Sleep Disorder (Disorder) Clinical Trial
Official title:
the Efficacy of Electro-acupuncture Therapy for Patients With Methadone Maintenance Treatment : a Randomized Control Trial
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Department of Chinese Medicine, Taipei City Hospital, Linsen, Chinese Medicine, and Kunming Branch, Taipei, Taiwan | Taipei county | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Taipei City Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |