Heroin DependenceNCT01144390
Effect Study of Optimized Intervention to Heroin Addicts
A study testing cognitive behavioral therapy and methadone maintenance treatment in people with Heroin Dependence, run by Shanghai Mental Health Center at 4 sites in China.
Trial summary
The purpose of this study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based MMT clinics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- cognitive behavioral therapy and methadone maintenance treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesChina
- Study dates
- Apr 2010to Jun 2011
- 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 heroin dependence
- must be able to take methadone
Who cannot join
- schizophrenia and mood disorder
- physical disabilities who could not come to take part in psychotherapy sessions.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Mental Health Center of Hongkou District
Shanghai, Shanghai Municipality, 200030
Mental Health Center of Pudong District
Shanghai, Shanghai Municipality, 200030
Mental Health Center of Xuhui District
Shanghai, Shanghai Municipality, 200030
Mental Health Center of Yangpu District
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Barriers and Effect of Optimizing Intervention Protocols for Heroin Dependence in Community-based Methadone Maintenance Treatment (MMT): a Cohort Study
The purpose of this study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based MMT clinics.
Read the detailed description
Drug dependence is one of the most serious public health problems worldwide. In China, among more than 100, 0000 registered drug addicts mostly are heroin dependence. Drug dependence post great risks to physical condition, their family and society, and can lead to infectious disease transmission. Though almost 500 MMT clinics which can offer MMT service to heroin addicts have been set up, there are still some problems, for example, poor compliance, high rate of dropping out and relapse which affect the service delivery to them. The guideline developed by WHO focused on psychotherapy to opiate addicts with MMT. So delivery of a set of comprehensive, integrated psychotherapy to opiate addicts is very critical in such methadone clinics.
- Conditions
- Heroin Dependence
- Being tested
- cognitive behavioral therapy, methadone maintenance treatment
- Keywords
- heroin dependence, community-based, MMT
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
cognitive behavioral therapy, one session per week and psycho-education lecture in group once per month
methadone maintenance treatmentDrug
methadone maintenance treatment
| Study group | Role | What they receive |
|---|---|---|
| CBT plus MMT | Experimental | cognitive behavioral therapy for heroin addicts with methadone maintenance treatment Receives: Behavioral: cognitive behavioral therapy; Drug: methadone maintenance treatment |
| methadone maintenance treatment | Active comparator | methadone maintenance treatment for heroin addicts Receives: Drug: methadone maintenance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment retention
retaining patients in the methadone maintenance treatment during and after the study.
Measured: 12 months
Secondary outcomes (1)
in-treatment performance.
treatment performance of addicts include: treatment sessions during the study, negative urine specimens, drop-out rate, severity of ASI,scores of HIV-related high risk sexual behavior, the temperature and character inventory, perceived stigma scale, self-esteem inventory,self efficacy, social support scores,drug use from self-report from baseline to 3 month and 6 month.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Investigators
- min ZHAO, Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144390
- Sponsor's protocol ID
- ShanghaiMHC
- Status last verified
- Mar 2011
- First submitted
- 11 Jun 2010
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pan S, Jiang H, Du J, Chen H, Li Z, Ling W, Zhao M. Efficacy of Cognitive Behavioral Therapy on Opiate Use and Retention in Methadone Maintenance Treatment in China: A Randomised Trial. PLoS One. 2015 Jun 24;10(6):e0127598. doi: 10.1371/journal.pone.0127598. eCollection 2015.
PubMed 26107818
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Effect of Optimizing Intervention Protocols for Heroin Dependence in Community-based Methadone Maintenance Treatment (MMT): a Cohort Study
- ClinicalTrials.gov ID
- NCT01144390
- Acronym / sponsor ID
- ShanghaiMHC
- Conditions
- Heroin Dependence
- Keywords
- heroin dependence, community-based, MMT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 15 Jun 2010 (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 study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based MMT clinics.
Detailed description
Drug dependence is one of the most serious public health problems worldwide. In China, among more than 100, 0000 registered drug addicts mostly are heroin dependence. Drug dependence post great risks to physical condition, their family and society, and can lead to infectious disease transmission. Though almost 500 MMT clinics which can offer MMT service to heroin addicts have been set up, there are still some problems, for example, poor compliance, high rate of dropping out and relapse which affect the service delivery to them. The guideline developed by WHO focused on psychotherapy to opiate addicts with MMT. So delivery of a set of comprehensive, integrated psychotherapy to opiate addicts is very critical in such methadone clinics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT plus MMT | Experimental | Behavioral: cognitive behavioral therapy, Drug: methadone maintenance treatmentcognitive behavioral therapy for heroin addicts with methadone maintenance treatment |
| methadone maintenance treatment | Active comparator | Drug: methadone maintenance treatmentmethadone maintenance treatment for heroin addicts |
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 heroin dependence
- must be able to take methadone
Key exclusion criteria (2 listed)
- schizophrenia and mood disorder
- physical disabilities who could not come to take part in psychotherapy sessions.
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 |
|---|---|---|
| cognitive behavioral therapycognitive behavioral therapy, one session per week and psycho-education lecture in group once per month | Behavioural | CBT plus MMT |
| methadone maintenance treatmentmethadone maintenance treatment | Drug | CBT plus MMT, methadone maintenance treatment |
Primary outcome
treatment retention
Time frame: 12 months
retaining patients in the methadone maintenance treatment during and after the study.
1 secondary outcome
in-treatment performance.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
- Derived from this study: PubMed 26107818Pan S, Jiang H, Du J, Chen H, Li Z, Ling W, Zhao M. Efficacy of Cognitive Behavioral Therapy on Opiate Use and Retention in Methadone Maintenance Treatment in China: A Randomised Trial. PLoS One. 2015 Jun 24;10(6):e0127598. doi: 10.1371/journal.pone.0127598. eCollection 2015.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy and methadone maintenance treatment in people with Heroin Dependence, run by Shanghai Mental Health Center at 4 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 2 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: status not confirmed, as of the sponsor's last update on 11 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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?
treatment retention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01144390, which also lists 1 linked publication.
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 11 Mar 2011.