TACS Intervention for Methamphetamine Addiction

NCT06288997 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Mental Health Center

Phase

Not applicable

Started

2021-11-21

Last updated

2024-09-19

Condition(s) studied

Methamphetamine Use Disorder

Investigational drug(s) / intervention(s)

Active transcranial alternating current stimulationSham transcranial alternating current stimulation

Active transcranial alternating current stimulation: Hi-tACS with a current level of 15mA with a patented frequency of 77.5Hz.

Sham transcranial alternating current stimulation: 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 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). 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

The inclusion criteria include: 1. ages between 18 and 70; 2. education level of at least primary school; 3. confirmed diagnosis of MUD as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 4. a subjective craving score of 30 or higher; 5. absence of any other behavioral, pharmacological, or physical treatments during the trial. The exclusion criteria include: 1. significant neurological or serious psychiatric disorders; 2. concurrent substance use disorders; 3. previous treatments with electroconvulsive therapy, transcranial magnetic stimulation, or transcranial direct current stimulation; 4. presence of a cochlear implant, cardiac pacemaker, implanted neurological device, or cerebral metal; 5. current pregnancy or lactation; 6. severe withdrawal symptoms; 7. engagement in other clinical studies.

Primary outcome measure(s)

Subjective craving — 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 — 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.

Trial sites (5)

Facility	City	Region
Beijing Tiantanghe Addiction Rehab Center	Beijing	Beijing Municipality
Hubei Shizishan Drug Rehabilitation Center	Wuhan	Hubei
Da Lian Shan Institute of Addiction Rehabilitation	Nanjing	Jiangsu
Tai Hu Institute of Addiction Rehabilitation	Suzhou	Jiangsu
Sichuan Drug Rehabilitation Center	Deyang	Sichuan

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Other trials for the same condition

Cerebellum-Prefrontal Paired-Pulse Stimulation for Methamphetamine Use Disorder Recruiting

Closed-loop TBS Targeting rPO for the Core Clinical Features of the Methamphetamine Use Disorder Starting soon

Closed-loop TMS for the Core Clinical Features of the Methamphetamine Use Disorder Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06288997 on ClinicalTrials.gov ↗ ← All trials in China