Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

NCT ID: NCT03397212

Last Updated: 2018-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2024-01-15

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.

Detailed Description

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Conditions

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Chronic Pain Opiate Withdrawal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NADA and Clonidine

NADA acupuncture and treatment with tbl Clonidine

Group Type EXPERIMENTAL

NADA acupuncture

Intervention Type OTHER

Ear acupuncture protocol described by National Acupuncture Detoxification Association

Sham acupuncture and Clonidine

Sham ear acupuncture and treatment with tbl Clonidine

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type OTHER

Ear acupuncture using inactive sham points

Interventions

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NADA acupuncture

Ear acupuncture protocol described by National Acupuncture Detoxification Association

Intervention Type OTHER

Sham acupuncture

Ear acupuncture using inactive sham points

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Romanas Polianskis

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Romanas Polianskis, MD

Role: CONTACT

+45 35455233

Jette Højsted, MD

Role: CONTACT

+45 35457383

Other Identifiers

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59065

Identifier Type: -

Identifier Source: org_study_id

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