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Completed

NCT Number: NCT01512433

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Longtan, Taoyuan, 325, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ture acupuncture

Procedure

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 acupuncture

Procedure

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.

Primary outcomes

  1. opioid craving

    Time frame: four weeks

    opioid craving scores on the Visual Analog Scale

Secondary outcomes

  1. sleep quality

    Time frame: four weeks

    sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

  2. life quality

    Time frame: four weeks

    life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)

Sponsors and collaborators

Lead sponsor

China Medical University, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 19, 2012
Registry last updated
Mar 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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