Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

January 5, 2018 updated by: Romanas Polianskis, Rigshospitalet, Denmark

Assessment of NADA Acupuncture for Treatment of Withdrawal Symptoms During Gradual Opioid Withdrawal in Chronic Pain Patients

This project aims at examining the following hypotheses:

  • Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine.
  • Opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic pain patients treated with opioids over 3 months
  • The patient's doctor or nurse assesses that there is an indication to opioid withdrawal and / or the patient wishes to withdraw.
  • The patient is motivated for opioid withdrawal
  • The patient has experienced withdrawal symptoms
  • The patient must be able to understand, speak and write Danish
  • The patient must be able to transport himself to the pain center

Exclusion Criteria:

  • Children under 18 years old
  • External ear infection
  • Treatment with benzodiazepines.
  • Active substance abuse and alcohol abuse.
  • Contraindications for treatment with clonidine:
  • Allergy
  • Bradyarrhythmias caused by diseased sinus cube or AV block of 2nd or 3rd grade.
  • lactose intolerance
  • Heart failure
  • High medullary damage
  • Cardiac conduction disturbances
  • Pregnancy and breastfeeding

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NADA and Clonidine
NADA acupuncture and treatment with tbl Clonidine
Other: NADA acupuncture
Ear acupuncture protocol described by National Acupuncture Detoxification Association
Sham Comparator: Sham acupuncture and Clonidine
Sham ear acupuncture and treatment with tbl Clonidine
Other: Sham acupuncture
Ear acupuncture using inactive sham points

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intensity of withdrawal symptoms
Time Frame: 3 months and 1 year
Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire
3 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life assessed with SF36
Time Frame: 3 months and 1 year
Change in quality of life assessed with SF36
3 months and 1 year

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

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 (Anticipated)

January 15, 2018

Primary Completion (Anticipated)

January 15, 2022

Study Completion (Anticipated)

January 15, 2024

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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