Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

March 28, 2019 updated by: Heather Jackson, Vanderbilt University Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Off-opioids rate
Time Frame: time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)
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)
Time Frame: 9 months
9 months
Time to cessation of opioids
Time Frame: time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months)
time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

January 14, 2019

Study Completion (Actual)

February 25, 2019

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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