NCT03881618

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 21, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

October 2, 2018

Last Update Submit

March 16, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

    20 months

  • 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.

    20 months

  • 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.

    20 months

  • 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.

    20 months

  • 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.

    20 months

  • 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.

    20 months

  • 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.

    20 months

  • 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.

    20 months

Study Arms (2)

electroacupuncture+auricular pressure

EXPERIMENTAL

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

Procedure: electroacupuncture+auricular pressure,

auricular pressure

ACTIVE COMPARATOR

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

Procedure: electroacupuncture+auricular pressure,

Interventions

electroacupuncture+auricular pressure for 20 minutes

Also known as: auricular pressure
auricular pressureelectroacupuncture+auricular pressure

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan

Taipei County, Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • YU Kai-Chiang

    Chinese Medicine Center Medical Office

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 2, 2018

First Posted

March 19, 2019

Study Start

April 21, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations