TACS Intervention for Methamphetamine Addiction

NCT06288997 | Active Not Recruiting

• 1 other identifier: TFYuan_tACS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Methamphetamine Use Disorder

Keywords

transcranial alternating current stimulation; Methamphetamine use disorder; craving

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.

Secondary Outcomes (6)

• Resting-state brain activity

  The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.

• Depression status

  The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.

• Anxiety status

  The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.

• Sleep status

  The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.

• Impulsivity

  The day before intervention, the day after intervention, 2 weeks after intervention and 3 months after intervention.

Other Outcomes (1)

• side effect measurements

  every day after each intervention time for the 2 weeks intervention time period

Study Arms (2)

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.

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.

Device: Sham transcranial alternating current stimulation

Interventions

Active transcranial alternating current stimulation DEVICE

Hi-tACS with a current level of 15mA with a patented frequency of 77.5Hz.

Active tACS group

Sham transcranial alternating current stimulation DEVICE

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.

Sham tACS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (5)

Beijing Tiantanghe Addiction Rehab Center

Beijing, Beijing Municipality, 100054, China

Location

Hubei Shizishan Drug Rehabilitation Center

Wuhan, Hubei, 430000, China

Location

Da Lian Shan Institute of Addiction Rehabilitation

Nanjing, Jiangsu, 210000, China

Location

Tai Hu Institute of Addiction Rehabilitation

Suzhou, Jiangsu, 215000, China

Location

Sichuan Drug Rehabilitation Center

Deyang, Sichuan, 618000, China

Location

Study Officials

• Ti-fei Yuan, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: March 1, 2024
• Study Start: November 21, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within twelve months after the trial complete
• Access Criteria: share to health care personnel, patients and the general public.

Locations

CN (5)