Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

Narcotic Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02882048
• Other study ID #: 160725
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 25, 2019

Study information

• Verified date: March 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 25, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 and older

• Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.

Exclusion Criteria:

Related Conditions & MeSH terms

• Behavior, Addictive
• Narcotic Addiction
• Opioid-Related Disorders

Intervention

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

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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