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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Shanghai Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Shanghai Center of Biomedicine Development
Information provided by (Responsible Party):
Min ZHAO, Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT01580163
First received: April 17, 2012
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Heroin Addiction
Drug: JITAI Combined with psychological intervention
Drug: Methadone
Drug: Traditional Chinese Medicine JITAI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification

Resource links provided by NLM:


Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:
  • The drug use pattern during observation period [ Time Frame: Baseline ,26 weeks and 52 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The change of ASI(Addiction Severity Index) after the treatment and observation [ Time Frame: Baseline,26weeks and 52 weeks ] [ Designated as safety issue: No ]
    The investigator will use ASI to describe the addiction severity of objects and compare the different change among different groups during observation period.

  • the change of drug use pattern during observation period [ Time Frame: Baseline,26weeks and 52 weeks ] [ Designated as safety issue: No ]
    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.

  • the change of SF-36(the MOS item short form health survey) after treatment and observation [ Time Frame: Baseline,26 weeks and 52 weeks ] [ Designated as safety issue: No ]
    The investigator will use SF-36 to describe the health status of objects and compare the different change among different groups during observation period.

  • the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period [ Time Frame: Baseline ,26weeks and 52 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 930
Study Start Date: September 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JITAI combined therapy group
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
Drug: JITAI Combined with psychological intervention
tablet,Each tablet weight 0.4g
Other Name: JITAI combined with psychological intervention
Experimental: Methadone combined herapy group
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
Drug: Methadone
Oral Solution,1mg/ml
Other Name: Methadone
Experimental: JITAI therapy group
The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.
Drug: Traditional Chinese Medicine JITAI
tablet,Each tablet weight 0.4g
Other Name: JITAI

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580163

Contacts
Contact: Min ZHAO, Ph.D. 86 21 64387250 ext 3250 drzhaomin@163.com
Contact: Haifeng JIANG, M.D. 13918530826

Locations
China, Beijing
National Institute on Drug Dependence,Peking University Recruiting
Beijing, Beijing, China
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
Sponsors and Collaborators
Shanghai Mental Health Center
Shanghai Center of Biomedicine Development
Investigators
Principal Investigator: Min ZHAO, Ph.D. Shanghai Mental Health Center
  More Information

No publications provided

Responsible Party: Min ZHAO, vise president, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT01580163     History of Changes
Other Study ID Numbers: MZhao-002
Study First Received: April 17, 2012
Last Updated: April 27, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Mental Health Center:
the opioid dependence in rehabilitation phase
community

Additional relevant MeSH terms:
Heroin Dependence
Behavior, Addictive
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 20, 2014