The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
Primary Purpose
Opiate Dependence
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ture acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring acupuncture, methadone
Eligibility 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.
Sites / Locations
- Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
True acupuncture
Sham acupuncture
Arm Description
True acupuncture was a real acupuncture which had been used in conventional Chinese medicine practice
Sham acupuncture was a procedure which mimicked the real acupuncture procedure.
Outcomes
Primary Outcome Measures
opioid craving
opioid craving scores on the Visual Analog Scale
Secondary Outcome Measures
sleep quality
sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
life quality
life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)
Full Information
NCT ID
NCT01512433
First Posted
January 10, 2012
Last Updated
March 21, 2013
Sponsor
China Medical University, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01512433
Brief Title
The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
Official Title
The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
acupuncture, methadone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
True acupuncture
Arm Type
Active Comparator
Arm Description
True acupuncture was a real acupuncture which had been used in conventional Chinese medicine practice
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
Sham acupuncture was a procedure which mimicked the real acupuncture procedure.
Intervention Type
Procedure
Intervention Name(s)
Ture acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham acupuncture
Intervention Description
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 Outcome Measure Information:
Title
opioid craving
Description
opioid craving scores on the Visual Analog Scale
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
sleep quality
Description
sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Time Frame
four weeks
Title
life quality
Description
life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)
Time Frame
four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan.
City
Longtan
State/Province
Taoyuan
ZIP/Postal Code
325
Country
Taiwan
12. IPD Sharing Statement
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The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
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