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Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

Primary Purpose

Narcotic Addiction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NADA Protocol
Medication management
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcotic Addiction focused on measuring Opioid addiction, Opioid weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medication management & NADA Protocol

Medication management

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal

Secondary Outcome Measures

Off-opioids rate
Change from baseline assessment of psychological distress of weaning, assessed using the Hospital Anxiety and Depression Scale (HADS)
Time to cessation of opioids

Full Information

First Posted
August 24, 2016
Last Updated
March 28, 2019
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02882048
Brief Title
Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
Official Title
A Randomized Controlled Trial of Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
September 2016 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcotic Addiction
Keywords
Opioid addiction, Opioid weaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication management & NADA Protocol
Arm Type
Experimental
Arm Description
Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly
Arm Title
Medication management
Arm Type
Active Comparator
Arm Description
Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens.
Intervention Type
Procedure
Intervention Name(s)
NADA Protocol
Other Intervention Name(s)
National Acupuncture Detoxification Association Protocol
Intervention Description
NADA Protocol is a standardized acupuncture technique in which five designated points in the ear are needled.
Intervention Type
Other
Intervention Name(s)
Medication management
Intervention Description
Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Off-opioids rate
Time Frame
time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)
Title
Change from baseline assessment of psychological distress of weaning, assessed using the Hospital Anxiety and Depression Scale (HADS)
Time Frame
9 months
Title
Time to cessation of opioids
Time Frame
time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 and older Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Jackson, MSN, APRN-BC
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33912273
Citation
Jackson HJ, Walters J, Raman R. Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study. Med Acupunct. 2021 Apr 1;33(2):153-158. doi: 10.1089/acu.2020.1450. Epub 2021 Apr 19.
Results Reference
derived

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Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

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