Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

Not Applicable

Terminated

• Conditions: Narcotic Addiction
• Interventions: Other: Medication management; Procedure: NADA Protocol

• Registration Number: NCT02882048
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-29
• Study Start: 2016-09
• Primary Completion: 2019-01-14
• Study Completion: 2019-02-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Adults aged 18 and older
• Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication management	Medication management	Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens.
Medication management & NADA Protocol	NADA Protocol	Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly
Medication management & NADA Protocol	Medication management	Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to cessation of opioids	time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months)
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States