NCT02882048

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

2.4 years

First QC Date

August 24, 2016

Last Update Submit

March 28, 2019

Conditions

Narcotic Addiction

Keywords

Opioid addictionOpioid weaning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

Study Arms (2)

Medication management & NADA Protocol

EXPERIMENTAL

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

Procedure: NADA ProtocolOther: Medication management

Medication management

ACTIVE COMPARATOR

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

Other: Medication management

Interventions

NADA ProtocolPROCEDURE

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

Also known as: National Acupuncture Detoxification Association Protocol
Medication management & NADA Protocol
Medication managementOTHER

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

Medication managementMedication management & NADA Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

  • 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.

    PMID: 33912273DERIVED

MeSH Terms

Conditions

Narcotic-Related DisordersOpioid-Related Disorders

Interventions

Medication Therapy Management

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMedicare Part DInsurance, Pharmaceutical ServicesInsurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsMedicarePatient Care ManagementHealth Services Administration

Study Officials

  • Heather Jackson, MSN, APRN-BC

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant in Anesthesiology

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

September 1, 2016

Primary Completion

January 14, 2019

Study Completion

February 25, 2019

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)