Heroin AddictionNCT01580163
Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
A study testing JITAI Combined with psychological intervention, Methadone and Traditional Chinese Medicine JITAI in people with Heroin Addiction, run by Shanghai Mental Health Center at 2 sites in China.
Trial summary
The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heroin Addiction
- What is being tested?
- JITAI Combined with psychological intervention, Methadone and Traditional Chinese Medicine JITAI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of The opioid dependence
- After detoxification.
Who cannot join
- 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；
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
China2 sites
National Institute on Drug Dependence，Peking University
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
About this study
The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.
Read the 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.
- Conditions
- Heroin Addiction
- Being tested
- JITAI Combined with psychological intervention, Methadone, Traditional Chinese Medicine JITAI
- Keywords
- the opioid dependence in rehabilitation phase, community
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JITAI Combined with psychological interventionDrug
tablet，Each tablet weight 0.4g
MethadoneDrug
Oral Solution，1mg/ml
Traditional Chinese Medicine JITAIDrug
Also called JITAI
tablet，Each tablet weight 0.4g
| Study group | Role | What they receive |
|---|---|---|
| JITAI combined therapy group | Experimental | The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community. Receives: Drug: JITAI Combined with psychological intervention |
| Methadone combined herapy group | Experimental | The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community. Receives: Drug: Methadone |
| JITAI therapy group | Experimental | The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai. Receives: Drug: Traditional Chinese Medicine JITAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline ,26 weeks and 52 weeks
Secondary outcomes (4)
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.
Measured: Baseline,26weeks and 52 weeks
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.
Measured: Baseline,26weeks and 52 weeks
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.
Measured: Baseline,26 weeks and 52 weeks
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.
Measured: Baseline ,26weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin AddictionStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Center of Biomedicine Development
- Responsible party
- Principal investigator, Min ZHAO, Shanghai Mental Health Center
- Investigators
- Min ZHAO, Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580163
- Sponsor's protocol ID
- MZhao-002
- Status last verified
- Nov 2015
- First submitted
- 17 Apr 2012
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
- ClinicalTrials.gov ID
- NCT01580163
- Acronym / sponsor ID
- MZhao-002
- Conditions
- Heroin Addiction
- Keywords
- the opioid dependence in rehabilitation phase, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Center of Biomedicine Development
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JITAI combined therapy group | Experimental | Drug: JITAI Combined with psychological interventionThe investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community. |
| Methadone combined herapy group | Experimental | Drug: MethadoneThe investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community. |
| JITAI therapy group | Experimental | Drug: Traditional Chinese Medicine JITAIThe investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical Diagnosis of The opioid dependence
- After detoxification.
Key exclusion criteria (11 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JITAI Combined with psychological interventiontablet，Each tablet weight 0.4g | Drug | JITAI combined therapy group |
| MethadoneOral Solution，1mg/ml | Drug | Methadone combined herapy group |
| Traditional Chinese Medicine JITAIAlso: JITAItablet，Each tablet weight 0.4g | Drug | JITAI therapy group |
Primary outcome
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
4 secondary outcomes
The change of ASI(Addiction Severity Index) after the treatment and observation
Time frame: Baseline,26weeks and 52 weeks
the change of drug use pattern during observation period
Time frame: Baseline,26weeks and 52 weeks
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 change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period
Time frame: Baseline ,26weeks and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
Related trials for Heroin Addiction
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Enrolling by invitation
Project on tDCS Intervention to Enhance Advanced Social Cognitive Functions in Drug Rehabilitation Individuals
Drug Addiction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min ZHAO, Ph.D. principal investigator
Shanghai Mental Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JITAI Combined with psychological intervention, Methadone and Traditional Chinese Medicine JITAI in people with Heroin Addiction, run by Shanghai Mental Health Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The drug use pattern during observation period (time frame: Baseline ,26 weeks and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.