Amphetamine Use DisordersNCT03736317
Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder
A study testing real mPFC cTBS, real dlPFC iTBS and real dlPFC iTBS + real mPFC cTBS in people with Amphetamine Use Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Amphetamine Use Disorders
- What is being tested?
- real mPFC cTBS, real dlPFC iTBS and real dlPFC iTBS + real mPFC cTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2021
- 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 60 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
- Primary school degree or above
- Normal vision and hearing
- Dextromanual
- Less than one month before last drug use
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 Compulsory Rehabilitation Center
Shanghai, Shanghai Municipality, 201900
About this study
Official title: Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Craving in Methamphetamine Use Disorder
Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of methamphetamine-dependent patients.
Read the detailed description
The limbic circuit and executive control circuit are two important frontal-striatal neural circuits associated with drug dependence. Previous studies showed increased functional activity within the limbic neural circuit (e.g. medial prefrontal cortex (mPFC) and ventral striatum) in the presence of a salient cue and decreased activity in the executive control circuit (e.g. dorsal prefrontal cortex and dorsal striatum). TMS was used to reverse the activities of these two circuits, by using continuous TBS and intermittent TBS, respectively. In this study, vmPFC cTBS was conducted to modulating the limbic circuit, while left dlPFC iTBS was conducted to modulating the executive control circuit. Combined treatment of vmPFC cTBS and left dlPFC iTBS was conducted to modulating two circuits simultaneously. Focused on evaluating the efficacy of the interventions and investigate the mechanisms, neuropsychological tests, biochemical tests, and electroencephalography will be used to investigate the neurobiological mechanism of the methamphetamine use disorder, craving, and relapse. The study will be very helpful to develop evidence-based rTMS protocols for methamphetamine-dependent patients in clinical practice and decrease harm for both the patients and their families.
- Conditions
- Amphetamine Use Disorders
- Being tested
- sham TBS, real mPFC cTBS, real dlPFC iTBS, real dlPFC iTBS + real mPFC cTBS
- Keywords
- Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, individualized therapy, craving, relapse
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham TBSDevice
Stimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil.
real mPFC cTBSDevice
Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
real dlPFC iTBSDevice
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
real dlPFC iTBS + real mPFC cTBSDevice
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Sham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients. Stimulation pulses are the same as the real group. Receives: Device: sham TBS |
| real mPFC cTBS group | Experimental | The real cTBS stimulation pattern will be delivered on the medial prefrontal cortex. Receives: Device: real mPFC cTBS |
| real dlPFC iTBS group | Experimental | The real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex. Receives: Device: real dlPFC iTBS |
| real dlPFC iTBS + real mPFC cTBS group | Experimental | Combination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex. Receives: Device: real dlPFC iTBS + real mPFC cTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Craving assessed by Visual Analog Scale
evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
Measured: 12 months.
Secondary outcomes (6)
Number of participants who relapse
Follow up with patients after discharge, evaluate number of participants who relapse
Measured: 12 months
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression.
Measured: 12 months
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). PHQ-9 range from 0 to 21, and higher values represent more severe level of anxiety.
Measured: 12 months
Cognitive function assessed by CogState Battery (CSB)
evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version
Measured: 12 months
Response inhibition function
assessed by Go nogo task under the electroencephalogram recording
Measured: 12 months
Cue reactivity
assessed by Cue reactivity task under the electroencephalogram recording
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 posted9 Nov 2018
- Study start1 Sep 2019
- Primary completion1 Feb 2021
- Study completion1 Sep 2021
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 Amphetamine Use DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736317
- Sponsor's protocol ID
- MZhao-009
- Status last verified
- Sep 2021
- First submitted
- 6 Nov 2018
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen T, Su H, Li R, Jiang H, Li X, Wu Q, Tan H, Zhang J, Zhong N, Du J, Gu H, Zhao M. The exploration of optimized protocol for repetitive transcranial magnetic stimulation in the treatment of methamphetamine use disorder: A randomized sham-controlled study. EBioMedicine. 2020 Oct;60:103027. doi: 10.1016/j.ebiom.2020.103027. Epub 2020 Sep 25.
PubMed 32980696
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Craving in Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT03736317
- Acronym / sponsor ID
- MZhao-009
- Conditions
- Amphetamine Use Disorders
- Keywords
- Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, individualized therapy, craving, relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 9 Nov 2018 (actual)
- 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.
Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of methamphetamine-dependent patients.
Detailed description
The limbic circuit and executive control circuit are two important frontal-striatal neural circuits associated with drug dependence. Previous studies showed increased functional activity within the limbic neural circuit (e.g. medial prefrontal cortex (mPFC) and ventral striatum) in the presence of a salient cue and decreased activity in the executive control circuit (e.g. dorsal prefrontal cortex and dorsal striatum). TMS was used to reverse the activities of these two circuits, by using continuous TBS and intermittent TBS, respectively. In this study, vmPFC cTBS was conducted to modulating the limbic circuit, while left dlPFC iTBS was conducted to modulating the executive control circuit. Combined treatment of vmPFC cTBS and left dlPFC iTBS was conducted to modulating two circuits simultaneously. Focused on evaluating the efficacy of the interventions and investigate the mechanisms, neuropsychological tests, biochemical tests, and electroencephalography will be used to investigate the neurobiological mechanism of the methamphetamine use disorder, craving, and relapse. The study will be very helpful to develop evidence-based rTMS protocols for methamphetamine-dependent patients in clinical practice and decrease 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
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Device: sham TBSSham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients. Stimulation pulses are the same as the real group. |
| real mPFC cTBS group | Experimental | Device: real mPFC cTBSThe real cTBS stimulation pattern will be delivered on the medial prefrontal cortex. |
| real dlPFC iTBS group | Experimental | Device: real dlPFC iTBSThe real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex. |
| real dlPFC iTBS + real mPFC cTBS group | Experimental | Device: real dlPFC iTBS + real mPFC cTBSCombination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Primary school degree or above
- Normal vision and hearing
- Dextromanual
- Less than one month before last drug use
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 |
|---|---|---|
| sham TBSStimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil. | Device | control group |
| real mPFC cTBSStimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week. | Device | real mPFC cTBS group |
| real dlPFC iTBSStimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week. | Device | real dlPFC iTBS group |
| real dlPFC iTBS + real mPFC cTBSStimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week. | Device | real dlPFC iTBS + real mPFC cTBS group |
Primary outcome
Change of Craving assessed by Visual Analog Scale
Time frame: 12 months.
evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
6 secondary outcomes
Number of participants who relapse
Time frame: 12 months
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
Time frame: 12 months
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
Time frame: 12 months
Cognitive function assessed by CogState Battery (CSB)
Time frame: 12 months
Response inhibition function
Time frame: 12 months
Cue reactivity
Time frame: 12 months
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 16 Sep 2021.
- Derived from this study: PubMed 32980696Chen T, Su H, Li R, Jiang H, Li X, Wu Q, Tan H, Zhang J, Zhong N, Du J, Gu H, Zhao M. The exploration of optimized protocol for repetitive transcranial magnetic stimulation in the treatment of methamphetamine use disorder: A randomized sham-controlled study. EBioMedicine. 2020 Oct;60:103027. doi: 10.1016/j.ebiom.2020.103027. Epub 2020 Sep 25.
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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, 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 real mPFC cTBS, real dlPFC iTBS and real dlPFC iTBS + real mPFC cTBS in people with Amphetamine Use Disorders, 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 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 16 Sep 2021. 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 of Craving assessed by Visual Analog Scale (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 NCT03736317, 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 16 Sep 2021.