Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

Rigshospitalet

Status and phase: Unknown; Phase 4

Conditions: Opiate Withdrawal Syndrome; Chronic Pain

Treatments: Other: Sham acupuncture; Other: NADA acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03397212

59065

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

NADA and Clonidine

Experimental group

Description:

NADA acupuncture and treatment with tbl Clonidine

Treatment:

Other: NADA acupuncture

Sham acupuncture and Clonidine

Sham Comparator group

Description:

Sham ear acupuncture and treatment with tbl Clonidine

Treatment:

Other: Sham acupuncture