Amphetamine Use DisordersNCT06454474
Closed-loop tACS Modulation for the Core Clinical Features of Drug Addiction
A study testing Closed-loop tACS stimulation based on addiction-induced states in people with Amphetamine Use Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes the effect of closed-loop tACS based on brain states 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?
- Closed-loop tACS stimulation based on addiction-induced states
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Jun 2025
- 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 9 years of education or are capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-5 concerning the severity of amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use of 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 tACS, include 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
About this study
Official title: Individualized Neuromodulation Intervention Techniques for the Core Clinical Features of Drug Addiction
Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes the effect of closed-loop tACS based on brain states
Read the detailed description
Methamphetamine use disorder (MUD) addiction represents a severe public health concern. Individuals addicted to methamphetamine exhibit intense cravings and physiological reactions when exposed to addiction-related cues, a phenomenon termed "cue reactivity." Cue reactivity is a critical factor in the development and persistence of addiction. Impairments in inhibitory control are considered a significant factor contributing to the emergence of cue reactivity. Conventional pharmacological and physical interventions suffer from low efficiency and high effect variance. Closed-loop physical interventions, which adjust stimulation parameters in real-time based on brain state, are an innovative approach with the potential to enhance the precision and efficiency of treatments. Closed-loop interventions based on transcranial alternating current stimulation (tACS) hold promise as a novel therapeutic method for treating methamphetamine addiction. This study aims to develop and evaluate the effect of closed-loop tACS on cue reactivity and inhibition control function in MUD. Therefore, the investigators intend to employ the non-invasive tACS technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.
- Conditions
- Amphetamine Use Disorders
- Being tested
- Closed-loop tACS stimulation based on addiction-induced states
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop tACS stimulation based on addiction-induced statesDevice
We conducted a longitudinal controlled study of closed-loop tACS interventions among MA dependents.This involved implementing interventions based on addiction-induced states.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop tACS stimulation based on addiction-induced states | Experimental | In the initial phase of this study, participants will receive individualized closed-loop tACS interventions once daily for five consecutive days. Concurrently, they will be exposed to MA-related cue paradigms to induce cue-reactivity states, while scalp EEG signals are collected. Stimulation will be initiated only upon identifying specific neural signals associated with MA cues. Receives: Device: Closed-loop tACS stimulation based on addiction-induced states |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for craving (VAS-Craving)
The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale for craving (VAS-Craving), where individuals rated their cravings on a scale from 0 to 100, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.
Measured: through study completion, an average of 5 days
Secondary outcomes (2)
Stop-signal task
The stop-signal task can indicate executive control capabilities by measuring Stop-signal reaction time (SSRT), Stop-signal delays (SSD), Go-task reaction time (RT), and Success and failure inhibition rates. A lower SSRT value indicates better inhibitory control.
Measured: through study completion, an average of 5 days
Obsessive Compulsive Drug Use Scale (OCDUS)
The Obsessive Compulsive Drug Use Scale (OCDUS) measures the overall craving level within a period from a multidimensional perspective. The scale consists of 13 items and uses a five-point scoring system, with each item scored on a scale of 1 to 5. The higher the total score, the greater the level of craving.
Measured: through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MIn Zhao, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454474
- Sponsor's protocol ID
- MZhao-016
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Neuromodulation Intervention Techniques for the Core Clinical Features of Drug Addiction
- ClinicalTrials.gov ID
- NCT06454474
- Acronym / sponsor ID
- MZhao-016
- Conditions
- Amphetamine Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Jun 2024 (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.
Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes the effect of closed-loop tACS based on brain states
Detailed description
Methamphetamine use disorder (MUD) addiction represents a severe public health concern. Individuals addicted to methamphetamine exhibit intense cravings and physiological reactions when exposed to addiction-related cues, a phenomenon termed "cue reactivity." Cue reactivity is a critical factor in the development and persistence of addiction. Impairments in inhibitory control are considered a significant factor contributing to the emergence of cue reactivity. Conventional pharmacological and physical interventions suffer from low efficiency and high effect variance. Closed-loop physical interventions, which adjust stimulation parameters in real-time based on brain state, are an innovative approach with the potential to enhance the precision and efficiency of treatments. Closed-loop interventions based on transcranial alternating current stimulation (tACS) hold promise as a novel therapeutic method for treating methamphetamine addiction. This study aims to develop and evaluate the effect of closed-loop tACS on cue reactivity and inhibition control function in MUD. Therefore, the investigators intend to employ the non-invasive tACS technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-loop tACS stimulation based on addiction-induced states | Experimental | Device: Closed-loop tACS stimulation based on addiction-induced statesIn the initial phase of this study, participants will receive individualized closed-loop tACS interventions once daily for five consecutive days. Concurrently, they will be exposed to MA-related cue paradigms to induce cue-reactivity states, while scalp EEG signals are collected. Stimulation will be initiated only upon identifying specific neural signals associated with MA cues. |
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 or are capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-5 concerning the severity of amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use of at least once per week.
- Consent to actively cooperate in the completion of subsequent follow-up assessments.
Key exclusion criteria (4 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 tACS, include 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 |
|---|---|---|
| Closed-loop tACS stimulation based on addiction-induced statesWe conducted a longitudinal controlled study of closed-loop tACS interventions among MA dependents.This involved implementing interventions based on addiction-induced states. | Device | Closed-loop tACS stimulation based on addiction-induced states |
Primary outcome
Visual Analog Scale for craving (VAS-Craving)
Time frame: through study completion, an average of 5 days
The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale for craving (VAS-Craving), where individuals rated their cravings on a scale from 0 to 100, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.
2 secondary outcomes
Stop-signal task
Time frame: through study completion, an average of 5 days
Obsessive Compulsive Drug Use Scale (OCDUS)
Time frame: through study completion, an average of 5 days
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 11 Aug 2026.
- 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.
MIn Zhao 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 Closed-loop tACS stimulation based on addiction-induced states 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 4 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 11 Aug 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. 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?
Visual Analog Scale for craving (VAS-Craving) (time frame: through study completion, an average of 5 days). 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 11 Aug 2026.