Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02882048

Collaborator

(none)

Enrollment

Location

Arms

29.8

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Narcotic Addiction	Procedure: NADA Protocol Other: Medication management	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jan 14, 2019

Actual Study Completion Date :

Feb 25, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Medication management & NADA Protocol

Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly

Procedure: NADA Protocol

NADA Protocol is a standardized acupuncture technique in which five designated points in the ear are needled.

Other Names:

National Acupuncture Detoxification Association Protocol

Other: Medication management

Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens.

Active Comparator: Medication management

Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens.

Other: Medication management

Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

Principal Investigator: Heather Jackson, MSN, APRN-BC, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heather Jackson, Assistant in Anesthesiology, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT02882048

Other Study ID Numbers:

160725

First Posted:

Aug 29, 2016

Last Update Posted:

Apr 1, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Heather Jackson, Assistant in Anesthesiology, Vanderbilt University Medical Center

Opioid addiction

Opioid weaning

Additional relevant MeSH terms:

Narcotic-Related Disorders

Behavior, Addictive

Study Results

No Results Posted as of Apr 1, 2019