Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification

Heroin Addiction Clinical Trial

Official title:

Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580163
• Other study ID #: MZhao-002
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: November 16, 2015
• Start date: September 2009
• Est. completion date: August 2013

Study information

• Verified date: November 2015
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence

Intervention

Drug:
• JITAI Combined with psychological intervention
tablet,Each tablet weight 0.4g
• Methadone
Oral Solution,1mg/ml
• Traditional Chinese Medicine JITAI
tablet,Each tablet weight 0.4g

Locations

Country	Name	City	State
China	National Institute on Drug Dependence,Peking University	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai Center of Biomedicine Development

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The drug use pattern during observation period	The investigator will ues NHI(Nature History Interview) to describe the drug use pattern and and compare the different change among different groups during observation period	Baseline ,26 weeks and 52 weeks	No
Secondary	The change of ASI(Addiction Severity Index) after the treatment and observation	The investigator will use ASI to describe the addiction severity of objects and compare the different change among different groups during observation period.	Baseline,26weeks and 52 weeks	No
Secondary	the change of drug use pattern during observation period	The investigator will ues NHI(Nature History Interview) to describe the drug use pattern and and compare the different change among different groups during observation period.	Baseline,26weeks and 52 weeks	No
Secondary	the change of SF-36(the MOS item short form health survey) after treatment and observation	The investigator will use SF-36 to describe the health status of objects and compare the different change among different groups during observation period.	Baseline,26 weeks and 52 weeks	No
Secondary	the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period	The investigator will use SAS and SDS to describe the anxiety status and depression status then compare the different change among different groups during observation period.	Baseline ,26weeks and 52 weeks	No