Methamphetamine Use DisordertACS for MUDNCT06288997
TACS Intervention for Methamphetamine Addiction
A study testing Active transcranial alternating current stimulation in people with Methamphetamine Use Disorder, run by Shanghai Mental Health Center at 5 sites in China.
Trial summary
In 2021, nearly 296 million people worldwide used psychoactive substances, highlighting a significant need for effective interventions for disorders such as Methamphetamine Use Disorder (MUD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Active transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 5 sitesChina
- Study dates
- 21 Nov 2021to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria include:
- ages between 18 and 70;
- education level of at least primary school;
- confirmed diagnosis of MUD as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- a subjective craving score of 30 or higher;
- absence of any other behavioral, pharmacological, or physical treatments during the trial.
The exclusion criteria include:
- significant neurological or serious psychiatric disorders;
- concurrent substance use disorders;
- previous treatments with electroconvulsive therapy, transcranial magnetic stimulation, or transcranial direct current stimulation;
- presence of a cochlear implant, cardiac pacemaker, implanted neurological device, or cerebral metal;
- current pregnancy or lactation;
- severe withdrawal symptoms;
- engagement in other clinical studies.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Tiantanghe Addiction Rehab Center
Beijing, Beijing Municipality, 100054
Sichuan Drug Rehabilitation Center
Deyang, Sichuan, 618000
Da Lian Shan Institute of Addiction Rehabilitation
Nanjing, Jiangsu, 210000
Tai Hu Institute of Addiction Rehabilitation
Suzhou, Jiangsu, 215000
Hubei Shizishan Drug Rehabilitation Center
Wuhan, Hubei, 430000
About this study
In 2021, nearly 296 million people worldwide used psychoactive substances, highlighting a significant need for effective interventions for disorders such as Methamphetamine Use Disorder (MUD). Despite existing treatments, including behavioral therapies and medications, the relapse rates remain high, signaling the need for more potent and targeted approaches. This clinical trial investigates high-intensity transcranial alternating current stimulation (Hi-tACS), a non-invasive method that applies 15mA electrical currents with a patented frequency of 77.5Hz to modulate brain activity. Hi-tACS has shown promise in preliminary studies for its ability to reduce drug cravings significantly by influencing brain regions crucial in addiction. The primary aim of this study is to evaluate the effectiveness of Hi-tACS in curbing cravings in individuals with MUD. As secondary objectives, the trial will also explore the potential benefits of Hi-tACS in alleviating other clinical symptoms, enhancing cognitive performance, and positively influencing brain activity. This study seeks to establish Hi-tACS as a more effective treatment option that could lead to substantially lower relapse rates for individuals with MUD.
Read the detailed description
The study will be conducted at multiple drug rehabilitation centers in China. The procedure includes screening, pre-intervention evaluation (baseline), a 2-week intervention (twice daily sessions, 40 minutes each, totaling 20 sessions), post-intervention evaluation, and follow-up evaluations at 2 weeks and 3 months.
During the screening phase, participants are recruited and undergo a health interview to determine eligibility. If eligible, participants sign informed consent and are randomly assigned to one of two groups (active or sham).
At baseline, participants report demographic information and complete various questionnaires, cognitive tasks, and electroencephalogram (EEG) recordings to assess craving, clinical symptoms, and cognitive abilities.
During the intervention phase, tACS stimulates the scalp with three Nexalin electrodes (Nexalin Technology, Inc., Houston, TX, USA): electrodes are placed according to the international 10/20 system for EEG recording. A 4.45 × 9.53 cm electrode is placed above the forehead (Fpz, Fp1, and Fp2), and two 3.18 × 3.81 cm electrodes are placed above both mastoid areas. The active group receives 77.5 Hz tACS for 40 minutes per session. The sham group receives treatment with identical technical parameters, which induce scalp sensations but without penetration of the electric field into the brain. After each session, any side effects reported by participants are recorded to ensure safety and feasibility.
Post-intervention evaluation, as well as the 2-week and 3-month follow-up evaluations, mirror the pre-intervention assessments.
Sample size was calculated using GPower 3.1.9.4. Since Hi-tACS has not been previously investigated in drug addiction, an effect size of 0.15 was chosen. The power is set at 80%, and a two-tailed significance level is maintained at 5%. The calculations suggest a total sample size of 62. Considering potential dropout during treatment, the sample size was set at 70 (35 per group).
Throughout the intervention, patients, operators, and raters remain blinded to treatment conditions. To ensure study quality, researchers and drug rehabilitation staff will collaborate throughout the process, and data will be converted to electronic versions after each evaluation.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Active transcranial alternating current stimulation, Sham transcranial alternating current stimulation
- Keywords
- transcranial alternating current stimulation, Methamphetamine use disorder, craving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial alternating current stimulationDevice
Hi-tACS with a current level of 15mA with a patented frequency of 77.5Hz.
Sham transcranial alternating current stimulationDevice
The device for the sham group has the same appearance and technical settings as the one used in the active group, designed to produce similar sensations on the scalp, but without effective penetration of the electric field into the brain.
| Study group | Role | What they receive |
|---|---|---|
| Active tACS group | Active comparator | In the active group, the intervention is carried out using Hi-tACS with an intensive current of 15mA and a frequency of 77.5 Hz. Each intervention session lasts for 40 minutes, with two sessions conducted daily - one in the morning and one in the afternoon. The intervention is spread over a 10-day period, with sessions taking place five days per week, totaling two weeks. Receives: Device: Active transcranial alternating current stimulation |
| Sham tACS group | Sham comparator | The sham group undergoes sessions with the same technical settings, designed to produce similar scalp sensations but without effective penetration of the electric field into the brain. Each session lasts for 40 minutes, with two sessions conducted daily - one in the morning and one in the afternoon. The intervention is spread over a 10-day period, with sessions taking place five days per week, totaling two weeks. Receives: Device: Sham transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective craving
Subjective craving is measured by using Analogue Scale (VAS) for craving after watching video stimulus, ranging from 0 to 100, where 0 indicates no craving at all and 100 represents an extremely intense craving.
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Objective craving
Objective craving is measured by using the EEG recording to reflect the brain activity of individuals to the drug-related videos and pictures. EEG data were recorded when participants watch videos in Video-induced Craving Task (VCT) and when participants see pictures in Picture-induced Craving Task (PCT). The amplitude of late positive potential (LPP) was considered as a major outcome of the drug-cue related ERP, higher LPP is related to higher craving.
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Secondary outcomes (6)
Resting-state brain activity
based on resting-state EEG, the five power oscillations will be calculated (Delta band, Theta band, Alpha band, Beta band, and Gamma band).
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Depression status
The depression status is measured by Beck Depression inventory scale. The questionnaire is a 21-question multiple-choice self-report inventory, score ranged from 0 to 63, high score means worse depression.
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Anxiety status
Anxiety status is measured by Beck anxiety inventory scale,it consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). higher score means worse anxiety.
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Sleep status
Sleep status measured by Pittsburgh Sleep Quality Index scale (PSQI). The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Impulsivity
Impulsivity is measured by Barratt Impulsiveness Scale, the total scores can range from 30 to 120. Higher score means higher impulsivity.
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Uncertainty decision-making
Uncertainty decision-making ability is measured by using choice under risk and ambiguity. The score of probability for uncertainty choice is the major outcome, higher means more inclined to take risks. ERP (event-related potential) is also analyzed during decision-making. Higher amplitude of ERP means more inclined to take risks.
Measured: The day before intervention, the day after intervention, 2 weeks after intervention and 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 posted1 Mar 2024
- Study start21 Nov 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ti-fei Yuan, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288997
- Sponsor's protocol ID
- TFYuan_tACS
- Acronym
- tACS for MUD
- Status last verified
- Sep 2024
- First submitted
- 21 Nov 2023
- Last updated
- 19 Sep 2024
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACS Intervention for Methamphetamine Addiction
- ClinicalTrials.gov ID
- NCT06288997
- Acronym / sponsor ID
- tACS for MUD / TFYuan_tACS
- Conditions
- Methamphetamine Use Disorder
- Keywords
- transcranial alternating current stimulation, Methamphetamine use disorder, craving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Mar 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.
In 2021, nearly 296 million people worldwide used psychoactive substances, highlighting a significant need for effective interventions for disorders such as Methamphetamine Use Disorder (MUD). Despite existing treatments, including behavioral therapies and medications, the relapse rates remain high, signaling the need for more potent and targeted approaches. This clinical trial investigates high-intensity transcranial alternating current stimulation (Hi-tACS), a non-invasive method that applies 15mA electrical currents with a patented frequency of 77.5Hz to modulate brain activity. Hi-tACS has shown promise in preliminary studies for its ability to reduce drug cravings significantly by influencing brain regions crucial in addiction. The primary aim of this study is to evaluate the effectiveness of Hi-tACS in curbing cravings in individuals with MUD. As secondary objectives, the trial will also explore the potential benefits of Hi-tACS in alleviating other clinical symptoms, enhancing cognitive performance, and positively influencing brain activity. This study seeks to establish Hi-tACS as a more effective treatment option that could lead to substantially lower relapse rates for individuals with MUD.
Detailed description
The study will be conducted at multiple drug rehabilitation centers in China. The procedure includes screening, pre-intervention evaluation (baseline), a 2-week intervention (twice daily sessions, 40 minutes each, totaling 20 sessions), post-intervention evaluation, and follow-up evaluations at 2 weeks and 3 months.
During the screening phase, participants are recruited and undergo a health interview to determine eligibility. If eligible, participants sign informed consent and are randomly assigned to one of two groups (active or sham).
At baseline, participants report demographic information and complete various questionnaires, cognitive tasks, and electroencephalogram (EEG) recordings to assess craving, clinical symptoms, and cognitive abilities.
During the intervention phase, tACS stimulates the scalp with three Nexalin electrodes (Nexalin Technology, Inc., Houston, TX, USA): electrodes are placed according to the international 10/20 system for EEG recording. A 4.45 × 9.53 cm electrode is placed above the forehead (Fpz, Fp1, and Fp2), and two 3.18 × 3.81 cm electrodes are placed above both mastoid areas. The active group receives 77.5 Hz tACS for 40 minutes per session. The sham group receives treatment with identical technical parameters, which induce scalp sensations but without penetration of the electric field into the brain. After each session, any side effects reported by participants are recorded to ensure safety and feasibility.
Post-intervention evaluation, as well as the 2-week and 3-month follow-up evaluations, mirror the pre-intervention assessments.
Sample size was calculated using GPower 3.1.9.4. Since Hi-tACS has not been previously investigated in drug addiction, an effect size of 0.15 was chosen. The power is set at 80%, and a two-tailed significance level is maintained at 5%. The calculations suggest a total sample size of 62. Considering potential dropout during treatment, the sample size was set at 70 (35 per group).
Throughout the intervention, patients, operators, and raters remain blinded to treatment conditions. To ensure study quality, researchers and drug rehabilitation staff will collaborate throughout the process, and data will be converted to electronic versions after each evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS group | Active comparator | Device: Active transcranial alternating current stimulationIn the active group, the intervention is carried out using Hi-tACS with an intensive current of 15mA and a frequency of 77.5 Hz. Each intervention session lasts for 40 minutes, with two sessions conducted daily - one in the morning and one in the afternoon. The intervention is spread over a 10-day period, with sessions taking place five days per week, totaling two weeks. |
| Sham tACS group | Sham comparator | Device: Sham transcranial alternating current stimulationThe sham group undergoes sessions with the same technical settings, designed to produce similar scalp sensations but without effective penetration of the electric field into the brain. Each session lasts for 40 minutes, with two sessions conducted daily - one in the morning and one in the afternoon. The intervention is spread over a 10-day period, with sessions taking place five days per week, totaling two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Active transcranial alternating current stimulationHi-tACS with a current level of 15mA with a patented frequency of 77.5Hz. | Device | Active tACS group |
| Sham transcranial alternating current stimulationThe device for the sham group has the same appearance and technical settings as the one used in the active group, designed to produce similar sensations on the scalp, but without effective penetration of the electric field into the brain. | Device | Sham tACS group |
Primary outcome
Subjective craving
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Subjective craving is measured by using Analogue Scale (VAS) for craving after watching video stimulus, ranging from 0 to 100, where 0 indicates no craving at all and 100 represents an extremely intense craving.
Objective craving
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Objective craving is measured by using the EEG recording to reflect the brain activity of individuals to the drug-related videos and pictures. EEG data were recorded when participants watch videos in Video-induced Craving Task (VCT) and when participants see pictures in Picture-induced Craving Task (PCT). The amplitude of late positive potential (LPP) was considered as a major outcome of the drug-cue related ERP, higher LPP is related to higher craving.
6 secondary outcomes
Resting-state brain activity
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Depression status
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Anxiety status
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Sleep status
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Impulsivity
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Uncertainty decision-making
Time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Ti-fei Yuan, PhD principal investigator
Shanghai Mental Health Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial alternating current stimulation in people with Methamphetamine Use Disorder, run by Shanghai Mental Health Center at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
Subjective craving (time frame: The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.). The study lists 2 primary outcomes in all. 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 19 Sep 2024.