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Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

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ClinicalTrials.gov Identifier: NCT03397212
Recruitment Status : Not yet recruiting
First Posted : January 11, 2018
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Romanas Polianskis, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Opiate Withdrawal Syndrome Other: NADA acupuncture Other: Sham acupuncture Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of NADA Acupuncture for Treatment of Withdrawal Symptoms During Gradual Opioid Withdrawal in Chronic Pain Patients
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Clonidine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NADA and Clonidine
NADA acupuncture and treatment with tbl Clonidine
Other: NADA acupuncture
Ear acupuncture protocol described by National Acupuncture Detoxification Association
Sham Comparator: Sham acupuncture and Clonidine
Sham ear acupuncture and treatment with tbl Clonidine
Other: Sham acupuncture
Ear acupuncture using inactive sham points



Primary Outcome Measures :
  1. Change in intensity of withdrawal symptoms [ Time Frame: 3 months and 1 year ]
    Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire


Secondary Outcome Measures :
  1. Change in quality of life assessed with SF36 [ Time Frame: 3 months and 1 year ]
    Change in quality of life assessed with SF36



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397212


Contacts
Contact: Romanas Polianskis, MD +45 35455233 romanas.polianskis@regionh.dk
Contact: Jette Højsted, MD +45 35457383 jette.hoejsted@regionh.dk

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

Responsible Party: Romanas Polianskis, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03397212     History of Changes
Other Study ID Numbers: 59065
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Romanas Polianskis, Rigshospitalet, Denmark:
NADA

Additional relevant MeSH terms:
Chronic Pain
Substance Withdrawal Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action