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Methamphetamine AbuseNCT06292156

tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

A study testing Theta treatment group in people with Methamphetamine Abuse, run by Beijing HuiLongGuan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. To evaluate the cognitive function of methamphetamine Patients. 2. Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology; 3. The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Methamphetamine Abuse
What is being tested?
Theta treatment group
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteChina
Study dates
30 Dec 2023to 30 Dec 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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Clinical diagnosis diagnosis of methamphetamine use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • None of participants had mixed use of other drugs
  • None of participants had physical disability
  • None of participants had acute physical or mental illness, hallucinations, acute withdrawal symptoms
  • None of participants were receiving any medical treatment

Who cannot join

  • Intracranial hypertension
  • Cranial defects
  • Tumors
  • Serious physical illnesses (e.g., cardiovascular, liver, kidney, gastrointestinal disorders)
  • Infectious diseases
  • Immune system disorders

Trial locations and contacts

1 site in 1 country.

China1 site
  • Xin Hua Drug Rehabilitation Center

    Mianyang

Other trials in China

About this study

  1. To evaluate the cognitive function of methamphetamine Patients.
  2. Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology;
  3. The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine patients
Being tested
Theta treatment group, Sham control group
Keywords
Methamphetamine patients, Cognitive impairments, tACS
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Theta treatment groupDevice

    The target 'active' electrode was placed over the MFC and the second 'return' electrode was placed over the medial parietal cortex. 6 Hz stimulation was used and a alternating current of 2mA was applied for 30min each day(Monday-Friday) for 3consecutive weeks

  • Sham control groupDevice

    Sham stimulation lasted 30 s (15 s of ramp- up and 15 s of ramp-down).

Study groups in NCT06292156
Study groupRoleWhat they receive
Theta treatment groupExperimentalIn active tACS, the target 'active' electrode was placed over the MFC and the second 'return' electrode was placed over the medial parietal cortex. 6 Hz stimulation was used and a alternating current of 2mA was applied for 30min each day(Monday-Friday) for 3 consecutive weeks.
Receives: Device: Theta treatment group
Sham control groupSham comparatorIn sham group, Sham stimulation lasted 30 s (15 s of ramp- up and 15 of ramp-down) .
Receives: Device: Sham control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which contains 12 subtests for calculating the index scores of delayed memory (including list recall, story recall, figure recall, and list recognition tests), attention (including digit span and coding tests), language (including picture naming and semantic fluency tests), visuospatial/constructional index (including figure copy and line orientation tasks), immediate memory (including list learning and story memory tasks), and global neuropsychological function.

    Measured: Baseline, week 3

  2. ERP components associated with cognitive function

    Investigate the ERP components associated with cognitive function of methamphetamine patients using event-related potential analysis

    Measured: Baseline, week 3

  3. Condition stop signal task

    Condition stop signal task was used to assess cognitive control function, including proactive control and reactive control.

    Measured: Baseline, week 3

  4. Neural oscillations associated with cognitive function

    Investigate the neural oscillations associated with cognitive function of methamphetamine patients using time-frequency analysis.

    Measured: Baseline, week 3

  5. Functional connection of brain region associated with cognitive function

    Investigate the functional connection of brain region associated with cognitive function of methamphetamine patients using functional connection analysis

    Measured: Baseline, week 3

  6. Microstate associated with cognitive function

    Investigate the microstate associated with cognitive function of methamphetamine patients using microstate analysis

    Measured: Baseline, week 3

  7. Neural Dynamic Coding of brain region associated with cognitive function

    Investigate the functional connection of brain region associated with cognitive function of methamphetamine patients using multivariate pattern analysis

    Measured: baseline, week 3

  8. The effect of oxidative stress system on cognitive function

    The investigators examined markers of oxidative stress related to cognitive function using bioassay.

    Measured: Baseline, week 3

  9. The effect of immune system on cognitive function

    The investigators immune indicators related to cognitive function using bioassay.

    Measured: Baseline, week 3

  10. The effect of brain derived neurotrophic factor(BDNF) on cognitive function

    The investigators BDNF indicators related to cognitive function using bioassay.

    Measured: Baseline, week 3

  11. Genetic mechanism of cognitive function

    The investigators performed comprehensive genetic testing to explore the genetic mechanism of cognitive function.

    Measured: Baseline, week 3

Secondary outcomes (16)
  1. Reverse learning task

    Reverse learning task was used to access the compulsive drug using behavior of methamphetamine patients.

    Measured: Baseline, week 3

  2. Beck Depression Scale

    Beck Depression Scale was used to access degree of depression.The total score varies between 0 and 30 points, with higher scores indicating higher levels of depression.

    Measured: Baseline, week 3

  3. Barrett impulse Scale

    The scale includes three dimensions: motor impulsivity, cognitive impulsivity and unplanned impulsivity. The total score varies between 30 and 150 points, with higher scores indicating higher levels of impulsivity. High scores on the three subscales indicated hyperactivity, inattention, and lack of planning, respectively.

    Measured: Baseline, week 3

  4. Degree of insomnia

    Insomnia Severity Index was used acess the patient's insomnia.The total score varies between 0 and 28 points, with higher scores indicating higher levels of insomnia.

    Measured: Baseline, week 3

  5. The Sensitivity to Punishment and Reward Questionnaire

    The Sensitivity to Punishment and Reward Questionnaire including penalty sensitivity factor and reward sensitivity factor. The total score varies between 0 and 31 points, with higher scores indicating higher sensitivity to penalty and reward.

    Measured: Baseline, week 3

  6. Visual analog scale

    Visual analog scale(VAS) was used to acess the craving of drug on a scale of 1 to 10.A higher score indicates a higher desire for the drug

    Measured: Baseline, week 3

  7. The Desires for Drug Questionnaire

    The Desires for Drug Questionnaire (DDQ) was used to access the craving of drug, which measures three factors, including desire and intention, negative reinforcement, and control. Higher scores of drug desire and negative reinforcement indicated higher drug craving, and higher scores of control indicated better drug craving control ability.The total score on the table is equal to the sum of the scores in the three dimensions, ranging from 3 to 21 points.

    Measured: Baseline, week 3

  8. Obsessive compulsive drug use scale

    The Obsessive Compulsive Drug Use Scale (OCDUS) also measures three factors: thoughts about methamphetamine and interference, desire and control, and resistance to thoughts and intention.The higher the total score, the higher the craving. The total score varies between 13 and 65 points, with higher scores indicating higher craving.

    Measured: Baseline, week 3

  9. Obsessive-compulsive inventory

    Obsessive-compulsive inventory was evaluated the subjects' obsessive-compulsive symptoms from 6 different dimensions, including washing, forcing thoughts, storing, sorting, checking, mixing.The total score varies between 0 and 72 points, with higher scores indicating more severe obsessive-compulsive symptoms.

    Measured: Baseline, week 3

  10. Thought Control Ability Questionnaire

    Thought Control Ability Questionnaire was used to measure the ability of an individual to control unwanted and intrusive thoughts. The total score varies between 25 and 125 points, with higher indicating scores the stronger the thought control ability.

    Measured: Baseline, week 3

  11. Thought Suppression Questionnaire

    Thought Suppression Questionnaire were used to access the thought control ability. The total score varies between 15 and 75 points, with higher indicating scores the stronger the thought suppression ability.

    Measured: Baseline, week 3

  12. Rumination Questionnaire

    Rumination Questionnaire was used to access ruminate behavior.A higher total score indicates a higher tendency to ruminate. The total score varies between 22 and 88 points, with higher scores indicating higher tendency to ruminate.

    Measured: Baseline, week 3

  13. Anger Rumination Questionnaire

    Anger Rumination Questionnaire was used to access anger ruminate behavior. The total score varies between 19 and 76 points, with higher scores indicating higher tendency to anger ruminate.

    Measured: Baseline, week 3

  14. Beck Anxiety Scale

    Beck Anxiety Scale was used to access degree of anxiety.The total score varies between 0 and 63 points, with higher scores indicating higher levels of anxiety.

    Measured: Baseline, week 3

  15. Emotional Regulation Difficulty Scale

    Emotional Regulation Difficulty Scale was used to access the emotional regulation ability of methamphetamine patients.The total score varies between 36 and 180 points, with higher scores indicating the more serious the difficulty in emotion regulation and the lower the level of emotion regulation ability.

    Measured: Baseline, week 3

  16. Aggressive questionnair

    Aggressive questionnaire was used to access aggressive behavior of methamphetamine patients. The total score varies between 30 and 150 points, with higher scores indicating the more aggressive behavior.

    Measured: Baseline, week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start30 Dec 2023
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06292156
Sponsor's protocol ID
CASPsy7
Status last verified
Dec 2025
First submitted
3 Dec 2023
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be avaliable on request

Questions about this trial

What is this clinical trial studying?

A study testing Theta treatment group in people with Methamphetamine Abuse, run by Beijing HuiLongGuan Hospital 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 5 inclusion and 6 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 19 Dec 2025. 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?

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (time frame: Baseline, week 3). The study lists 11 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 Dec 2025.

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