Amphetamine AddictionNCT02285556
The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
A study testing psychological rehabilitation training, physical and neurological rehabilitation training and rTMS 10HZ high frequency stimulation in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this research is to inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Amphetamine Addiction
- What is being tested?
- psychological rehabilitation training, physical and neurological rehabilitation training and rTMS 10HZ high frequency stimulation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Nov 2014
- 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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- No previous history of any mental disorder meet the DSM-IV diagnosis
- aged 18-49 years old , men and women
- junior high school or higher education
- use of amphetamine-type substances time for more than one year
- cumulative use of amphetamines, substances dose of 50 grams or more.
Who cannot join
- Current or past had suffered neurological diseases
- exclusion of antisocial personality disorder and borderline personality disorder
- addicts in addition to other substances in tobacco , coffee, social drinking outside
- AIDS virus (HIV) detection positive patients .
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage.
Read the detailed description
The study will increase the sample size based on the preliminary work,also, establish drug dependence induced craving associated environmental experiments , by using the multi-lead biofeedback instrument , CogState tester, event-related potentials Recorder and 3.0T high-field magnetic resonance imaging system to record the physiology , electrophysiology and brain changes during craving, taking a subjective self-assessment , clinical observations and physiological responses combined system to evaluate the ATS addiction degree.
- Conditions
- Amphetamine Addiction
- Being tested
- psychological rehabilitation training, physical and neurological rehabilitation training, rTMS 10HZ high frequency stimulation, fake rTMS 10HZ high frequency stimulation
- Keywords
- drug carving changes during rehabilitation, community, DNA
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological rehabilitation trainingBehavioural
The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.
physical and neurological rehabilitation trainingBehavioural
The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .
rTMS 10HZ high frequency stimulationRadiation
Stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).
fake rTMS 10HZ high frequency stimulationRadiation
Fake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).
| Study group | Role | What they receive |
|---|---|---|
| general information | No intervention | use cross-sectional study to collect 1000 ATS abuse or dependence patients' general information and 5 ml blood,get their blood plasma and DNA sample in order to explore the possible addict mechanism. |
| ATS diagnosis and evaluation for abusers | No intervention | Use cohort study design to establish ATS abuse induced craving experiment.Do the initial and follow-up assessment from start smoking to stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . Thus compare with normal group to explore the possible psychological abuse mechanism. |
| psychological training intervention | Active comparator | The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on. Receives: Behavioral: psychological rehabilitation training |
| brain stimulation intervention | Active comparator | Use randomized, prospective pseudo stimulus controlled clinical trial design, evaluation of repetitive transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. Receives: Radiation: rTMS 10HZ high frequency stimulation |
| ATS diagnosis and evaluation for normal people | No intervention | Do the same initial and follow-up assessment as ATS abusers who stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . |
| physical and neurological rehabilitation | Active comparator | The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes . Receives: Behavioral: physical and neurological rehabilitation training |
| fake brain stimulation intervention | Placebo comparator | fake transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. Receives: Radiation: fake rTMS 10HZ high frequency stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of ATS abuse or dependence characteristics and pathogenesis
Plasma and DNA samples were collected to carry out the biochemical genetics and immunology research of ATS abuse or dependence , and to explore the prevalence of ATS abuse or dependence characteristics and pathogenesis.
Measured: Baseline
the physiological psychology and cognitive impairment characteristic of ATS addicts,trends and ATS conducted cases.
Use repeatable battery for the assessment of neuropsychological status(RBANS),Cog-state cognitive function assessment test,event-related potentials(ERPs),functional magnetic resonance imaging(fMRI) in biology ( molecular genetics, blood biochemistry, electrophysiology , imaging ) , psychology, mental health and other aspects of the system to assess the physiological psychology and cognitive impairment characteristic of ATS addicts , trends and ATS conducted cases.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- 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
- NCT02285556
- Sponsor's protocol ID
- MZhao-003
- Status last verified
- Nov 2015
- First submitted
- 19 Aug 2014
- 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
- The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
- ClinicalTrials.gov ID
- NCT02285556
- Acronym / sponsor ID
- MZhao-003
- Conditions
- Amphetamine Addiction
- Keywords
- drug carving changes during rehabilitation, community, DNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Nov 2014 (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 inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage.
Detailed description
The study will increase the sample size based on the preliminary work,also, establish drug dependence induced craving associated environmental experiments , by using the multi-lead biofeedback instrument , CogState tester, event-related potentials Recorder and 3.0T high-field magnetic resonance imaging system to record the physiology , electrophysiology and brain changes during craving, taking a subjective self-assessment , clinical observations and physiological responses combined system to evaluate the ATS addiction degree.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| general information | No intervention | –use cross-sectional study to collect 1000 ATS abuse or dependence patients' general information and 5 ml blood,get their blood plasma and DNA sample in order to explore the possible addict mechanism. |
| ATS diagnosis and evaluation for abusers | No intervention | –Use cohort study design to establish ATS abuse induced craving experiment.Do the initial and follow-up assessment from start smoking to stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . Thus compare with normal group to explore the possible psychological abuse mechanism. |
| psychological training intervention | Active comparator | Behavioral: psychological rehabilitation trainingThe main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on. |
| brain stimulation intervention | Active comparator | Radiation: rTMS 10HZ high frequency stimulationUse randomized, prospective pseudo stimulus controlled clinical trial design, evaluation of repetitive transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. |
| ATS diagnosis and evaluation for normal people | No intervention | –Do the same initial and follow-up assessment as ATS abusers who stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . |
| physical and neurological rehabilitation | Active comparator | Behavioral: physical and neurological rehabilitation trainingThe main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes . |
| fake brain stimulation intervention | Placebo comparator | Radiation: fake rTMS 10HZ high frequency stimulationfake transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No previous history of any mental disorder meet the DSM-IV diagnosis
- aged 18-49 years old , men and women
- junior high school or higher education
- use of amphetamine-type substances time for more than one year
- cumulative use of amphetamines, substances dose of 50 grams or more.
Key exclusion criteria (4 listed)
- Current or past had suffered neurological diseases
- exclusion of antisocial personality disorder and borderline personality disorder
- addicts in addition to other substances in tobacco , coffee, social drinking outside
- AIDS virus (HIV) detection positive patients .
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 |
|---|---|---|
| psychological rehabilitation trainingThe main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on. | Behavioural | psychological training intervention |
| physical and neurological rehabilitation trainingThe main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes . | Behavioural | physical and neurological rehabilitation |
| rTMS 10HZ high frequency stimulationStimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week). | Radiation | brain stimulation intervention |
| fake rTMS 10HZ high frequency stimulationFake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week). | Radiation | fake brain stimulation intervention |
Primary outcome
the prevalence of ATS abuse or dependence characteristics and pathogenesis
Time frame: Baseline
Plasma and DNA samples were collected to carry out the biochemical genetics and immunology research of ATS abuse or dependence , and to explore the prevalence of ATS abuse or dependence characteristics and pathogenesis.
the physiological psychology and cognitive impairment characteristic of ATS addicts,trends and ATS conducted cases.
Time frame: Baseline
Use repeatable battery for the assessment of neuropsychological status(RBANS),Cog-state cognitive function assessment test,event-related potentials(ERPs),functional magnetic resonance imaging(fMRI) in biology ( molecular genetics, blood biochemistry, electrophysiology , imaging ) , psychology, mental health and other aspects of the system to assess the physiological psychology and cognitive impairment characteristic of ATS addicts , trends and ATS conducted cases.
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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological rehabilitation training, physical and neurological rehabilitation training and rTMS 10HZ high frequency stimulation in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site 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 5 inclusion and 4 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 1 site 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. Some participants in this study may receive a placebo. 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 prevalence of ATS abuse or dependence characteristics and pathogenesis (time frame: Baseline). The study lists 2 primary outcomes in all. 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.