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Efficacy of Electro-Acupuncture Therapy for Patients With Methadone Maintenance Treatment

Primary Purpose

Sleep Disorder (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electroacupuncture+auricular pressure,
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder (Disorder)

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Comply with Diagnostic Guidelines for Mental Disorders (DSM-V) for diagnosis of opioid use disorders
  • Rules accepting Methadone Maintenance Therapy
  • Patients between the ages of 20 and 65.

Exclusion Criteria:

  • Unacceptable for research content.
  • The detector cannot be completed.
  • Unwilling to cooperate with acupuncture and ear beans.
  • Those whose vital signs are unstable.

Sites / Locations

  • Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, TaiwanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

electroacupuncture+auricular pressure

auricular pressure

Arm Description

a group :electroacupuncture+auricular pressure for 20 minutes twice a week for 4 weeks

b group :auricular pressure for 20 minutes twice a week for 4 weeks.

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Index
The highest score in the whole questionnaire is 21 point, and the lowest score is 0 points.The lower the score, the better the sleep quality
Severity of Dependence Scale
The highest score in the whole questionnaire is 15 point, and the lowest score is 0 points. The higher the score, the worse of the severity of dependence.
Visual analogue scale
The highest score in the whole questionnaire is 10 point, and the lowest score is 0 points. The higher the score, the more serious of the pain.
Clinical Opiate Withdrawal Scale
The highest score in the whole questionnaire is 55 point, and the lowest score is 0 points. The higher the score, the more serious of the Withdrawal symptom.
Beck Depression Inventory
The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points. The higher the score, the more serious of depression.
Beck Anxiety Inventory
The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points. The higher the score, the more serious of anxiety.
The Short Form (36) Health Survey
The highest score in the whole questionnaire is 100 point, and the lowest score is 0 points. The lower the score, the better quality of life.
Craving Scale
The highest score in the whole questionnaire is 108 point, and the lowest score is 0 points. The higher the score, the more serious of craving behavior.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2018
Last Updated
March 16, 2019
Sponsor
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03881618
Brief Title
Efficacy of Electro-Acupuncture Therapy for Patients With Methadone Maintenance Treatment
Official Title
the Efficacy of Electro-acupuncture Therapy for Patients With Methadone Maintenance Treatment : a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The population of drug abuse(heroin) had reached about 200,000 in Taiwan, and the age distribution is mainly in young adults. The social, medical and economic problems of drug addiction are profound and include lost productivity, disrupted relationships, crime and violence, HIV/AIDS and other infectious diseases. Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. This research is aim to build a development model. First of all, investigators plan to review some convincing articles and then analyze the efficacy of TCM in drug addiction. According to review articles and experience of professionals, investigators establish a model for TCM included in addiction treatment. Investigators will cooperate with Western medicine together , through common assessment scales to confirm the efficacy of traditional Chinese medicine and compare with current routine treatment.
Detailed Description
Drug addiction is a chronic medical illness and an important public health problem worldwide. The population of drug abuse had reached about 200,000 in Taiwan, and the age distribution is mainly in young adults. The social, medical and economic problems of drug addiction are profound and include lost productivity, disrupted relationships, crime and violence, HIV/AIDS and other infectious diseases. Therefore, drug addiction treatment is a hot issue of Ministry of Health and Welfare . Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. Therefore, adjuvant therapeutic interventions for drug addiction patients are needed. Contrast to conventional Western medicine, traditional Chinese medicine is the most common used therapy of complementary and alternative medicine. However, traditional Chinese medicine (TCM) was excluded from the service for drug addiction treatment. Investigators need to establish a model for TCM as an alternative therapy included in addiction treatment and provide a better care system for drug addiction. This research is aim to build a development model. First of all, investigators plan to review some convincing articles and then analyze the efficacy of TCM in drug addiction. According to review articles and experience of professionals, we establish a model for TCM included in addiction treatment. Investigators will cooperate with Western medicine together , through common assessment scales to confirm the efficacy of traditional Chinese medicine and compare with current routine treatment. According to above experience, investigators provide a Standard Operation Procedure for TCM treatment for drug addiction and policy suggestion. For drug addiction , this factually achieves communication and integration of Chinese and Western medicine, and benefits the public.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
two group . a group and b group. the intervention of a group is electroacupuncture + auricular pressure and b group is auricular pressure ,after intervention for 1 month and crossover.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture+auricular pressure
Arm Type
Experimental
Arm Description
a group :electroacupuncture+auricular pressure for 20 minutes twice a week for 4 weeks
Arm Title
auricular pressure
Arm Type
Active Comparator
Arm Description
b group :auricular pressure for 20 minutes twice a week for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
electroacupuncture+auricular pressure,
Other Intervention Name(s)
auricular pressure
Intervention Description
electroacupuncture+auricular pressure for 20 minutes
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
The highest score in the whole questionnaire is 21 point, and the lowest score is 0 points.The lower the score, the better the sleep quality
Time Frame
20 months
Title
Severity of Dependence Scale
Description
The highest score in the whole questionnaire is 15 point, and the lowest score is 0 points. The higher the score, the worse of the severity of dependence.
Time Frame
20 months
Title
Visual analogue scale
Description
The highest score in the whole questionnaire is 10 point, and the lowest score is 0 points. The higher the score, the more serious of the pain.
Time Frame
20 months
Title
Clinical Opiate Withdrawal Scale
Description
The highest score in the whole questionnaire is 55 point, and the lowest score is 0 points. The higher the score, the more serious of the Withdrawal symptom.
Time Frame
20 months
Title
Beck Depression Inventory
Description
The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points. The higher the score, the more serious of depression.
Time Frame
20 months
Title
Beck Anxiety Inventory
Description
The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points. The higher the score, the more serious of anxiety.
Time Frame
20 months
Title
The Short Form (36) Health Survey
Description
The highest score in the whole questionnaire is 100 point, and the lowest score is 0 points. The lower the score, the better quality of life.
Time Frame
20 months
Title
Craving Scale
Description
The highest score in the whole questionnaire is 108 point, and the lowest score is 0 points. The higher the score, the more serious of craving behavior.
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Comply with Diagnostic Guidelines for Mental Disorders (DSM-V) for diagnosis of opioid use disorders Rules accepting Methadone Maintenance Therapy Patients between the ages of 20 and 65. Exclusion Criteria: Unacceptable for research content. The detector cannot be completed. Unwilling to cooperate with acupuncture and ear beans. Those whose vital signs are unstable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Kai-Chiang
Phone
8860978157553
Email
dau70@tpech.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YU Kai-Chiang
Organizational Affiliation
Chinese Medicine Center Medical Office
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan
City
Taipei county
State/Province
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yu Kai-Chiang
Phone
8860978157553
Email
dau70@tpech.gov.tw

12. IPD Sharing Statement

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Efficacy of Electro-Acupuncture Therapy for Patients With Methadone Maintenance Treatment

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