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

The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Opiate Dependence
• Intervention / Treatment: Procedure: Ture acupuncture; Procedure: Sham acupuncture

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Longtan, Taoyuan, Taiwan, 325
      • Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: True acupuncture; True acupuncture was a real acupuncture which had been used in conventional Chinese medicine practice	Procedure: Ture acupuncture; Ture acupuncture included shenmen point in the ear cartilage ridge area without electrical stimulation and Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation. The frequency of stimulation alternated between 20 and 100 Hz (dense and disperse, DD) at automatic 2-second intervals. The intensities of the stimulations were increased in 1 mA increments to maximal tolerable intensity.
Sham Comparator: Sham acupuncture; Sham acupuncture was a procedure which mimicked the real acupuncture procedure.	Procedure: Sham acupuncture; The needles on the bilateral Hegu (LI 4) and Zusanli (ST 36) were then connected to the electro-acupuncture machine with zero frequencies and amplitude."DeQi"was avoided during needling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid craving	opioid craving scores on the Visual Analog Scale	four weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China Medical University, Taiwan

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): March 25, 2013
• Last Update Submitted That Met QC Criteria: March 21, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: acupuncture; methadone
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: NSC 100-2320-B-039-029-MY2