Treatment of Withdrawal Symptoms With NADA Acupuncture in... | NCT03397212

Studies
Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

NCT03397212

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Jan 11, 2018Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Chronic Pain
Opiate Withdrawal Syndrome

Interventions

NADA acupuncture
Sham acupuncture

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Estimated

Primary Completion Date

Jan 15, 2022Estimated

Completion Date

Jan 15, 2024Estimated

First Submitted Date

Nov 29, 2017

First Submission Date that Met QC Criteria

Jan 5, 2018

First Posted Date

Jan 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NADA and Clonidine	Experimental	NADA acupuncture and treatment with tbl Clonidine	Other: NADA acupuncture
Sham acupuncture and Clonidine	Sham Comparator	Sham ear acupuncture and treatment with tbl Clonidine	Other: Sham acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NADA acupuncture	Other	Ear acupuncture protocol described by National Acupuncture Detoxification Association	NADA and Clonidine

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Romanas Polianskis, MD	Contact	+45 35455233		romanas.polianskis@regionh.dk
Jette Højsted, MD	Contact	+45 35457383		jette.hoejsted@regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided