Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

Study Overview
=================
Brief Summary
-----------------
This study is to compare two groups undergoing opioid weaning as ordered by their referring physicians. One group will undergo the standard opioid weaning process and the other group will have the addition of the NADA Protocol to the weaning process.

Detailed Description
-----------------
The NADA (National Acupuncture Detoxification Association) Protocol is a standardized acupuncture technique in which five designated points in the ear are needled (+/-beads/seeds at points for home acupressure therapy in between treatments). The NADA Protocol is indicated for treatment of the following conditions: detoxification, withdrawal, emotional trauma, craving, stress syndromes, relapse prevention, rehabilitation & recovery maintenance. It is also commonly used for PTSD and addiction; however it has not been studied as an adjunct to outpatient opioid weaning protocols for pain. It is cited in the literature as yielding improvements in engagement, retention, decreased cravings, anxiety, and physical symptoms. Given these documented results, it seems feasible the outpatient opioid weaning patient would likely benefit from this procedure.

Official Title
-----------------
A Randomized Controlled Trial of Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

Conditions
-----------------
Narcotic Addiction

Intervention / Treatment
-----------------
* Procedure: NADA Protocol
* Other: Medication management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 and older Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication management & NADA Protocol<br>Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly | Procedure: NADA Protocol<br>* NADA Protocol is a standardized acupuncture technique in which five designated points in the ear are needled.<br>* Other names: National Acupuncture Detoxification Association Protocol;Other: Medication management<br>* Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens.<br>|
| Active Comparator: Medication management<br>Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens. | Other: Medication management<br>* Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal |  | time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off-opioids rate |  | time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months) | 
| Change from baseline assessment of psychological distress of weaning, assessed using the Hospital Anxiety and Depression Scale (HADS) |  | 9 months | 
| Time to cessation of opioids |  | time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid addiction, Opioid weaning