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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuan-Yu Chan, China Medical University, Taiwan
ClinicalTrials.gov Identifier:
NCT01512433
First received: January 10, 2012
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Opiate Dependence
Procedure: Ture acupuncture
Procedure: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by China Medical University, Taiwan:

Primary Outcome Measures:
  • opioid craving [ Time Frame: four weeks ] [ Designated as safety issue: No ]
    opioid craving scores on the Visual Analog Scale


Secondary Outcome Measures:
  • sleep quality [ Time Frame: four weeks ] [ Designated as safety issue: No ]
    sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

  • life quality [ Time Frame: four weeks ] [ Designated as safety issue: No ]
    life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)


Enrollment: 60
Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512433

Locations
Taiwan
Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan.
Longtan, Taoyuan, Taiwan, 325
Sponsors and Collaborators
China Medical University, Taiwan
  More Information

No publications provided

Responsible Party: Yuan-Yu Chan, Principal Investigator, China Medical University, Taiwan
ClinicalTrials.gov Identifier: NCT01512433     History of Changes
Other Study ID Numbers: NSC 100-2320-B-039-029-MY2
Study First Received: January 10, 2012
Last Updated: March 21, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by China Medical University, Taiwan:
acupuncture
methadone

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014