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

Not Applicable

Completed

• Conditions: Opiate Dependence
• Interventions: Procedure: Ture acupuncture; Procedure: Sham acupuncture

• Registration Number: NCT01512433
• Lead Sponsor: China Medical University, Taiwan

Brief Summary

The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy to the heroin addicts.

Detailed Description

Methadone maintenance therapy for the treatment of heroin addicts for more than 40 years , and there are many studies confirm its effectiveness, such as reduced heroin addiction, reduced high-risk needle use, reduced criminal activity. But methadone also had side effects such as drowsiness, constipation, insomnia, nausea, vomiting, sweating and respiratory depression.Then the long-term heroin addicts may irregular to take methadone, which increase the risk of reuse heroin or other drugs. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy to the heroin addicts.

The study will be consisted of 60 heroin addicts and the inclusion criteria were: (1) age more then 20 years; (2) fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence and had been received methadone maintenance treatment for more then one month. Subjects were excluded if they: (1) concurrent treatment with antidepressant or neuroleptic medication; (2) had taking acupuncture treatment in past 30 days; (3) had severe adverse effects or events history from receiving acupuncture treatment; (4) had any serious physical illness; (5) had a significant risk of suicide; (6) ear infection; (7) were pregnant or or a woman plan to pregnant; (8) had bleeding disorders or were taking anticoagulant drugs; (9) Human Immunodeficiency Virus (HIV) positive; (10) had epilepsy, cerebral vascular disease and brain injured history.The study used a randomized, placebo-controlled study design. Patients were randomly assigned to receive methadone with verum acupuncture condition (n = 30), methadone with sham acupuncture condition (n = 30). Treatments were offered 2 times weekly for 4 weeks. Weekly measures of methadone dosage and using the visual analog scale (VAS) to assess the craving severity for 4 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to provide an assessment of quality of life and sleep quality over the previous 4 weeks.

The study hypothesis was acupuncture had clinical efficacy upon craving severity, life quality, reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Primary Completion: 2012-03
• Study Completion: 2013-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence and had been received methadone maintenance treatment for more then one month.

Exclusion Criteria

• concurrent treatment with antidepressant or neuroleptic medication
• 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
• Human Immunodeficiency Virus (HIV) positive
• had epilepsy, cerebral vascular disease and brain injured history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
True acupuncture	Ture acupuncture	True acupuncture was a real acupuncture which had been used in conventional Chinese medicine practice
Sham acupuncture	Sham acupuncture	Sham acupuncture was a procedure which mimicked the real acupuncture procedure.

Primary Outcome Measures

Name	Time	Method
opioid craving	four weeks	opioid craving scores on the Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
sleep quality	four weeks	sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
life quality	four weeks	life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)

Trial Locations

Locations (1)

Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan.; 🇨🇳 Longtan, Taoyuan, Taiwan