Methamphetamine-dependenceNCT04202926
Repetitive dTMS Intervention for Methamphetamine Addiction
A study testing real coil in people with Methamphetamine-dependence, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
A growing body of evidence suggests a wide range of brain areas including medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (DLPFC) and other subcortical regions, such as anterior cingulate cortex (ACC) are critical for regulating cognitive control over decisions and involving in drug related cue… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Methamphetamine-dependence
- What is being tested?
- real coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2019to 30 Oct 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Methamphetamine dependents
- middle school degree or above
Who cannot join
- Have contraindications to rTMS (head trauma, epilepsy or history of epilepsy, metal implant etc.)
- psychiatric illnesses
- intellectual impairment (IQ<90)
Trial locations and contacts
1 site in 1 country.
About this study
A growing body of evidence suggests a wide range of brain areas including medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (DLPFC) and other subcortical regions, such as anterior cingulate cortex (ACC) are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial magnetic stimulation (rTMS) over dorsolateral prefrontal cortex reduces craving for meth dependences. Specifically, the H7 coil induces a magnetic field can target mPFC and ACC. In this study, the investigators investigated whether repeated dTMS intervention of medial prefrontal and cingulate cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities.
Read the detailed description
The study will be conducted at the drug rehabilitation center in China. The whole procedure includes enrollment, pre-intervention evaluation, intervention (for 3 weeks, 5 times a week, 15 times in total), post-intervention evaluation and one month follow up evaluation.
In enrollment session, participants are recruited according to inclusion criteria.
In the pre-intervention evaluation, firstly, participants need complete a questionnaire to assess their demographic information, drug addiction history and drug abstinence. And then are assigned to either 10Hz group or sham group according to the counterbalance of their basic demographic and drug use information. Then, participants need complete craving, cognitive ability and electroencephalogram (EEG) assessment. For craving assessing, participants are shown a video of methamphetamine usage for 5 minutes, and then rated on the visual analogue scale (0 means completely undesired and 100 means extremely wanting) to report their craving for methamphetamine. For cognitive ability and EEG signal assessing, the whole process is conducted on the computer according to instructions.
In the intervention session, dTMS was administered using a TMS stimulator (Magstim, U.K.) equipped with a unique H-shaped coil design. The H-coil version used in this study was the H7 (Brainsway, Jerusalem, Israel). When placed 4-5 cm anterior to the foot motor cortex and used at 100% of the leg resting motor threshold (RMT), the H7 coil stimulates the dorsal mPFC and ACC bilaterally. A participant's RMT was determined before the first treatment and at the beginning of each week by ascertaining the coil position that elicited the minimal involuntary contractions of the feet (three of six attempts). The 10Hz group received 10 Hz dTMS at 100% of RMT, with 3-second pulse and 17-second intervals, for a total of 50 trains and 1500 pulses per session. The sham group received treatment with identical technical parameters, which induced scalp sensations but without penetration of the electric field into the brain.
Post-intervention evaluation and one month follow up evaluation are the same as in pre-intervention evaluation.
To ensure study quality, some measures are taken as bellow:
Researchers and drug rehabilitation staff will work together in whole process and the data will be converted into electronic versions once finishing each evaluation.
In the intervention, patients, operators, and raters were blind to treatment condition. Each patient is assigned a magnetic card that determined the coil (real or sham) in the helmet and raters are not present while treatments are administered.
After each treatment times, any side effect from participant's report are recorded to assure the safety and feasibility.
Statistical analyses are performed using SPSS 21.0. The principal statistical analysis is performed using repeated-measures analysis of variance and regression analysis. All missing data will be recorded and marked.
- Conditions
- Methamphetamine-dependence
- Being tested
- real coil, sham coil
- Keywords
- deep transcranial magnetic stimulation, methamphetamine addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real coilDevice
active 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses
sham coilDevice
sham 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses
| Study group | Role | What they receive |
|---|---|---|
| 10hz group | Experimental | a high frequency stimulation Receives: Device: real coil |
| sham group | Sham comparator | a sham coil which frequency is 10hz but do not induce stimulation Receives: Device: sham coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Cue-induced craving and ERP
Subjective craving (cue induced, 0-100 based VAS, craving scale) and drug cue-ERP (P300 etc. measured)
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Secondary outcomes (7)
Changes of cognition: behavioral inhibition
using cognitive tasks: stop-signal task
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of cognition: working memory
using cognitive tasks: n-back task
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of depression status
depression (Beck Depression inventory scale), high score means worse depression
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of anxiety status
Anxiety (Beck anxiety inventory scale), higher score means worse anxiety
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of sleep status
sleep status measurements (Pittsburgh Sleep Quality Index scale), higher score means worse sleep
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of impulsivity
Impulsivity scale (The Barratt Impulsiveness Scale), higher score means higher impulsivity
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of resting EEG network
resting EEG signal (Alpha, Beta, Theta, etc) measurement with 128 Channel EGI system
Measured: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start30 Dec 2019
- Primary completion30 May 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine-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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tifei Yuan, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202926
- Sponsor's protocol ID
- TFYuan
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share all IPD that underlie results in a publication
Publications
Shen Y, Cao X, Tan T, Shan C, Wang Y, Pan J, He H, Yuan TF. 10-Hz Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex Reduces Heroin Cue Craving in Long-Term Addicts. Biol Psychiatry. 2016 Aug 1;80(3):e13-4. doi: 10.1016/j.biopsych.2016.02.006. Epub 2016 Feb 12. No abstract available.
PubMed 26995024Dunlop K, Hanlon CA, Downar J. Noninvasive brain stimulation treatments for addiction and major depression. Ann N Y Acad Sci. 2017 Apr;1394(1):31-54. doi: 10.1111/nyas.12985. Epub 2016 Feb 5.
PubMed 26849183Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
PubMed 31109199Liu T, Li Y, Shen Y, Liu X, Yuan TF. Gender does not matter: Add-on repetitive transcranial magnetic stimulation treatment for female methamphetamine dependents. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jun 8;92:70-75. doi: 10.1016/j.pnpbp.2018.12.018. Epub 2018 Dec 31.
PubMed 30605708Su H, Zhong N, Gan H, Wang J, Han H, Chen T, Li X, Ruan X, Zhu Y, Jiang H, Zhao M. High frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex for methamphetamine use disorders: A randomised clinical trial. Drug Alcohol Depend. 2017 Jun 1;175:84-91. doi: 10.1016/j.drugalcdep.2017.01.037. Epub 2017 Mar 29.
PubMed 28410525Liu Q, Shen Y, Cao X, Li Y, Chen Y, Yang W, Yuan TF. Either at left or right, both high and low frequency rTMS of dorsolateral prefrontal cortex decreases cue induced craving for methamphetamine. Am J Addict. 2017 Dec;26(8):776-779. doi: 10.1111/ajad.12638. Epub 2017 Nov 14.
PubMed 29134789
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive dTMS Intervention for Methamphetamine Addiction
- ClinicalTrials.gov ID
- NCT04202926
- Acronym / sponsor ID
- TFYuan
- Conditions
- Methamphetamine-dependence
- Keywords
- deep transcranial magnetic stimulation, methamphetamine addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Dec 2019 (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.
A growing body of evidence suggests a wide range of brain areas including medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (DLPFC) and other subcortical regions, such as anterior cingulate cortex (ACC) are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial magnetic stimulation (rTMS) over dorsolateral prefrontal cortex reduces craving for meth dependences. Specifically, the H7 coil induces a magnetic field can target mPFC and ACC. In this study, the investigators investigated whether repeated dTMS intervention of medial prefrontal and cingulate cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities.
Detailed description
The study will be conducted at the drug rehabilitation center in China. The whole procedure includes enrollment, pre-intervention evaluation, intervention (for 3 weeks, 5 times a week, 15 times in total), post-intervention evaluation and one month follow up evaluation.
In enrollment session, participants are recruited according to inclusion criteria.
In the pre-intervention evaluation, firstly, participants need complete a questionnaire to assess their demographic information, drug addiction history and drug abstinence. And then are assigned to either 10Hz group or sham group according to the counterbalance of their basic demographic and drug use information. Then, participants need complete craving, cognitive ability and electroencephalogram (EEG) assessment. For craving assessing, participants are shown a video of methamphetamine usage for 5 minutes, and then rated on the visual analogue scale (0 means completely undesired and 100 means extremely wanting) to report their craving for methamphetamine. For cognitive ability and EEG signal assessing, the whole process is conducted on the computer according to instructions.
In the intervention session, dTMS was administered using a TMS stimulator (Magstim, U.K.) equipped with a unique H-shaped coil design. The H-coil version used in this study was the H7 (Brainsway, Jerusalem, Israel). When placed 4-5 cm anterior to the foot motor cortex and used at 100% of the leg resting motor threshold (RMT), the H7 coil stimulates the dorsal mPFC and ACC bilaterally. A participant's RMT was determined before the first treatment and at the beginning of each week by ascertaining the coil position that elicited the minimal involuntary contractions of the feet (three of six attempts). The 10Hz group received 10 Hz dTMS at 100% of RMT, with 3-second pulse and 17-second intervals, for a total of 50 trains and 1500 pulses per session. The sham group received treatment with identical technical parameters, which induced scalp sensations but without penetration of the electric field into the brain.
Post-intervention evaluation and one month follow up evaluation are the same as in pre-intervention evaluation.
To ensure study quality, some measures are taken as bellow:
Researchers and drug rehabilitation staff will work together in whole process and the data will be converted into electronic versions once finishing each evaluation.
In the intervention, patients, operators, and raters were blind to treatment condition. Each patient is assigned a magnetic card that determined the coil (real or sham) in the helmet and raters are not present while treatments are administered.
After each treatment times, any side effect from participant's report are recorded to assure the safety and feasibility.
Statistical analyses are performed using SPSS 21.0. The principal statistical analysis is performed using repeated-measures analysis of variance and regression analysis. All missing data will be recorded and marked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10hz group | Experimental | Device: real coila high frequency stimulation |
| sham group | Sham comparator | Device: sham coila sham coil which frequency is 10hz but do not induce stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Methamphetamine dependents
- middle school degree or above
Key exclusion criteria (3 listed)
- Have contraindications to rTMS (head trauma, epilepsy or history of epilepsy, metal implant etc.)
- psychiatric illnesses
- intellectual impairment (IQ<90)
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 |
|---|---|---|
| real coilactive 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses | Device | 10hz group |
| sham coilsham 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses | Device | sham group |
Primary outcome
Changes of Cue-induced craving and ERP
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Subjective craving (cue induced, 0-100 based VAS, craving scale) and drug cue-ERP (P300 etc. measured)
7 secondary outcomes
Changes of cognition: behavioral inhibition
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of cognition: working memory
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of depression status
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of anxiety status
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of sleep status
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of impulsivity
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
Changes of resting EEG network
Time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention
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 22 Nov 2023.
- Background: PubMed 26995024Shen Y, Cao X, Tan T, Shan C, Wang Y, Pan J, He H, Yuan TF. 10-Hz Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex Reduces Heroin Cue Craving in Long-Term Addicts. Biol Psychiatry. 2016 Aug 1;80(3):e13-4. doi: 10.1016/j.biopsych.2016.02.006. Epub 2016 Feb 12. No abstract available.
- Background: PubMed 26849183Dunlop K, Hanlon CA, Downar J. Noninvasive brain stimulation treatments for addiction and major depression. Ann N Y Acad Sci. 2017 Apr;1394(1):31-54. doi: 10.1111/nyas.12985. Epub 2016 Feb 5.
- Background: PubMed 31109199Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
- Background: PubMed 30605708Liu T, Li Y, Shen Y, Liu X, Yuan TF. Gender does not matter: Add-on repetitive transcranial magnetic stimulation treatment for female methamphetamine dependents. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jun 8;92:70-75. doi: 10.1016/j.pnpbp.2018.12.018. Epub 2018 Dec 31.
- Background: PubMed 28410525Su H, Zhong N, Gan H, Wang J, Han H, Chen T, Li X, Ruan X, Zhu Y, Jiang H, Zhao M. High frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex for methamphetamine use disorders: A randomised clinical trial. Drug Alcohol Depend. 2017 Jun 1;175:84-91. doi: 10.1016/j.drugalcdep.2017.01.037. Epub 2017 Mar 29.
- Background: PubMed 29134789Liu Q, Shen Y, Cao X, Li Y, Chen Y, Yang W, Yuan TF. Either at left or right, both high and low frequency rTMS of dorsolateral prefrontal cortex decreases cue induced craving for methamphetamine. Am J Addict. 2017 Dec;26(8):776-779. doi: 10.1111/ajad.12638. Epub 2017 Nov 14.
- Individual participant dataSharing planned: Yes. share all IPD that underlie results in a publication
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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.
Tifei Yuan, 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 coil in people with Methamphetamine-dependence, 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 3 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 22 Nov 2023. 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?
Changes of Cue-induced craving and ERP (time frame: the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention). 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 NCT04202926, which also lists 6 linked publications.
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 22 Nov 2023.