Amphetamine Use DisordersNCT07802223
Closed-loop tTIS Targeted of the Nac 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
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control. 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 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. Contact the study team or a site near you to ask about taking part.
Tianzhen Chen, PhD contact
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Min Zhao, Phd, 18017311005 ext. 64387250, drminzhao@smhc.org.cn
About this study
Official title: Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control. Stimulation will be delivered in real time according to each patient's cue-induced response time.
Read the detailed description
This project will recruit individuals with methamphetamine use disorder. Participants will receive closed-loop transcranial temporal interference stimulation targeting the nucleus accumbens once daily for five consecutive days. During each intervention session, participants will be exposed to methamphetamine-related cues, and stimulation will be triggered according to their response time.
Before and after the intervention, clinical questionnaires and behavioral tasks will be administered to evaluate changes in drug craving, methamphetamine-use-related symptoms, inhibitory control, and reward-related decision-making. Cue-induced neural responses will also be assessed to investigate the neural mechanisms through which closed-loop tTIS targeting the nucleus accumbens may alleviate craving and improve addiction-related cognitive and behavioral dysfunction.
- 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
Each session will comprise 240 trials, during which stimulation may be triggered up to 10 times according to the participant's cue-reactivity state. Each stimulation will consist of a 5-s current ramp-up, 30 s of continuous stimulation, and a 5-s current ramp-down. The intervention will be administered once daily for five consecutive days.
ShameDevice
The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. However, the sham stimulation mode is activated on the device, resulting in consist of a 5-s current ramp-up, but 0 s of continuous stimulation during the stimulation.
| 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. However, the sham stimulation mode is activated on the device, resulting in no actual current being delivered during the stimulation. 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, 1 month after treatment
Secondary outcomes (13)
Obsessive-Compulsive Drug Use Scale score
Drug-related obsessive thoughts and compulsive behaviours will be assessed using the Obsessive-Compulsive Drug Use Scale (OCDUS). The scale consists of 14 items rated from 0 to 4, producing a total score ranging from 0 to 56. Higher scores indicate more severe drug-related obsessive thoughts, craving, and impaired control over drug use.
Measured: baseline, 1 day after treatment, 1 month after treatment
Dual-Mode of Self-Control Scale-Impulsive System score
Impulsive tendencies will be assessed using the Impulsive System subscale of the Dual-Mode of Self-Control Scale (DMSC-S). The subscale contains 12 items rated from 1 to 5, producing a total score ranging from 12 to 60. Higher scores indicate stronger impulsive-system tendencies, including greater impulsivity, distractibility, and preference for immediate gratification.
Measured: baseline, 1 day after treatment, 1 month after treatment
Dual-Mode of Self-Control Scale-Control System score
Self-control will be assessed using the Control System subscale of the Dual-Mode of Self-Control Scale (DMSC-S). The subscale contains 9 items rated from 1 to 5, producing a total score ranging from 9 to 45. Higher scores indicate stronger self-control, including better problem-solving and future-oriented planning.
Measured: baseline, 1 day after treatment, 1 month after treatment
Stop Single Task
Response inhibition will be assessed using the Stop-Signal Task. The primary behavioural parameter will be the reaction time and accuracy, measured in milliseconds. A longer stop-signal reaction time indicates poorer inhibitory control, whereas a shorter stop-signal reaction time indicates better inhibitory control.
Measured: baseline, 1 day after treatment, 1 month after treatment
EEG ERP amplitude during the Stop-Signal Task
The mean amplitude of the stop-related event-related potential and functional connection will be measured in microvolts over frontocentral electrodes within the prespecified post-stimulus time window.
Measured: baseline, 1 day after treatment, 1 month after treatment
Decision-making Preferences and Delay of Gratification
delay discounting task,Delay of gratification will be assessed using a computerised delay-discounting task in which participants choose between smaller immediate rewards and larger delayed rewards. The discounting-rate parameter, k, will be estimated from participants' choices. A higher k value indicates steeper delay discounting, a stronger preference for immediate rewards, and a lower ability to delay gratification.
Measured: baseline, 1 day after treatment, 1 month after treatment
Changes in Reward Learning
Reward learning will be assessed using a computerised reinforcement-learning task. A computational reinforcement-learning model will be fitted to participants' trial-by-trial choices. The learning-rate parameter, alpha, ranges from 0 to 1 and represents the extent to which recent feedback is used to update expected values. Higher values indicate greater updating in response to recent feedback.
Measured: baseline, 1 day after treatment, 1 month after treatment
sensitivity to reward and punishment
Sensitivity to punishment will be assessed using the Sensitivity to Punishment subscale of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ). The subscale contains 24 dichotomous items scored 0 or 1, producing a score ranging from 0 to 24. Higher scores indicate greater sensitivity to punishment.
Measured: baseline, 1 day after treatment, 1 month after treatment
Behavioral Inhibition/Activation System Scale
Sensitivity to anticipated punishment will be assessed using the 7-item Behavioural Inhibition System subscale of the Behavioural Inhibition System/Behavioural Activation System Scales. Each item is rated from 1 to 4, producing a score ranging from 7 to 28. Higher scores indicate greater behavioural inhibition and sensitivity to anticipated punishment.
Measured: baseline, 1 day after treatment, 1 month after treatment
Beck Depression Inventory-II score
Depressive symptom severity will be assessed using the Beck Depression Inventory-II (BDI-II). The inventory consists of 21 items rated from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate more severe depressive symptoms.
Measured: baseline, 1 day after treatment, 1 month after treatment
Drug-cue Flanker task
Attentional interference from methamphetamine-related cues will be assessed using a computerised drug-cue Flanker task. The drug-cue attentional interference effect will be calculated as the difference in mean reaction time between trials containing methamphetamine-related cues and trials containing neutral cues, measured in milliseconds. A larger positive value indicates greater attentional interference from methamphetamine-related cues.
Measured: baseline, 1 day after treatment, 1 month after treatment
EEG theta power
Theta-band power will be quantified within the prespecified frequency range, electrode region, and post-stimulus time window. The cue-related theta effect will be calculated as the difference between methamphetamine-related and neutral cue conditions. A larger value indicates a stronger theta-band response to methamphetamine-related cues.
Measured: baseline, 1 day after treatment, 1 month after treatment
EEG P3 amplitude
Task-related electroencephalography will be recorded during the drug-cue Flanker task and the reward learning task. The mean amplitude of the P3 event-related potential will be measured in microvolts within the prespecified electrode region and post-stimulus time window. A larger positive difference indicates greater neural reactivity to methamphetamine-related cues.
Measured: baseline, 1 day after treatment, 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
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
- 50 participants (estimated)
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
- NCT07802223
- Sponsor's protocol ID
- MZhao-029
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 3 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients
- ClinicalTrials.gov ID
- NCT07802223
- Acronym / sponsor ID
- MZhao-029
- Conditions
- Amphetamine Use Disorders
- Keywords
- Amphetamine-type stimulants, temporal interference stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Sep 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.
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control. Stimulation will be delivered in real time according to each patient's cue-induced response time.
Detailed description
This project will recruit individuals with methamphetamine use disorder. Participants will receive closed-loop transcranial temporal interference stimulation targeting the nucleus accumbens once daily for five consecutive days. During each intervention session, participants will be exposed to methamphetamine-related cues, and stimulation will be triggered according to their response time.
Before and after the intervention, clinical questionnaires and behavioral tasks will be administered to evaluate changes in drug craving, methamphetamine-use-related symptoms, inhibitory control, and reward-related decision-making. Cue-induced neural responses will also be assessed to investigate the neural mechanisms through which closed-loop tTIS targeting the nucleus accumbens may alleviate craving and improve addiction-related cognitive and behavioral dysfunction.
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. However, the sham stimulation mode is activated on the device, resulting in no actual current being delivered during the stimulation. |
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 9 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 StimulationEach session will comprise 240 trials, during which stimulation may be triggered up to 10 times according to the participant's cue-reactivity state. Each stimulation will consist of a 5-s current ramp-up, 30 s of continuous stimulation, and a 5-s current ramp-down. The intervention will be administered once daily for five consecutive days. | Device | Temporal Interference Stimulation Group |
| ShameThe stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. However, the sham stimulation mode is activated on the device, resulting in consist of a 5-s current ramp-up, but 0 s of continuous stimulation during the stimulation. | Device | Control Group |
Primary outcome
Change of Craving
Time frame: baseline, 1 day after treatment, 1 month after treatment
Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.
13 secondary outcomes
Obsessive-Compulsive Drug Use Scale score
Time frame: baseline, 1 day after treatment, 1 month after treatment
Dual-Mode of Self-Control Scale-Impulsive System score
Time frame: baseline, 1 day after treatment, 1 month after treatment
Dual-Mode of Self-Control Scale-Control System score
Time frame: baseline, 1 day after treatment, 1 month after treatment
Stop Single Task
Time frame: baseline, 1 day after treatment, 1 month after treatment
EEG ERP amplitude during the Stop-Signal Task
Time frame: baseline, 1 day after treatment, 1 month after treatment
Decision-making Preferences and Delay of Gratification
Time frame: baseline, 1 day after treatment, 1 month after treatment
Changes in Reward Learning
Time frame: baseline, 1 day after treatment, 1 month after treatment
sensitivity to reward and punishment
Time frame: baseline, 1 day after treatment, 1 month after treatment
Behavioral Inhibition/Activation System Scale
Time frame: baseline, 1 day after treatment, 1 month after treatment
Beck Depression Inventory-II score
Time frame: baseline, 1 day after treatment, 1 month after treatment
Drug-cue Flanker task
Time frame: baseline, 1 day after treatment, 1 month after treatment
EEG theta power
Time frame: baseline, 1 day after treatment, 1 month after treatment
EEG P3 amplitude
Time frame: baseline, 1 day after treatment, 1 month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
Tianzhen Chen, PhD contact
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: opening soon, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Zhao, PhD (64387250, drminzhao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Craving (time frame: baseline, 1 day after treatment, 1 month 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 3 Sep 2026.