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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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 mV in 10 trials.
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 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 mV in 10 trials.
Wuhan Mental Health Center
Wuhan, China
Self-report drug use and urine test
Patients will be asked to report their drug use for 16 weeks every day and do urine tests once a week for 16 weeks. Loss of visit or rejecting to report or rejecting to do urine tests will be treated as drug use positive (relapse).
Time frame: 16 weeks
Change of Craving assessed by Visual Analog Scale
Evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
Time frame: 12 weeks
Cognitive function assessed by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Evaluate all participants' cognitive function by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Chinese version
Time frame: 12 weeks
Functional magnetic resonance imaging
Functional magnetic resonance imaging is collected once before and once after intervention, mainly collecting structural images, resting state, and task-based fMRI
Time frame: 4 weeks
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