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

Study Overview
=================
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.

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

Conditions
-----------------
Opiate Withdrawal Syndrome

Intervention / Treatment
-----------------
* Procedure: Ear acupressure alone
* Procedure: Electroacupuncture plus ear acupressure


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ear acupressure & Electroacupuncture (A)<br>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<br>* 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.<br>* Other names: Auricular acupressure;Procedure: Electroacupuncture plus ear acupressure<br>* 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.<br>* Other names: Electric acupuncture;|
| Experimental: Ear acupressure & Electroacupuncture (B)<br>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<br>* 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.<br>* Other names: Auricular acupressure;Procedure: Electroacupuncture plus ear acupressure<br>* 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.<br>* Other names: Electric acupuncture;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessed the change of opioid craving | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methadone, heroin, acupuncture