Clinical trial NCT03881618: Efficacy of Electro-Acupuncture Therapy for Patients With Methadone Maintenance Treatment
Official title: the Efficacy of Electro-acupuncture Therapy for Patients With Methadone Maintenance Treatment : a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder (Disorder)
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2019-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 months
measure: Severity of Dependence Scale
timeFrame: 20 months
measure: Visual analogue scale
timeFrame: 20 months
measure: Clinical Opiate Withdrawal Scale
timeFrame: 20 months
measure: Beck Depression Inventory
timeFrame: 20 months
measure: Beck Anxiety Inventory
timeFrame: 20 months
measure: The Short Form (36) Health Survey
timeFrame: 20 months
measure: Craving Scale
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan
state: Taipei
Study officials:
affiliation: Chinese Medicine Center Medical Office
name: YU Kai-Chiang
role: PRINCIPAL_INVESTIGATOR
References: