Amphetamine Use DisordersNCT07479771
tTIS Targeted of the Striatum as an Intervention for MUD Patients
A study testing Temporal Interference Stimulation in people with Amphetamine Use Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Targeted temporal interference stimulation (tTIS) of the caudate nucleus can modulate the abnormal electrophysiological activity in individuals with methamphetamine use disorder (MUD), thereby improving their impaired reward-learning behaviors and reducing drug craving. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Amphetamine Use Disorders
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2026to 1 Aug 2026
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 6 years of education and capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
- Consent to actively cooperate in the completion of subsequent follow-up assessments.
Who cannot join
- Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
- A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
- Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
- Severe organic diseases that might compromise study participation.
- Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai, Shanghai, China, 200000, 200030
About this study
Official title: Transcranial Temporal Interference Stimulation Targeted of the Striatum as an Intervention for Methamphetamine Use Disorder Patients
Targeted temporal interference stimulation (tTIS) of the caudate nucleus can modulate the abnormal electrophysiological activity in individuals with methamphetamine use disorder (MUD), thereby improving their impaired reward-learning behaviors and reducing drug craving.
Read the detailed description
This project will recruit MUD patients. A 5-day intervention protocol of real or sham tTIS targeting the caudate nucleus will be employed. Before and after intervention, drug craving anddrug use and other questionnaire as well as stop-signal tasks, and reward-learning tasks will be used to evaluate its therapeutic efficacy on clinical craving and the underlying neural mechanisms.
- Conditions
- Amphetamine Use Disorders
- Being tested
- Temporal Interference Stimulation, Shame
- Keywords
- Amphetamine-type stimulants, temporal interference stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference StimulationDevice
The stimulation duration are 30 minutes per session, administered twice daily for 5 consecutive days.
ShameDevice
The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. Sham stimulation used the same montage and ramp procedures but delivered stimulation for only 1 minute per session before the stimulator was turned off.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation Group | Experimental | The first pair of electrodes continuously delivers a current at a frequency of f1 = 2 kHz, while the second pair delivers a current at f2 = 2.130 kHz. Based on the principle of temporal interference, an alternating electric field at a frequency of f1 - f2 = 130 Hz is generated in the target region. Receives: Device: Temporal Interference Stimulation |
| Control Group | Sham comparator | The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. Sham stimulation used the same montage and ramp procedures but delivered stimulation for only 1 minute per session before the stimulator was turned off. Receives: Device: Shame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Craving
Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Secondary outcomes (12)
Drug Use
OCDUSE scale
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity
This study employed the BIS-11 Impulsiveness Scale
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity
the Impulsive-Control Dual Systems Scale
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity
Stop Single Task
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Changes in Reward Learning
Reward LearningTask
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Decision-making Preferences and Delay of Gratification
delay discounting task
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
sensitivity to reward and punishment
the Sensitivity to Punishment and Sensitivity to Reward Questionnaire, the Cognitive Flexibility Scale, the Behavioral Inhibition/Activation System Scale
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
emotional states
the BDI Depression Inventory
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
emotional state
the BAI Anxiety Inventory
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
sleep quality
the PSQI Sleep Quality Index
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
EEG
source power of each frequency band
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
EEG
change of functional connection of brain area
Measured: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start26 Mar 2026
- Primary completion1 Jun 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, PhD, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479771
- Sponsor's protocol ID
- MZhao-020
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Temporal Interference Stimulation Targeted of the Striatum as an Intervention for Methamphetamine Use Disorder Patients
- ClinicalTrials.gov ID
- NCT07479771
- Acronym / sponsor ID
- MZhao-020
- Conditions
- Amphetamine Use Disorders
- Keywords
- Amphetamine-type stimulants, temporal interference stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 18 Mar 2026 (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.
Targeted temporal interference stimulation (tTIS) of the caudate nucleus can modulate the abnormal electrophysiological activity in individuals with methamphetamine use disorder (MUD), thereby improving their impaired reward-learning behaviors and reducing drug craving.
Detailed description
This project will recruit MUD patients. A 5-day intervention protocol of real or sham tTIS targeting the caudate nucleus will be employed. Before and after intervention, drug craving anddrug use and other questionnaire as well as stop-signal tasks, and reward-learning tasks will be used to evaluate its therapeutic efficacy on clinical craving and the underlying neural mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation Group | Experimental | Device: Temporal Interference StimulationThe first pair of electrodes continuously delivers a current at a frequency of f1 = 2 kHz, while the second pair delivers a current at f2 = 2.130 kHz. Based on the principle of temporal interference, an alternating electric field at a frequency of f1 - f2 = 130 Hz is generated in the target region. |
| Control Group | Sham comparator | Device: ShameThe stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. Sham stimulation used the same montage and ramp procedures but delivered stimulation for only 1 minute per session before the stimulator was turned off. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 6 years of education and capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
- Consent to actively cooperate in the completion of subsequent follow-up assessments.
Key exclusion criteria (5 listed)
- Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
- A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
- Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
- Severe organic diseases that might compromise study participation.
- Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
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 |
|---|---|---|
| Temporal Interference StimulationThe stimulation duration are 30 minutes per session, administered twice daily for 5 consecutive days. | Device | Temporal Interference Stimulation Group |
| ShameThe stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. Sham stimulation used the same montage and ramp procedures but delivered stimulation for only 1 minute per session before the stimulator was turned off. | Device | Control Group |
Primary outcome
Change of Craving
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.
12 secondary outcomes
Drug Use
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Changes in Reward Learning
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Decision-making Preferences and Delay of Gratification
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
sensitivity to reward and punishment
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
emotional states
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
emotional state
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
sleep quality
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
EEG
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
EEG
Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
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 2 Sep 2026.
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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 study chair
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 Temporal Interference Stimulation 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 4 inclusion and 5 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 2 Sep 2026. 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 (time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment). 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 2 Sep 2026.