Status:
COMPLETED
Clinical Efficacy and Serum Proteomic Profiling of Suan-Zao-Ren Tang for Sleep Disturbance During Methadone Maintenance
Lead Sponsor:
China Medical University, Taiwan
Conditions:
Opiate Dependence
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of Suan-Zao-Ren Tang in improving sleep quality, anxiety, depression, and heroin craving among methadone-maintained persons with sleep complaints.
Detailed Description
Background: Heroin dependence is one of the major health issues worldwide. Methadone Maintenance Therapy (MMT) is an effective treatment for opioid dependence, but more than three quarters of persons...
Eligibility Criteria
Inclusion
- aged over 20 years
- patients fulfilled the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence
- patients had been receiving MMT for more than one month
- patients have sleep disturbance complains and with Pittsburgh sleep quality index (PSQI) of greater than six
- Must be able to signed informed consent
Exclusion
- had received any antidepressant or neuroleptic medication
- had received any TCM treatment during the previous 30 days
- had any serious physical or mental illness
- had a significant risk of suicide
- pregnancy
- inability to read and fill out the forms for the study
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01913418
Start Date
July 1 2013
End Date
March 1 2014
Last Update
March 18 2014
Active Locations (1)
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1
Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan
Taoyuan District, Taiwan, 325