Clinical trial NCT01580163: Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
Official title: Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heroin Addiction
Keywords: the opioid dependence in rehabilitation phase
community
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Shanghai Center of Biomedicine Development
First posted: 2012-04-18
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.

Detailed description: The model include the Chinese traditional medicine JITAI combined with psychological intervention and social support for maintenance therapy after acute detoxification of heroin addicts.On the basis of the existing community management experience and community of professional anti-drug community service，The investigator will adopt the Chinese traditional medicine JITAI combined with psychological intervention and social support for maintenance therapy after acute detoxification of the community of heroin addicts.The purpose is to observe the comprehensive treatment model to improve treatment compliance and relapse prevention，then the investigator will form a new model of community humane drug treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of The opioid dependence
* After detoxification.

Exclusion Criteria：

* Clinical Diagnosis of glaucoma and other severe mental disorder；
* serious organic disease within three months；
* can not comply with the test requirements；
* accept Hans therapy instrument；
* have tendence of suicide，self-injury and impulse；
* ECG abnormalities；
* ALT or AST greater than 5 times the upper limit of normal；
* history of epilepsy；
* Lactating or pregnant women，or women of childbearing age fails to take effective contraceptive measures；
* serious history of drug allergy or known allergy on traditional Chinese medicine JITAI；
* Study before the withdrawal less than a half-life of 5.

Primary outcomes:
measure: The drug use pattern during observation period
timeFrame: Baseline ,26 weeks and 52 weeks
Secondary outcomes:
measure: The change of ASI(Addiction Severity Index) after the treatment and observation
timeFrame: Baseline,26weeks and 52 weeks
measure: the change of drug use pattern during observation period
timeFrame: Baseline,26weeks and 52 weeks
measure: the change of SF-36(the MOS item short form health survey) after treatment and observation
timeFrame: Baseline,26 weeks and 52 weeks
measure: the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period
timeFrame: Baseline ,26weeks and 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Institute on Drug Dependence，Peking University
state: Beijing
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Shanghai Mental Health Center
name: Min ZHAO, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: