Back to resultsTreatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients
Primary Purpose
Chronic Pain, Opiate Withdrawal Syndrome
Status
Not yet recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
NADA acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring NADA
Eligibility 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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
NADA and Clonidine
Sham acupuncture and Clonidine
Arm Description
NADA acupuncture and treatment with tbl Clonidine
Sham ear acupuncture and treatment with tbl Clonidine
Outcomes
Primary Outcome Measures
Change in intensity of withdrawal symptoms
Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire
Secondary Outcome Measures
Change in quality of life assessed with SF36
Change in quality of life assessed with SF36
Full Information
NCT ID
NCT03397212
First Posted
November 29, 2017
Last Updated
January 5, 2018
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03397212
Brief Title
Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients
Official Title
Assessment of NADA Acupuncture for Treatment of Withdrawal Symptoms During Gradual Opioid Withdrawal in Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2018 (Anticipated)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opiate Withdrawal Syndrome
Keywords
NADA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NADA and Clonidine
Arm Type
Experimental
Arm Description
NADA acupuncture and treatment with tbl Clonidine
Arm Title
Sham acupuncture and Clonidine
Arm Type
Sham Comparator
Arm Description
Sham ear acupuncture and treatment with tbl Clonidine
Intervention Type
Other
Intervention Name(s)
NADA acupuncture
Intervention Description
Ear acupuncture protocol described by National Acupuncture Detoxification Association
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
Ear acupuncture using inactive sham points
Primary Outcome Measure Information:
Title
Change in intensity of withdrawal symptoms
Description
Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire
Time Frame
3 months and 1 year
Secondary Outcome Measure Information:
Title
Change in quality of life assessed with SF36
Description
Change in quality of life assessed with SF36
Time Frame
3 months and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romanas Polianskis, MD
Phone
+45 35455233
Email
romanas.polianskis@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jette Højsted, MD
Phone
+45 35457383
Email
jette.hoejsted@regionh.dk
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients
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