Amphetamine Use DisordersNCT06165198
Individualized Neuromodulation 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 closed-loop tACS based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop tACS methods. 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
- 9 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2023to 25 Sep 2024
- 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 capable of effectively cooperating in questionnaire and behavioral task 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 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 tACS, 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 Municipality, 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 closed-loop tACS based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop tACS methods.
Read the detailed description
The current study delineates a robust correlation between prefrontal cortex EEG signals and the psychological craving associated with methamphetamine usage. Dependents exhibit heightened β oscillation energy in the MPFC region and diminished γ oscillation energy across the DLPFC-MPFC region. Previously, through the implementation of rTMS interventions on the left DLPFC, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the MPFC region. This indicates that both β and γ oscillation energies are instrumental in representing the involvement of MPFC and DLPFC during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. Furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when MA dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. Therefore, the investigators intend to employ the non-invasive transcranial alternating current stimulation (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
- Keywords
- individualized therapy, closed-loop, Amphetamine-type stimulants, tACS
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 will conduct a crossover study of closed-loop tACS interventions among participants with methamphetamine use disorder. Participants will receive three single-session EEG-triggered closed-loop tACS interventions at frequencies previously reported to improve cognitive control, administered in a counterbalanced within-subject order. After the optimal frequency is identified based on the predefined neurobehavioral outcomes, participants will receive two additional conditions at the same frequency: random-time stimulation and open-loop continuous stimulation. All five stimulation sessions will be separated by a 5-day interval.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop tACS stimulation based on addiction-induced states | Experimental | Participants will receive closed-loop tACS interventions at different frequencies, with a 5-day interval between sessions. During each session, participants will be exposed to MA-related cue paradigms to induce cue-reactivity states, while scalp EEG signals are collected. Stimulation will be triggered only when specific EEG signals associated with MA cues are identified. The optimal frequency will be determined at the group level based on prespecified cue-reactivity EEG and inhibitory-control outcomes. Subsequently, participants will receive two additional control conditions at the identified optimal frequency: random-time stimulation, which will deliver the same number of stimulation events at pseudorandom time points independently of the EEG-defined brain state, and open-loop continuous stimulation, which will deliver an equivalent total stimulation dose continuously. 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.
Stop-signal reaction time (SSRT) from the stop-signal task
The stop-signal task can indicate executive control capabilities by measuring Stop-signal reaction time. A shorter SSRT indicates better inhibitory functions.
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
Changes of electroencephalogram power spectrum
Resting-state EEG can be used to extract power spectra and electrode functional connectivity; on-task EEG can be used to isolate time-frequency features during non-stimulated trials to extract alpha, beta, theta, and gamma band energy of the parietal and occipital electrodes. Both can be used to assess changes in neural activity before, during, and after their restimulation.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start25 Sep 2023
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT06165198
- Sponsor's protocol ID
- MZhao-013
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 14 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 14 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
- NCT06165198
- Acronym / sponsor ID
- MZhao-013
- Conditions
- Amphetamine Use Disorders
- Keywords
- individualized therapy, closed-loop, Amphetamine-type stimulants, tACS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 11 Dec 2023 (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 closed-loop tACS based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop tACS methods.
Detailed description
The current study delineates a robust correlation between prefrontal cortex EEG signals and the psychological craving associated with methamphetamine usage. Dependents exhibit heightened β oscillation energy in the MPFC region and diminished γ oscillation energy across the DLPFC-MPFC region. Previously, through the implementation of rTMS interventions on the left DLPFC, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the MPFC region. This indicates that both β and γ oscillation energies are instrumental in representing the involvement of MPFC and DLPFC during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. Furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when MA dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. Therefore, the investigators intend to employ the non-invasive transcranial alternating current stimulation (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
- Device feasibility
- 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 statesParticipants will receive closed-loop tACS interventions at different frequencies, with a 5-day interval between sessions. During each session, participants will be exposed to MA-related cue paradigms to induce cue-reactivity states, while scalp EEG signals are collected. Stimulation will be triggered only when specific EEG signals associated with MA cues are identified. The optimal frequency will be determined at the group level based on prespecified cue-reactivity EEG and inhibitory-control outcomes. Subsequently, participants will receive two additional control conditions at the identified optimal frequency: random-time stimulation, which will deliver the same number of stimulation events at pseudorandom time points independently of the EEG-defined brain state, and open-loop continuous stimulation, which will deliver an equivalent total stimulation dose continuously. |
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 capable of effectively cooperating in questionnaire and behavioral task 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 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 tACS, 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 |
|---|---|---|
| Closed-loop tACS stimulation based on addiction-induced statesWe will conduct a crossover study of closed-loop tACS interventions among participants with methamphetamine use disorder. Participants will receive three single-session EEG-triggered closed-loop tACS interventions at frequencies previously reported to improve cognitive control, administered in a counterbalanced within-subject order. After the optimal frequency is identified based on the predefined neurobehavioral outcomes, participants will receive two additional conditions at the same frequency: random-time stimulation and open-loop continuous stimulation. All five stimulation sessions will be separated by a 5-day interval. | Device | Closed-loop tACS stimulation based on addiction-induced states |
Primary outcome
Stop-signal reaction time (SSRT) from the stop-signal task
Time frame: Through study completion, an average of 1 month
The stop-signal task can indicate executive control capabilities by measuring Stop-signal reaction time. A shorter SSRT indicates better inhibitory functions.
1 secondary outcome
Changes of electroencephalogram power spectrum
Time frame: Through study completion, an average of 1 month
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 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Amphetamine Use Disorders
Not yet recruiting
Closed-loop tTIS Targeted of the Nac as an Intervention for MUD Patients
Amphetamine Use Disorders
RecruitingPhase 2
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
Post Traumatic Stress Disorder
Not yet recruitingPhase 2
Psilocybin Therapy for Methamphetamine Use Disorder and HIV
Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV)
Recruiting
Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness
Opioid Use Disorder, Severe, Amphetamine Use Disorder
RecruitingEarly Phase 1
[C-11]NPA PET-amphetamine in Cocaine Use Disorders
Cocaine Use Disorder
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 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 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 14 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?
Stop-signal reaction time (SSRT) from the stop-signal task (time frame: Through study completion, an average of 1 month). 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 14 Aug 2026.