Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

NCT03397212 | Unknown Phase 4 DMC

• 1 other identifier: 59065
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Opiate Withdrawal Syndrome

Keywords

NADA

Outcome Measures

Primary Outcomes (1)

• Change in intensity of withdrawal symptoms

  Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire

  3 months and 1 year

Secondary Outcomes (1)

• Change in quality of life assessed with SF36

  3 months and 1 year

Study Arms (2)

NADA and Clonidine

EXPERIMENTAL

NADA acupuncture and treatment with tbl Clonidine

Other: NADA acupuncture

Sham acupuncture and Clonidine

SHAM COMPARATOR

Sham ear acupuncture and treatment with tbl Clonidine

Other: Sham acupuncture

Interventions

NADA acupuncture OTHER

Ear acupuncture protocol described by National Acupuncture Detoxification Association

NADA and Clonidine

Sham acupuncture OTHER

Ear acupuncture using inactive sham points

Sham acupuncture and Clonidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Romanas Polianskis, MD

CONTACT

+45 35455233; romanas.polianskis@regionh.dk

Jette Højsted, MD

CONTACT

+45 35457383; jette.hoejsted@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: January 11, 2018
• Study Start: January 15, 2018
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2024
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)