Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
This study is currently recruiting participants.
Verified April 2012 by Shanghai Mental Health Center
Sponsor:
Shanghai Mental Health Center
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
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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
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 Mental Disorders Compulsive Behavior Impulsive Behavior Methadone Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013