The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 25, 2013
March 1, 2013
7 months
January 10, 2012
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
opioid craving
opioid craving scores on the Visual Analog Scale
four weeks
Secondary Outcomes (2)
sleep quality
four weeks
life quality
four weeks
Study Arms (2)
True acupuncture
ACTIVE COMPARATORTrue acupuncture was a real acupuncture which had been used in conventional Chinese medicine practice
Sham acupuncture
SHAM COMPARATORSham acupuncture was a procedure which mimicked the real acupuncture procedure.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan.
Longtan, Taoyuan, 325, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 19, 2012
Study Start
August 1, 2011
Primary Completion
March 1, 2012
Study Completion
January 1, 2013
Last Updated
March 25, 2013
Record last verified: 2013-03