Methamphetamine Abuse
Conditions
Keywords
repetitive transcranial magnetic stimulation (rTMS), methamphetamine abuse, methadone maintenance therapy, urine test, relapse
Brief 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.
Interventions
DEVICErepetitive 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.
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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* aged 18-65 years * a diagnosis of OUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and current enrollment in MMT * a diagnosis of methamphetamine (MA) use disorder according to the DSM-5 * four or more positive methamphetamine urine tests within a 4-week period * no concurrent medication treatment except for methadone * an education level of junior high school or higher * normal vision and hearing
Exclusion criteria
* severe physical or neurological conditions requiring active treatment (e.g., stroke, seizure, or traumatic brain injury) * use of cognition-enhancing medications within the past 6 months * other substance use disorders (excluding nicotine dependence) in recent five years * comorbid severe psychiatric disorders (e.g., bipolar disorder, schizophrenia, or major depressive disorder) * pregnancy or lactation among female participants * contraindications for iTBS, such as implanted devices (e.g., pacemakers, cochlear implants, neurostimulators) or intraocular metal fragments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-report drug use and urine test | 16 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function assessed by RBANS | 4 weeks | Cognitive function was assessed using the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS was administered at baseline and after the 4-week intervention. The battery includes 12 subtests that generate index scores for immediate memory, visuospatial/constructional function, language, attention, and delayed memory, as well as a Total Scale Score. Higher scores indicate better cognitive performance. The RBANS Total Scale Score was defined as the summary cognitive outcome, and the five index scores were used to characterize domain-specific cognitive changes. |
| Magnetic resonance imaging | 4 weeks | Magnetic resonance imaging is collected once before and once after intervention, mainly collecting structural images, resting state MRI. |
| Safety measurements | 12 weeks | The safety indicators included the occurrence of adverse events and serious adverse events. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHaifeng Jiang, PhD
Shanghai Mental Health Center
Outcome results
None listed