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

Shanghai Mental Health Center

Status: Completed

Conditions: Heroin Addiction

Treatments: Drug: JITAI Combined with psychological intervention; Drug: Methadone; Drug: Traditional Chinese Medicine JITAI

Study type: Interventional

Funder types: Other

Identifiers

NCT01580163

MZhao-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 554 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

554 participants in 3 patient groups

JITAI combined therapy group

Experimental group

Description:

The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.

Treatment:

Drug: JITAI Combined with psychological intervention

Methadone combined herapy group

Experimental group

Description:

The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.

Treatment:

Drug: Methadone

JITAI therapy group

Experimental group

Description:

The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.

Treatment:

Drug: Traditional Chinese Medicine JITAI