Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
AAMTH
1 other identifier
interventional
40
1 country
1
Brief Summary
This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for 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 Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 29, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedDecember 5, 2017
December 1, 2017
1.8 years
October 29, 2016
December 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessed the change of opioid craving
opioid craving scores on the Visual Analog Scale
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Secondary Outcomes (4)
Assessed the change of life quality
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of emotion problem
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Opiate usage
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Assessed the change of sleep quality
Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
Study Arms (2)
Ear acupressure & Electroacupuncture (A)
EXPERIMENTALElectroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.
Ear acupressure & Electroacupuncture (B)
EXPERIMENTALElectroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.
Interventions
The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes then were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
Acupuncture included Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation was conducted. The frequency of electrical stimulation was 5 Hz and wave form was adjustable. The intensities of the stimulation were increased in 1 mA increments to maximal tolerable intensity. At the same time, The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes. After 15 minutes treatment, acupuncture needles were removed and magnet pellets were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
Eligibility Criteria
You may qualify if:
- Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for Opioid Use Disorder and had been received methadone maintenance treatment for more then one month.
You may not qualify if:
- 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
- had epilepsy, cerebral vascular disease and brain injured history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lu-Tung Christian Hospital
Changhua, 505, Taiwan
Related Publications (3)
Chan YY, Lo WY, Li TC, Shen LJ, Yang SN, Chen YH, Lin JG. Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. Am J Chin Med. 2014;42(3):569-86. doi: 10.1142/S0192415X14500372.
PMID: 24871652BACKGROUNDLin JG, Chan YY, Chen YH. Acupuncture for the treatment of opiate addiction. Evid Based Complement Alternat Med. 2012;2012:739045. doi: 10.1155/2012/739045. Epub 2012 Feb 22.
PMID: 22474521BACKGROUNDBoyuan Z, Yang C, Ke C, Xueyong S, Sheng L. Efficacy of acupuncture for psychological symptoms associated with opioid addiction: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:313549. doi: 10.1155/2014/313549. Epub 2014 Nov 4.
PMID: 25530779BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Chen Ouyang, Ph.D.
Lu-Tung Christian Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Superintendent
Study Record Dates
First Submitted
October 29, 2016
First Posted
January 6, 2017
Study Start
June 1, 2016
Primary Completion
March 30, 2018
Study Completion
May 30, 2018
Last Updated
December 5, 2017
Record last verified: 2017-12