NCT04264741

Transcranial Magnetic Stimulation for Methadone Maintenance Therapy Combined With Methamphetamine Abuse

Transcranial Magnetic Stimulation for Treating Patients Under Methadone Maintenance Therapy Combined With Methamphetamine Abuse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Repetitive transcranial magnetic stimulation (rTMS) has been used to treat opioid and methamphetamine addiction in previous studies, while no evidence was proved for patients methadone maintenance therapy with methamphetamine abuse. The aim of this study is to evaluating the effectiveness and safety of rTMS treatment for methamphetamine abuse in patients with methadone maintenance therapy.

Detailed description

First, a multicenter, double-blind, randomized control study is going to be carried out. 60 recruited patients will be randomized assigned to the intervention group (40) and the control group (20), receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 16-week urine drug test (1 time per week, 4 weeks before rTMS, 4 weeks during rTMS and 8 weeks after rTMS). Self-report methamphetamine use or urine test is set as primary outcome. Cognitive function and craving are also evaluated before and after the intervention. Functional magnetic resonance imaging (fMRI) is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for methadone maintenance therapy with methamphetamine abuse and decrease risk of relapse for both the patients and their families.

Conditions

• Methamphetamine Abuse

Interventions

Type	Name	Description
DEVICE	repetitive transcranial magnetic stimulation (rTMS)	The iTBS group received 900 pulses per day: 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz), 2 s on and 8 s off for 5 min, at 100% resting motor threshold (rMT), over the left DLPFC (F3, EEG system) (4 weeks, 20 daily sessions). A figure-8-shaped Cool-B70 stimulation coil from MagPro X100 device (MagVenture, Farum, Denmark) was used for accurately targeted stimulation. Motor threshold was determined over the left motor cortex, by finding the lowest intensity that produced a motor response in the right abductor pollicis brevis muscles (APB), which produced five motor-evoked potentials responses of at least 50 uV in 10 trials.
DEVICE	sham repetitive transcranial magnetic stimulation (rTMS)	The sham iTBS group received sham stimulation over the left DLPFC (F3, EEG system) (4 weeks, 20 daily sessions). A figure-8-shaped sham Cool-B70 stimulation coil from MagPro X100 device (MagVenture, Farum, Denmark) was used for accurately targeted stimulation. Motor threshold was determined over the left motor cortex, by finding the lowest intensity that produced a motor response in the right abductor pollicis brevis muscles (APB), which produced five motor-evoked potentials responses of at least 50 uV in 10 trials.

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2020-02-11
• Last updated: 2026-03-02

Locations

1 site across 1 country: China