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

December 4, 2017 updated by: Wen-Chen Ouyang, Lu-Tung Christian Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan, 505
        • Lu-Tung Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ear acupressure & Electroacupuncture (A)
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.
Procedure: Ear acupressure alone
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.
Other Names:
  • Auricular acupressure
Procedure: Electroacupuncture plus ear acupressure
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.
Other Names:
  • Electric acupuncture
Experimental: Ear acupressure & Electroacupuncture (B)
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.
Procedure: Ear acupressure alone
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.
Other Names:
  • Auricular acupressure
Procedure: Electroacupuncture plus ear acupressure
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.
Other Names:
  • Electric acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessed the change of opioid craving
Time Frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
opioid craving scores on the Visual Analog Scale
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessed the change of life quality
Time Frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of emotion problem
Time Frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Emotion problems was evaluated by Beck anxiety and Depression inventory
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Opiate usage
Time Frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Use urine test to detect opiate use
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of sleep quality
Time Frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lu-Tung Christian Hospital

Investigators

  • Principal Investigator: Wen-Chen Ouyang, Ph.D., Lu-Tung Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

March 30, 2018

Study Completion (Anticipated)

May 30, 2018

Study Registration Dates

First Submitted

October 29, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LuTungCH-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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