Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

Phase 4

• Conditions: Opiate Withdrawal Syndrome; Chronic Pain
• Interventions: Other: Sham acupuncture; Other: NADA acupuncture

• Registration Number: NCT03397212
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-29
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-05
• Last Update Submitted: 2018-01-05
• Study First Posted: 2018-01-11
• Last Update Posted: 2018-01-11
• Study Start: 2018-01-15
• Primary Completion: 2022-01-15
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham acupuncture and Clonidine	Sham acupuncture	Sham ear acupuncture and treatment with tbl Clonidine
NADA and Clonidine	NADA acupuncture	NADA acupuncture and treatment with tbl Clonidine

Primary Outcome Measures

Name	Time	Method
Change in intensity of withdrawal symptoms	3 months and 1 year	Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in quality of life assessed with SF36	3 months and 1 year	Change in quality of life assessed with SF36

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark