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Completed

NCT Number: NCT01580163

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

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

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Key information

Conditions

Heroin Addiction Chemically-Induced Disorders Heroin Dependence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute on Drug Dependence，Peking University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JITAI Combined with psychological intervention

Drug

tablet，Each tablet weight 0.4g

Methadone

Drug

Oral Solution，1mg/ml

Traditional Chinese Medicine JITAI

Drug

tablet，Each tablet weight 0.4g

Other names: JITAI

Primary outcomes

  1. The drug use pattern during observation period

    Time frame: Baseline ,26 weeks and 52 weeks

    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

Secondary outcomes

  1. The change of ASI(Addiction Severity Index) after the treatment and observation

    Time frame: Baseline,26weeks and 52 weeks

    The investigator will use ASI to describe the addiction severity of objects and compare the different change among different groups during observation period.

  2. the change of drug use pattern during observation period

    Time frame: Baseline,26weeks and 52 weeks

    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.

  3. the change of SF-36(the MOS item short form health survey) after treatment and observation

    Time frame: Baseline,26 weeks and 52 weeks

    The investigator will use SF-36 to describe the health status of objects and compare the different change among different groups during observation period.

  4. the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period

    Time frame: Baseline ,26weeks and 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • Shanghai Center of Biomedicine Development

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2012
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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