Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03397212
• Other study ID #: 59065
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 29, 2017
• Last updated: January 5, 2018
• Start date: January 15, 2018
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2018
• Source: Rigshospitalet, Denmark
• Contact: Romanas Polianskis, MD
• Phone: +45 35455233
• Email: romanas.polianskis[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opiate Withdrawal Syndrome
• Substance Withdrawal Syndrome

Intervention

Other:
• NADA acupuncture
Ear acupuncture protocol described by National Acupuncture Detoxification Association
• Sham acupuncture
Ear acupuncture using inactive sham points

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intensity of withdrawal symptoms	Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire	3 months and 1 year
Secondary	Change in quality of life assessed with SF36	Change in quality of life assessed with SF36	3 months and 1 year