Amphetamine AddictionNCT02713815
Novel Intervention for Amphetamine-type Stimulants Addiction
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Amphetamine Addiction
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Dextromanual
Who cannot join
- Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
- Have cognitive-promoting drugs in the last 6 months
- Other substance abuse or dependence in recent five years (except nicotine)
- Mental impairment, Intelligence Quotient (IQ) < 70
- Mental disorders
- Physical disease
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Gaojing Rehabilitation Center
Shanghai, Shanghai Municipality, 201900
About this study
Official title: The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction
The repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.
Read the detailed description
The Glutamate and GABA deficits in prefrontal cortex play a vital role in ATS addiction and relapse, and proposed repetitive transcranial magnetic stimulation (rTMS) as a novel interventions. Focused on evaluating Glutamate/GABA functions in prefrontal cortex and functional connectivity with deep brain regions, neuropsychological tests, biochemical tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to investigate the neurobiological mechanism of ATS addiction and relapse. These methods will also be used to evaluate the efficacy of the novel intervention and investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.
- Conditions
- Amphetamine Addiction
- Being tested
- repetitive transcranial magnetic stimulation (rTMS), sham repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, Glutamate/GABA, motivational and cognitive intervention
- 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.
repetitive transcranial magnetic stimulation (rTMS)Radiation
Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day
sham repetitive transcranial magnetic stimulation (rTMS)Radiation
Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | sham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. Receives: Radiation: sham repetitive transcranial magnetic stimulation (rTMS) |
| rTMS group | 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: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
Measured: Baseline and 1 month
Secondary outcomes (5)
Number of participants who relapse
Follow up with patients after discharge, evaluate number of participants who relapse
Measured: 1 month
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9)
Measured: 1 month
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7)
Measured: 1 month
Cognitive function assessed by Cogstate Battery
evaluate all participants' cognition by Cogstate Battery Chinese version
Measured: 1 month
Functional connectivity assessed by MRI
evaluate all participants' functional connectivity in the brain by MRI
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019
- Study completionJul 2019
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.
- 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
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan Institute For Drug Abuse
- Responsible party
- Sponsor
- Investigators
- Zhao Min, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713815
- Sponsor's protocol ID
- Mzhao-004
- Status last verified
- Nov 2019
- First submitted
- 7 Mar 2016
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction
- ClinicalTrials.gov ID
- NCT02713815
- Acronym / sponsor ID
- Mzhao-004
- Conditions
- Amphetamine Addiction
- Keywords
- Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, Glutamate/GABA, motivational and cognitive intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Yunnan Institute For Drug Abuse
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Mar 2016 (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 repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.
Detailed description
The Glutamate and GABA deficits in prefrontal cortex play a vital role in ATS addiction and relapse, and proposed repetitive transcranial magnetic stimulation (rTMS) as a novel interventions. Focused on evaluating Glutamate/GABA functions in prefrontal cortex and functional connectivity with deep brain regions, neuropsychological tests, biochemical tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to investigate the neurobiological mechanism of ATS addiction and relapse. These methods will also be used to evaluate the efficacy of the novel intervention and investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Radiation: sham repetitive transcranial magnetic stimulation (rTMS)sham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. |
| rTMS group | Active comparator | Radiation: repetitive transcranial magnetic stimulation (rTMS)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Dextromanual
Key exclusion criteria (6 listed)
- Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
- Have cognitive-promoting drugs in the last 6 months
- Other substance abuse or dependence in recent five years (except nicotine)
- Mental impairment, Intelligence Quotient (IQ) < 70
- Mental disorders
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day | Radiation | rTMS group |
| sham repetitive transcranial magnetic stimulation (rTMS)Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day | Radiation | control group |
Primary outcome
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month
Time frame: Baseline and 1 month
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
5 secondary outcomes
Number of participants who relapse
Time frame: 1 month
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
Time frame: 1 month
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
Time frame: 1 month
Cognitive function assessed by Cogstate Battery
Time frame: 1 month
Functional connectivity assessed by MRI
Time frame: 1 month
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 3 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Zhao Min, PhD 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 repetitive transcranial magnetic stimulation (rTMS) 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 2 inclusion and 6 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 3 Dec 2019. 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?
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month (time frame: Baseline and 1 month). 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 3 Dec 2019.