Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03881618
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Sleep Disorder (Disorder) Procedure: electroacupuncture+auricular pressure, Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: two group . a group and b group. the intervention of a group is electroacupuncture + auricular pressure and b group is auricular pressure ,after intervention for 1 month and crossover.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Efficacy of Electro-acupuncture Therapy for Patients With Methadone Maintenance Treatment : a Randomized Control Trial
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
Drug Information available for: Methadone

Arm Intervention/treatment
Experimental: electroacupuncture+auricular pressure
a group :electroacupuncture+auricular pressure for 20 minutes twice a week for 4 weeks
Procedure: electroacupuncture+auricular pressure,
electroacupuncture+auricular pressure for 20 minutes
Other Name: auricular pressure

Active Comparator: auricular pressure
b group :auricular pressure for 20 minutes twice a week for 4 weeks.
Procedure: electroacupuncture+auricular pressure,
electroacupuncture+auricular pressure for 20 minutes
Other Name: auricular pressure




Primary Outcome Measures :
  1. Pittsburgh Sleep Quality Index [ Time Frame: 20 months ]
    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

  2. Severity of Dependence Scale [ Time Frame: 20 months ]
    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.

  3. Visual analogue scale [ Time Frame: 20 months ]
    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.

  4. Clinical Opiate Withdrawal Scale [ Time Frame: 20 months ]
    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.

  5. Beck Depression Inventory [ Time Frame: 20 months ]
    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.

  6. Beck Anxiety Inventory [ Time Frame: 20 months ]
    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.

  7. The Short Form (36) Health Survey [ Time Frame: 20 months ]
    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.

  8. Craving Scale [ Time Frame: 20 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881618


Contacts
Layout table for location contacts
Contact: Yu Kai-Chiang 8860978157553 dau70@tpech.gov.tw

Locations
Layout table for location information
Taiwan
Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan Recruiting
Taipei county, Taipei, Taiwan
Contact: yu Kai-Chiang    8860978157553    dau70@tpech.gov.tw   
Sponsors and Collaborators
Taipei City Hospital
Investigators
Layout table for investigator information
Principal Investigator: YU Kai-Chiang Chinese Medicine Center Medical Office

Layout table for additonal information
Responsible Party: Chung-Hua Hsu, Clinical Professor, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT03881618     History of Changes
Other Study ID Numbers: TCHIRB-10601106
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents