Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain, Opiate Withdrawal Syndrome

Intervention / Treatment
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* Other: NADA acupuncture
* Other: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intensity of withdrawal symptoms | 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 | Change in quality of life assessed with SF36 | 3 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NADA