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Completed

NCT Number: NCT06454474

Closed-loop tACS Modulation 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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai, Shanghai, China, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Closed-loop tACS stimulation based on addiction-induced states

Device

We conducted a longitudinal controlled study of closed-loop tACS interventions among MA dependents.This involved implementing interventions based on addiction-induced states.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Stop-signal task

    Time frame: through study completion, an average of 5 days

    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.

  2. Obsessive Compulsive Drug Use Scale (OCDUS)

    Time frame: through study completion, an average of 5 days

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Individualized Neuromodulation Intervention Techniques for the Core Clinical Features of Drug Addiction

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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