[4], Smith M O, Carter K O, et al. Ear acupuncture in addition treatment in B.A. Johnson [Ed.], Addiction Medicine. Science and practice. Vol

13 Nada Ear acupuncture in practice 1. Sympathetic 2. Shen men 3. Kidney 4. Liver 5. Lung

14 The First Peer Reviewed Report China, 1972 Dr. Wen s anecdotal observation Treating pain in neurosurgical patients post surgery using electrostimulation to bilateral ear Lung points Observed patients reporting amelioration of opiate withdrawal eeeeee 14

15 First NADA acudetox Publications Shakur, M., and Smith M.O. (1979) The use of acupuncture n the treatment of drug addiction. American Journal of Acupuncture, 7(3) Smith, M.O. (1979) Acupuncture and natural healing in drug detoxification. American Journal of Acupuncture. 7(2), Group process emphasized Universal Benefit Improvement in engagement and retention Relapse prevention Reduced alcohol and drug cravings, and withdrawal symptoms Benefit potential is substance and symptom neutral Associated with decrease in positive urine tests, increased program completion, improved patient satisfaction, and cost savings Bullock ML et al, (1989) Controlled Trial of Acupuncture for severe recidivist alcoholism Lancet, 1 (8652) , Santasiero, RP, Cost-Effectiveness of auricular acupuncture for treating substance abuse in an HMO setting: A pilot Study. Medical Acupuncture vol.16 no

16 Universal Benefit - Depression - Anxiety - Anger - Impaired concentration - Decreased energy - Body ache / Headaches Carter, K.O., Olshan-Perlmutter, M., Norton, H.J., & Smith, M.O. (2011) NADA prospective trial in patients with substance use disorders and seven common health symptoms. Medical Acupuncture (23)3, Universal Benefit Stress Impulsive Behaviors Trauma Harm reduction Individual and Group Psychotherapy (especially Mindfulness Based Therapies ) Carter K, Olshan-Perlmutter M. (2015) Impulsivity and Stillness: NADA, Pharmaceuticals, and Psychotherapy in Substance Use and Other DSM 5 Disorders Stuyt, E.B. Ear acupuncture for co-occurring substance abuse and borderline personality disorder: an aid to encourage treatment retention.and tobacco cessation. Acupuncture med 2014;32:

17 Universal Benefit NADA may help modify the risks associated with impulsivity and improve clinical outcomes Immediacy of effect makes it especially useful in acute situations- trauma and medical reserve corps [MRC] Non verbal, does not require learning curve Provided in a calm and supportive group setting to help mitigate impulsiveness Balancing experience, general sense of well-being 17

18 Interpreting conflicting research data Impossible to do double blind When is a sham really a sham NADA as an adjunctive psychosocial tool NADA Ear Acupuncture: An Adjunctive Therapy to Improve and Maintain Positive Outcomes in Substance Abuse Treatment Winthrop University/Keystone Substance Abuse Services Center in Rock Hill, South Carolina Objectives determine if NADA plus traditional treatment is better in improving and sustaining treatment outcomes including: quality of life and psychiatric symptoms, maintaining abstinence from drug, alcohol and tobacco, and decreasing healthcare utilization. Design -- Prospective, computer randomized, controlled study; [traditional Treatment] versus [ traditional Treatment + NADA Protocol] Setting -- Keystone Substance Abuse Service 32 week outpatient treatment setting in Rock Hill, SC Participants patients in each treatment arm (100 total) 18

19 Patients Were Randomized to Traditional Treatment or Traditional Treatment Plus NADA Protocol Traditional group: received all programs offered at KSS IOP substance abuse program which included: individual therapy, 12 Step orientation, and a variety of group therapies NADA group: Patients received 5 bilateral ear acupuncture points (NADA protocol) in a group setting twice weekly throughout there stay at KSS IOP substance abuse program in addition to traditional treatment Method UPON PROGRAM ADMISSION AND COMPLETION 1. Quality of Life and Satisfaction Questionnaire 2. PHQ-9 Depression Screening 3. GAD-7 General Anxiety Disorder Screen 4. Drug Screens UPON PROGRAM COMPLETION AND 3 AND 6 MONTH FOLLOW UP 1. Patients self-reported alcohol, tobacco, and drug use 2. Healthcare utilization 19

20 Nada Protocol Experience Treatment administered by a certified/licensed Acupuncture Detoxification Keystone Substance Abuse Services. 5 point auricular (ear) acupuncture while seated together in a group Needles are inserted at beginning of treatment hour and generally remain in place for minutes. Needles are provided in sterile packages, are single use, inserted once and discarded in designated sharps disposal containers. Needles are inserted with brief but steady movement, twirled 180 degrees for smoother insertion. Patients may request needle removal at any time during the treatment. Acupuncture treatments 2x/week and patients encouraged to attend all sessions. Patients will resume their normal treatment sessions following the acupuncture session. Informed Risks 1. You may be randomized to control group and have no acupuncture for your condition for 6 months. 2. It is possible that you receive acupuncture treatments but do not do as well as you have been doing. 3. Because the treatment is relatively new, we may not yet know all the side effects: something unexpected could happen. Known side effects Likely - Brief ear discomfort - Minimal local bleeding upon needle removal Less Likely - Local bruising - Metallic irritation from needle - Temporary headache Rare but Serious - Vaso-vagal response (fainting) 20

21 Results Patient characteristics: Completion/non-completion differ by race, criminal history and initial drug test categories. Among nonwhites a higher percentage completed the program in the NADA group. Among patients with a positive initial drug test a higher percentage complete the program in the NADA group. Among those with criminal history a higher percentage failed to complete the program in the control group 21

22 Results Psychological Improvement QLES: NADA group show a significant improvement in quality of life/q-les from entry to discharge. PHQ-9: Post hoc tests: selected items in the PHQ ( feeling tired or having energy and feeling bad about yourself or that you let your family down ) showed improvement for NADA group GAD-7: No statistical difference between groups 22

23 23

24 Maintaining Abstinence Both groups improved patients ability to maintain abstinence from alcohol drug and tobacco consumption between program entry and program completion. Alcohol: NADA group better maintained abstinence at 3 and 6 months compared to traditional group Drugs: No statistical difference Tobacco: NADA group better maintained abstinence at 6 months compared to traditional group 24

25 Additional Results Employment: 50% of patients in NADA group and 54.8% patients in control group who completed the program were unemployed upon entering the program. At discharge 71% of patients in NADA group who previously were unemployed had attained some type of employment vs. 35% of control group (χ2 =4.01, p<.05). Healthcare Utilization: No statistical difference Janssen PA, Demorest LC, Kelly A, Thiessen P, Abrahams R. (2012) Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol. Subst Abuse Treat Prev Policy, 7:48. RCT. Pregnant. Usual care (n=39) vs NADA added (n=50) Outcomes: With NADA, larger reductions in methadone dose pre-delivery, babies 2 less days of morphine, shorter duration of neonatal withdrawal symptoms. Problems: only 28% protocol compliance with NADA. 25

26 Stuyt EB. (2014). Ear acupuncture for co-occurring substance abuse and borderline personality disorder: an aid to encourage treatment retention and tobacco cessation. Acupunct Med., 32: Outcome study-90 day tobacco-free, dual dx inpatient. NADA voluntary 4x/wk. Use of NADA positively correlated w/successful program completion AND tobacco cessation for those with BPD. Most significant with BPD-- hypothesis, NADA helped with distress tolerance Bergdahl L, Berman AH, Haglund K. (2014) Patients experience of auricular acupuncture during protracted withdrawal. J Psych Men Health Nurs.,21: Qualitative study: 15 patients reporting NADA experiences. - No major AE. Some minor AE: pain w/insertion, timeconsuming. - Many PE: Reduced w/d sx and cravings Improved sleep Peacefulness Increased well-being Increased energy Decreased physical discomfort Decreased irritability 26

27 Reilly PM, Buchanan TM, Vafides C, Breakey S, Dykes P. (2014) Auricular acupuncture to relieve health care workers stress and anxiety. Dimens Crit Care Nurs.,33(3): Mixed methods. Vol/non-randomized. NADA 1x/wk x 16 wks. Pop: Healthcare workers on surgical burn/trauma units Methods: pre/post surveys anxiety, burnout & compassion fatigue. Significant reduction in state anxiety, trait anxiety, burnout and compassion fatigue compared to baseline. NADA Protocol and State Laws NADA policies vary widely from state to state Some states are very restrictive, severely limiting who may provide and supervise NADA protocol services. NADA availability is accessible with general supervision requirement Direct supervision limits access as it requires a physician or acupuncturist to be present on site 27

28 Animal model of NADA 28

29 Opioid-Induced Adverse Effects ADDICTION DRUG SEEKING BEHAVIOR LOCOMOTOR SENSITIZATION OPIOID-INDUCED HYPERALGESIA PARADOXICAL PAIN SENSITIZATION ANALGESIC TOLERANCE Animal experiments on acupuncture treatment for addiction Acupuncture treatment can activate GABA B receptors on the dopamine cell body and presynaptic κ-opioid receptors in the nucleus accumbens through dynorphin neurons, Decreased dopamine release and overall positive reinforcement 1. Yoon, S. S., Kwon, Y. K., Kim, M. R., et al. (2004) Acupuncture-mediated inhibition of ethanol-induced dopamine release in the rat nucleus accumbens through the GABAB receptor. Neurosci Lett, 369(3): Kiianmaa, K., Hyytia, P., Samson 29

30 Kailasam VK, Anand P, Melyan Z. (2016) Establishing an animal model for National Acupuncture Detoxification Association (NADA) auricular acupuncture protocol. Neurosci Lett., 624: Animal Study. Morphine-dependent rats. NADA vs 5 sham helix. Interdermal min x 6 days Authors conclusions: NADA acupuncture treatment can reduce morphineinduced locomotor sensitization (indication of craving) Prevent the development of morphine tolerance in rats Validates NADA for craving reduction NADA could be helpful with human opioid chronic pain management. Acupressure Seeds and Magnets Magnetized metal beads Vaccaria seeds Can use single point Shen Men or point directly behind it reverse Shen Men Provides calming effect,promotes relaxation and sedation ;regulates and stabilizes emotions Noninvasive -more gentle intervention More prolonged way to provide stimulation and support 30

31 Benefits Administered to neonates/children Trauma/Disaster situations Preliminary data helpful anxiety/pain/cravings/adhd Noninvasive and easy to administer Risks Local bruising Irritation from the hypoallergenic tape Temporary scalp discomfort Temporary headache Ingest 2 or more magnets could cause intestinal blockage even death Keep distance from heart pacemakers Allergy to magnets that are nickel plated 31

32 Kuo SY, Tsai SH, Chen SL, Tzeng YL. Auricular acupressure relieves anxiety and fatigue, and reduces cortisol levels in post-cesarean section women: a single-blind, randomized controlled study. Int J Nurs Stud.2016;53:17-26 RCT Post-cesarean section in hospital care x 5 days UC (n=37) vs UC + Shen Men seeds pressure 2x/day (n=39) Acupressure sign diff in validated tool self ratings of anxiety and fatigue; decreased HR, and mean serum cortisol levels. Tian, X., Kirshnan, S., EFFICACY OF AURICULAR ACUPRESSURE AS AN ADJUNCT THERAPY IN SUBSTANCE TREATMENT: A PILOT STUDY (2006) vol 12, no. 1 Placebo controlled single blinded, 6 week trial UC, UC t acupressure group, UC t placebo control group N=6 acupressure group N=6 placebo N=5 UC Positive response acupressure group in reducing emotional distress (Hopkins symptom checklist depression scale) and cravings Brief substance craving scale, compared to UC Did not distinguish from placebo acupressure group 32

33 Best Practices Center for Substance Abuse Treatment. (2006). Center for substance abuse treatment detoxification and substance abuse treatment. TIP series (45) (DHHS Publication No. [SMA] ). Rockville, MD: Substance Abuse and Mental Health Services. Best Practices 2012 Department of Veteran Affairs & Department of Defense the evidence is good Post Traumatic Stress Disorder - Depression - Anxiety - Addiction, co-occurring disorders retrieved from 33

34 Process Improvements and Take Aways 1. NADA protocol is an effective adjunctive treatment for improving outcomes for patients with substance use disorders as well as co-occurring behavioral health issues 2. It is easy and safe to use 3. As a non verbal intervention NADA offers a unique opportunity for patient engagement and retention 4. Permissive regularity statutes minimize treatment barriers for patients, providers and programs. 5. The standardized NADA training opportunity's and resources are available nationally and internationally at Acudetox ( Practitioners, Locations & Training opportunity Practitioners Lay, nurses, SWs, psychologists, CACs, MDs, acupuncturists, etc. Locations 500 US addictions programs using acupuncture Locations worldwide Carter K., Olshan-Perlmutter M. (2014) NADA Protocol Integrative Acupuncture in Addictions. Journal of Addictions Nursing. Vol 25. no. 4,

35 STRATEGY for TRIALS KEEP IT SIMPLE: (Business as usual) vs (Business as usual + NADA) 35

36 36

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