CClinicalTrials.gg
Status unknownNCT03881618Updated Mar 19, 2019

Efficacy of Electro-Acupuncture Therapy for Patients With Methadone Maintenance Treatment

An interventional study of electroacupuncture+auricular pressure, in Sleep Disorder (Disorder), sponsored by Taipei City Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-19.

Sponsored by Taipei City Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Apr 2017, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

The population of drug abuse(heroin) had reached about 200,000 in Taiwan, and the age distribution is mainly in young adults. The social, medical and economic problems of drug addiction are profound and include lost productivity, disrupted relationships, crime and violence, HIV/AIDS and other infectious diseases. Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years.

This research is aim to build a development model. First of all, investigators plan to review some convincing articles and then analyze the efficacy of TCM in drug addiction. According to review articles and experience of professionals, investigators establish a model for TCM included in addiction treatment. Investigators will cooperate with Western medicine together , through common assessment scales to confirm the efficacy of traditional Chinese medicine and compare with current routine treatment.

Read the detailed description

Drug addiction is a chronic medical illness and an important public health problem worldwide. The population of drug abuse had reached about 200,000 in Taiwan, and the age distribution is mainly in young adults. The social, medical and economic problems of drug addiction are profound and include lost productivity, disrupted relationships, crime and violence, HIV/AIDS and other infectious diseases. Therefore, drug addiction treatment is a hot issue of Ministry of Health and Welfare . Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. Therefore, adjuvant therapeutic interventions for drug addiction patients are needed. Contrast to conventional Western medicine, traditional Chinese medicine is the most common used therapy of complementary and alternative medicine. However, traditional Chinese medicine (TCM) was excluded from the service for drug addiction treatment. Investigators need to establish a model for TCM as an alternative therapy included in addiction treatment and provide a better care system for drug addiction.

This research is aim to build a development model. First of all, investigators plan to review some convincing articles and then analyze the efficacy of TCM in drug addiction. According to review articles and experience of professionals, we establish a model for TCM included in addiction treatment. Investigators will cooperate with Western medicine together , through common assessment scales to confirm the efficacy of traditional Chinese medicine and compare with current routine treatment. According to above experience, investigators provide a Standard Operation Procedure for TCM treatment for drug addiction and policy suggestion. For drug addiction , this factually achieves communication and integration of Chinese and Western medicine, and benefits the public.

02

Conditions studied

  • Sleep Disorder (Disorder)
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's planned enrollment of 40 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Taipei City Hospital is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Comply with Diagnostic Guidelines for Mental Disorders (DSM-V) for diagnosis of opioid use disorders
  • Rules accepting Methadone Maintenance Therapy
  • Patients between the ages of 20 and 65.

Exclusion criteria

Exclusion Criteria:

  • Unacceptable for research content.
  • The detector cannot be completed.
  • Unwilling to cooperate with acupuncture and ear beans.
  • Those whose vital signs are unstable.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    electroacupuncture+auricular pressure

    a group :electroacupuncture+auricular pressure for 20 minutes twice a week for 4 weeks

    Procedure: electroacupuncture+auricular pressure,

  • Active comparator
    auricular pressure

    b group :auricular pressure for 20 minutes twice a week for 4 weeks.

    Procedure: electroacupuncture+auricular pressure,

Interventions

  • Procedureelectroacupuncture+auricular pressure,

    electroacupuncture+auricular pressure for 20 minutes

    Also known as: auricular pressure

06

What researchers measure

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    The highest score in the whole questionnaire is 21 point, and the lowest score is 0 points.The lower the score, the better the sleep quality

    Time frame: 20 months

  2. Severity of Dependence Scale

    The highest score in the whole questionnaire is 15 point, and the lowest score is 0 points. The higher the score, the worse of the severity of dependence.

    Time frame: 20 months

  3. Visual analogue scale

    The highest score in the whole questionnaire is 10 point, and the lowest score is 0 points. The higher the score, the more serious of the pain.

    Time frame: 20 months

  4. Clinical Opiate Withdrawal Scale

    The highest score in the whole questionnaire is 55 point, and the lowest score is 0 points. The higher the score, the more serious of the Withdrawal symptom.

    Time frame: 20 months

  5. Beck Depression Inventory

    The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points. The higher the score, the more serious of depression.

    Time frame: 20 months

  6. Beck Anxiety Inventory

    The highest score in the whole questionnaire is 63 point, and the lowest score is 0 points. The higher the score, the more serious of anxiety.

    Time frame: 20 months

  7. The Short Form (36) Health Survey

    The highest score in the whole questionnaire is 100 point, and the lowest score is 0 points. The lower the score, the better quality of life.

    Time frame: 20 months

  8. Craving Scale

    The highest score in the whole questionnaire is 108 point, and the lowest score is 0 points. The higher the score, the more serious of craving behavior.

    Time frame: 20 months

07

Study locations

1 of 1 sites recruiting
  • Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan
    Taipei county, Taipei, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03881618
Lead sponsor
Taipei City Hospital
Responsible party
Chung-Hua Hsu (Clinical Professor, Taipei City Hospital) — Principal investigator
First posted
Mar 19, 2019
Start date
Apr 21, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019 (estimated)
Last update
Mar 19, 2019

Study contacts

Yu Kai-Chiang
Contact
dau70@tpech.gov.tw
8860978157553
YU Kai-Chiang
principal investigator · Chinese Medicine Center Medical Office

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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