Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts
NCT ID: NCT03012373
Last Updated: 2017-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-06-30
2018-05-30
Brief Summary
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Detailed Description
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Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20) receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week wash-out period. Then ear acupressure alone for another four weeks.
Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week wash-out period, then ear acupressure combined with electroacupuncture for another four weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of treatment, to screen opiate reuse.
The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Ear acupressure & Electroacupuncture (A)
Electroacupuncture 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 alone
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.
Electroacupuncture plus ear acupressure
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.
Ear acupressure & Electroacupuncture (B)
Electroacupuncture 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 alone
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.
Electroacupuncture plus ear acupressure
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.
Interventions
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Ear acupressure alone
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.
Electroacupuncture plus ear acupressure
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. had severe adverse effects or events history from receiving acupuncture treatment
3. had any serious physical illness
4. had a significant risk of suicide
5. ear infection
6. were pregnant or or a woman plan to pregnant
7. had bleeding disorders or were taking anticoagulant drugs
8. had epilepsy, cerebral vascular disease and brain injured history.
20 Years
65 Years
ALL
No
Sponsors
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Lu-Tung Christian Hospital
OTHER
Responsible Party
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Wen-Chen Ouyang
Superintendent
Principal Investigators
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Wen-Chen Ouyang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Lu-Tung Christian Hospital
Locations
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Lu-Tung Christian Hospital
Changhua, , Taiwan
Countries
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References
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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.
Lin 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.
Boyuan 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.
Other Identifiers
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LuTungCH-1
Identifier Type: -
Identifier Source: org_study_id