Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study

Abstract

Objective: The purpose of this study was to integrate acupuncture within the standard of care during outpatient opioid tapering and assess impact of this treatment on cumulative withdrawal symptoms, psychologic distress, and pain.

Methods: This prospective randomized controlled pilot study administered the National Acupuncture Detoxification Association protocol following monthly opioid tapering. A total of 9 participants were randomized into the intervention group and compared with 6 participants who underwent the standard of care for outpatient opioid tapering. All providers prescribing medication management to both groups were blinded. Psychologic distress was evaluated using the hospital anxiety and depression scale (HADS). The clinical institute narcotic assessment (CINA) measured subjective withdrawal symptoms and pain was assessed using the numerical rating scale (NRS).

Results: Overall anxiety appeared slightly higher in the acupuncture group (HADS 7.0 compared with 6.5), however, depression was lower when compared with the standard of care group (HADS 4.0 compared with 6.5). The standard of care group reported more intense withdrawal symptoms (CINA 9.0 compared with 3.5) as well as higher pain scores (NRS 6.5 compared with 5.0). There were no statistically significant differences among the standard of care and acupuncture groups.

Conclusions: This study suggests that auricular acupuncture may be implemented within the standard of care for patients undergoing outpatient opioid weaning regimens. Although results were not statistically significant, they support future research and reveal a promising expansion of treatment options for patients physically dependent on opioid medication. Clinical Trials.gov ID: NCT02882048.

Introduction

The opioid epidemic has waged war on the United States for close to 2 decades with 33,000 American deaths occurring in 2015 alone.¹ A recent report by the U.S. Council of Economic Advisors estimated the cost of opioid crisis to be $2.5 trillion from 2015 to 2018 when accounting for increased health care costs, lost productivity, criminal prosecutions, and lost earning potential due to premature death or disability.² These numbers are astounding and emphasize the need for further strategies to assist patients and providers in safely weaning opioids when these medications are deemed unnecessary or even detrimental to their goals of improved functionality and engagement in society.

When evaluating the economic and societal costs, the trend of opioids prescribing in the United States provides a unique quantitative evolution of the crisis. The number of opioid prescriptions in the United States increased from 76 million to 219 million over a 10-year period from 1991 to 2011.³ Opioid prescriptions peaked in 2012 at 255 million and subsequently decreased to 168 million prescriptions in 2018.³ As providers in the United States furiously work to curb the tide of opioid prescriptions, they are also faced with the difficult task of tapering patients when this is deemed appropriate or necessary in the setting of chronic noncancer pain (CNCP).

Opioid tapering can elicit significant concerns from patients who have been maintained on this therapy for years of even decades despite a clear indication of benefit. Withdrawal symptoms and increased pain are 2 of the primary short-term concerns for patients,⁴ and, if severe, can lead to patient dropout or weaning failure. Treatment of opioid withdrawal with α₂ agonists is recommended to mitigate withdrawal symptoms⁵; however, these medications are not always sufficient or can have intolerable side-effects for patients. Acupuncture provides a unique option for both patients and providers to facilitate opioid tapering while lessening the symptoms of withdrawal and providing a treatment option for CNCP.⁶

Auricular acupuncture has long been used as an effective adjunct in the treatment of substance use disorder.^7–12 Predictably this treatment option has gained favor in treatment of opioid use disorder including detoxification. A rapid detoxification strategy along with auricular electroacupuncture and naloxone therapy has shown promise with no adverse side-effects reported.¹³ Alternatively, a systematic review article specifically evaluating the use of auricular acupuncture in opioid use disorder noted no difference in opioid cravings or withdrawal symptoms but did find evidence to support enhanced retention and decreased methadone dosage for maintenance therapy (n = 4).¹⁴ Although it was noted the 4 studies included in the review had significant methodological concerns including patients at different stages of detoxification, varying control groups, and challenges with randomization and blinding.

Given the paucity of well-designed studies, it is difficult to draw assumptions regarding the efficacy of auricular acupuncture in the treatment of opioid tapering in the outpatient setting for CNCP. This pilot study was specifically developed to determine whether the application of National Acupuncture Detoxification Association (NADA) protocol for auricular acupuncture could serve as a valuable tool to improve efficacy of opioid tapering for CNCP while avoiding significant withdrawal symptoms or patient dropout.

Methods

Design

This was a prospective randomized controlled pilot study approved by the Vanderbilt University Medical Center (VUMC) institutional review board (160725). The main objective of this study was to evaluate the feasibility and impact of the NADA protocol on outpatient opioid weaning in the adult chronic pain patient population. Three aims guided this study and included the influence of the NADA protocol on overall withdrawal symptoms, psychologic distress, and pain. Baseline data were obtained from each participant upon enrollment and reassessed with subsequent follow-up appointments. Opioid medication regimens were converted to morphine equivalent dose (MED) so as to provide a consistent measure of each participant's weaning progress. Given the anxiety producing nature of implementing an opioid weaning plan of care, anxiety, and depression were assessed with the hospital anxiety and depression scale (HADS).¹⁵ Opioid weaning regimens consistent with the existing standard of care at the VUMC pain clinic included medication reduction by no more than 20% per visit, which has resulted in higher compliance and reduced withdrawal symptoms.¹⁶ Withdrawal symptoms were assessed with each encounter utilizing the clinical institute narcotic sssessment (CINA) in addition to pain intensity as measured with the numerical rating scale (NRS).^17,18

A purposeful sampling technique was employed to recruit participants from the VUMC pain management clinic in Nashville, TN. The sample size was based on pragmatics of recruiting, patient flow, acupuncturist availability, and budgetary constraints; given this was a feasibility pilot study, a sample size of 16 was established. Informational flyers were provided to chronic pain patients who met inclusion criteria by their treating pain specialist provider. Interested patients (n = 25) were then contacted by the principal investigator (PI) to provide information on the study, address questions or concerns, and obtain informed consent in person. Inclusion criteria were males or females of ages 18–65 years, referred to the pain management clinic for opioid weaning and/or discontinuation, and English speaking. Exclusion criteria included pregnancy or nursing mothers and significant psychologic disease requiring ongoing treatment.

Participants who agreed to be part of the study were randomly assigned into 2 groups as follows: standard of care (n = 7) or standard of care and the addition of NADA protocol (n = 9). The first group received standard outpatient medication management with opioid weaning. This treatment entails monthly follow-up visits with gradual reductions (10%–20% overall MED) in combination with adjuvant nonopioid medications and therapies. Medications utilized for this treatment include antidepressants, muscle relaxants, nonsteroidal anti-inflammatory drug, acetaminophen, anticonvulsants, and α₂ adrenergic agonists. Additional therapies recommended and/or referrals provided often include physical therapy and psychologic support. The second group received the same management but also included acupuncture sessions with each office visit. All patients who underwent acupuncture were assessed for potential adverse events such as skin irritation or vagal response. Upon completion and stabilization of the opioid regimen, each participant received a $25 gift card at the final follow-up appointment.

Intervention

An auricular acupuncture technique was administered on 5 bilateral points of the participants' ear, in accordance with the NADA protocol (Sympathetic, Shen Men, Kidney, Liver, and Lung). The depth of the 25 mm sterile DBC™ spring style acupuncture needle was dependent on the anatomical structure of the participant and position of each acupoint with ∼5 mm; administration was performed without a guide or rotation. In accordance with the NADA protocol, needles remained in place for 35 minutes. Each participant underwent acupuncture once per month until opioid weaning was completed. Completion of the weaning regimen was determined by overall MED (<90 MED) and individual patient functionality as determined by the treating provider. Further reductions in MED were encouraged but are often unattainable depending on each patient's chronic pain symptomatology; therefore, a threshold of 90 MED was established in line with current evidence, indicating risk for respiratory depression and potential overdose above this value.¹⁹ Acupuncture administration was implemented by a NADA-certified and VUMC-credentialed nurse practitioner. Competency of the nurse practitioner was verified with direct observation of clinical technique by a NADA trainer (during the certification process) as well as a collaborative physician trained and certified in medical acupuncture by the Helms Institute. The nurse practitioner had 6 months of experience before initiation of the study and 7 years of chronic pain clinical practice. None of the participants withdrew from the acupuncture group during the study period or before completion, and 1 of the standard of care participants was lost to follow-up.

Randomization and Statistical Methods

All medication management was performed by blinded nurse practitioners and physicians within the pain management clinic. Only the interventionalist (PI) applying acupuncture was aware of participants receiving acupuncture. Patients were further notified not to disclose if they were receiving acupuncture to their provider and procedure notes were maintained in a research electronic data capture (REDCap) system that was password protected.

Participants were randomly assigned to the intervention group or standard of care group with the use of sealed envelopes created by a statistician utilizing a random number of allocation sequence generated by computer software (SPSS 21.0). Continuous variables are described using median (mean ± SD). To assess differences among the 2 groups, a Wilcoxon nonparametric test was performed. A significance level of 0.05 was established for statistical inferences, and R software, version 3.6.0 (www.r-project.org) was used for all statistical analyses.

Results

This study was conducted for a 1-year time period from October 2017 to October 2018 and randomized 16 participants (15 were included in analysis). All of the participants were identified by clinical referral. Participant demographics and baseline characteristics are listed in Table 1. After participants were identified as eligible, they were provided an informational handout outlining study details. If participants remained interested, they were approached by the PI in a private clinic room, provided additional details, and obtained consent (Fig. 1 CONSORT diagram). A total of 25 participants were approached by the PI, 2 did not meet inclusion criteria, and 7 declined to participate as they did not want to return for monthly appointments or did not wish to undergo acupuncture treatments. There were no adverse outcomes such as skin irritation, inflammation, or vagal responses throughout this study.

Table 1.

Demographics

N = 15	N (%)
Race
White	14 (93.3%)
Black	1 (6.7%)
Ethnicity
Hispanic	0
Not Hispanic	15 (100%)
Age	56.5 ± 17.3
Gender—male	8 (53%)

FIG. 1.

CONSORT flow diagram.

Measures

All of the participants provided baseline data at time of consent. Opioid medication regimens were verified and converted to MED. In addition, participants completed a subjective assessment of anxiety and depression (HADS) as well as withdrawal symptoms (CINA) and pain scores (NRS). There were no statistically significant differences among baseline data in comparing participants who received the standard of care (n = 6) with those who underwent acupuncture (n = 9) in addition to routine outpatient opioid weaning (Table 2).

Table 2.

Standard of Care and Acupuncture Participant Outcomes

Measures	Preintervention/baseline			Postintervention
	Median (mean ± SD)			Median (mean ± SD)
	Standard of care	Acupuncture	P	Standard of care	Acupuncture	P
	N = 6	N = 9		N = 6	N = 9
MED	210 (191 ± 121)	68 (112 ± 71)	0.18	94 (125 ± 124)	62 (78 ± 44)	0.43
HADS-D	6.5 (5.8 ± 3.3)	4.0 (5.8 ± 5.0)	0.95	6.6 (7.2 ± 1.3)	4.2 (5.3 ± 4.1)	0.20
HADS-A	6.5 (6.3 ± 3.0)	7.0 (8.5 ± 4.9)	0.46	7.2 (6.6 ± 1.8)	6.3 (7.4 ± 4.2)	0.74
CINA	9.0 (9.7 ± 5.9)	3.5 (5.0 ± 5.7)	0.10	6.7 (7.1 ± 3.8)	5.7 (6.4 ± 3.6)	0.65
NRS	6.5 (6.2 ± 2.2)	5.0 (4.8 ± 1.9)	0.16	7.3 (6.9 ± 1.5)	5.6 (5.2 ± 1.7)	0.07

Wilcoxon nonparametric test was conducted for comparison between groups.

CINA, clinical institute narcotic assessment; HADS-A, hospital anxiety depression scale–anxiety; HADS-D, hospital anxiety depression scale–depression; MED, morphine equivalent dose; NRS, numerical rating scale.

The median baseline MED of participants in the standard of care was 210 MED as compared with 68 MED among those who received acupuncture. There was a higher range of MED among the standard of care group (128–236 MED) than among the acupuncture group (60–158 MED) contributing to the standard of care group's overall median MED being significantly higher; in addition there were no statistically significant differences among these groups (P = 0.18). Preintervention anxiety and depression reports were analyzed separately with mean scores being 6.5 (for both HADS-A and HADS-D in the standard of care group as compared with 7.0 and 4.0, respectively, in the acupuncture group). Median withdrawal scores of the standard of care group were higher (9.0) than of the acupuncture group (3.5) as well as pain scores (6.5 and 5.0, respectively), but none of these were significantly different between groups. After completion of the outpatient opioid weaning program, all measures were reassessed in both groups. The weaning regimen was stopped when the patient and provider felt pain was adequately controlled with an appropriate multimodal regimen and did not result in complete opioid cessation in all cases. Overall, the standard of care group reported higher median MED than the acupuncture group (94 vs. 62), pain scores (7.3 vs. 5.6), symptoms of anxiety (7.2 vs. 6.3), and depression (6.6 vs. 4.2), as well as withdrawal scores (6.7 vs. 5.7); however, none of these were statistically different between groups.

Discussion

The NADA protocol was administered to 9 participants with a history of nonmalignant chronic pain as they underwent outpatient opioid weaning. Overall, all participants were able to successfully reduce opioid medications (MED). Limitations of the study included the small sample size and higher median dose of opioids in the standard of care group than the group receiving acupuncture (no statistical significance). Although patients were randomized in this study, it would be helpful to evaluate a larger sample size to determine whether there would be more drastic reductions in opioid dose in the acupuncture treatment group versus standard of care. Previous animal models reported the NADA protocol decreases opioid-related locomotor sensitization and tolerance,²⁰ raising the question of whether acupuncture is more helpful for weaning high (>90 MED), moderate (40–90 MED), or low (<40 MED) dose opioid regimens. Future studies may consider stratifying patients based on opioid dose to further evaluate this topic of interest. Provider education would likely facilitate the referral process and promote patient awareness of acupuncture as many qualified participants refused to participate out of fear of being stuck by a needle or disbelief acupuncture could provide benefit (n = 7).

Patients considering outpatient opioid tapering programs often report apprehension due to fear of experiencing physiologic symptoms of withdrawal and/or return of chronic pain. Our data suggest auricular acupuncture may serve to improve the psychologic distress of patients undergoing an opioid taper without the use of additional medications. The NADA protocol was especially beneficial in this setting as it was administered within the standard of care and did not require a separate facility, repositioning of the patient, or exposure to multiple body parts. Often, patients with chronic pain are unable to lay flat or maintain certain positions for extended periods of time; utilizing an auricular technique allowed this patient population access to acupuncture treatments.

A meaningful finding was the impact acupuncture appeared to have on symptoms of anxiety, depression, pain, and withdrawal scores as these were lower than the standard of care group. Further therapeutic benefit may be awarded for patients if administered weekly or every 2 weeks, but patients in this study reported opposition in presenting to clinic more frequently, therefore, acupuncture was applied monthly. This is especially impactful given the prevalence of comorbid psychologic conditions in chronic pain patients and reported distress associated with opioid weaning.^21–24 These findings are consistent with other studies utilizing the NADA protocol for detoxification and opioid maintenance treatment, highlighting improved psychologic symptoms of patients.^12,23

In addition, use of the NADA protocol as an adjunct within an opioid detoxification or maintenance program has demonstrated increased treatment retention and lower dosages of opioids in the treatment of opioid use disorder.¹⁴ Such findings may be especially beneficial for outpatient tapering to improve retention and reduce attrition; future studies should assess compliance and completion of the prescribed opioid taper regimen, thus improving patient's quality of life and overall functionality.

Conclusion

Although outcomes were not statistically significant in this study, they support future research and analysis on the use of acupuncture to facilitate outpatient opioid weaning as there was a reduction in overall psychologic distress and pain. Given the prevalence of psychologic conditions and distress among chronic pain patients, utilization of the NADA protocol within the standard of care could further expand treatment options for patients physically dependent on opioids seeking alternative pain management. These findings warrant further investigation on the integration of the NADA protocol within current outpatient weaning programs for patients with chronic nonmalignant pain.

Authors Disclosure Statement

No competing financial interests exist.

Funding Information

This study was funded by the Vanderbilt Institute for Clinical Translational Research (VICTR) Grant for the purchase of participant gift cards.