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Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts (AAMTH)

Primary Purpose

Opiate Withdrawal Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ear acupressure alone
Electroacupuncture plus ear acupressure
Sponsored by
Lu-Tung Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Withdrawal Syndrome focused on measuring methadone, heroin, acupuncture

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for Opioid Use Disorder and had been received methadone maintenance treatment for more then one month.

Exclusion Criteria:

  1. had taking acupuncture treatment in past 30 days
  2. had severe adverse effects or events history from receiving acupuncture treatment
  3. had any serious physical illness
  4. had a significant risk of suicide
  5. ear infection
  6. were pregnant or or a woman plan to pregnant
  7. had bleeding disorders or were taking anticoagulant drugs
  8. had epilepsy, cerebral vascular disease and brain injured history.

Sites / Locations

  • Lu-Tung Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ear acupressure & Electroacupuncture (A)

Ear acupressure & Electroacupuncture (B)

Arm Description

Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.

Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.

Outcomes

Primary Outcome Measures

Assessed the change of opioid craving
opioid craving scores on the Visual Analog Scale

Secondary Outcome Measures

Assessed the change of life quality
Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)
Assessed the change of emotion problem
Emotion problems was evaluated by Beck anxiety and Depression inventory
Opiate usage
Use urine test to detect opiate use
Assessed the change of sleep quality
Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

Full Information

First Posted
October 29, 2016
Last Updated
December 4, 2017
Sponsor
Lu-Tung Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03012373
Brief Title
Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
Acronym
AAMTH
Official Title
Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
May 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lu-Tung Christian Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for heroin addicts.
Detailed Description
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 heroin addiction patients are needed. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to compare the difference of efficacy between ear acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with standard methadone maintenance therapy to the heroin addicts. Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20) receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week wash-out period. Then ear acupressure alone for another four weeks. Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week wash-out period, then ear acupressure combined with electroacupuncture for another four weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of treatment, to screen opiate reuse. The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Withdrawal Syndrome
Keywords
methadone, heroin, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ear acupressure & Electroacupuncture (A)
Arm Type
Experimental
Arm Description
Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.
Arm Title
Ear acupressure & Electroacupuncture (B)
Arm Type
Experimental
Arm Description
Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.
Intervention Type
Procedure
Intervention Name(s)
Ear acupressure alone
Other Intervention Name(s)
Auricular acupressure
Intervention Description
The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes then were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture plus ear acupressure
Other Intervention Name(s)
Electric acupuncture
Intervention Description
Acupuncture included Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation was conducted. The frequency of electrical stimulation was 5 Hz and wave form was adjustable. The intensities of the stimulation were increased in 1 mA increments to maximal tolerable intensity. At the same time, The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes. After 15 minutes treatment, acupuncture needles were removed and magnet pellets were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
Primary Outcome Measure Information:
Title
Assessed the change of opioid craving
Description
opioid craving scores on the Visual Analog Scale
Time Frame
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary Outcome Measure Information:
Title
Assessed the change of life quality
Description
Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)
Time Frame
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Title
Assessed the change of emotion problem
Description
Emotion problems was evaluated by Beck anxiety and Depression inventory
Time Frame
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Title
Opiate usage
Description
Use urine test to detect opiate use
Time Frame
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Title
Assessed the change of sleep quality
Description
Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Time Frame
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for Opioid Use Disorder and had been received methadone maintenance treatment for more then one month. Exclusion Criteria: had taking acupuncture treatment in past 30 days had severe adverse effects or events history from receiving acupuncture treatment had any serious physical illness had a significant risk of suicide ear infection were pregnant or or a woman plan to pregnant had bleeding disorders or were taking anticoagulant drugs had epilepsy, cerebral vascular disease and brain injured history.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chen Ouyang, Ph.D.
Organizational Affiliation
Lu-Tung Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lu-Tung Christian Hospital
City
Changhua
ZIP/Postal Code
505
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24871652
Citation
Chan YY, Lo WY, Li TC, Shen LJ, Yang SN, Chen YH, Lin JG. Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. Am J Chin Med. 2014;42(3):569-86. doi: 10.1142/S0192415X14500372.
Results Reference
background
PubMed Identifier
22474521
Citation
Lin JG, Chan YY, Chen YH. Acupuncture for the treatment of opiate addiction. Evid Based Complement Alternat Med. 2012;2012:739045. doi: 10.1155/2012/739045. Epub 2012 Feb 22.
Results Reference
background
PubMed Identifier
25530779
Citation
Boyuan Z, Yang C, Ke C, Xueyong S, Sheng L. Efficacy of acupuncture for psychological symptoms associated with opioid addiction: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:313549. doi: 10.1155/2014/313549. Epub 2014 Nov 4.
Results Reference
background
Links:
URL
http://store.samhsa.gov/product/TIP-45-Detoxification-and-Substance-Abuse-Treatment/SMA15-4131
Description
Detoxification and Substance Abuse Treatment.

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Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts

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