Clinical trial NCT04264741: Transcranial Magnetic Stimulation for Methadone Maintenance Therapy Combined With Methamphetamine Abuse
Official title: Transcranial Magnetic Stimulation for Treating Patients Under Methadone Maintenance Therapy Combined With Methamphetamine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Abuse
Keywords: repetitive transcranial magnetic stimulation (rTMS)
methamphetamine abuse
methadone maintenance therapy
urine test
relapse
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Currently in methadone maintenance therapy
* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
* Junior high school degree or above
* Normal vision and hearing

Exclusion Criteria:

* Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
* Have cognitive-promoting drugs in the last 6 months
* Other substance abuse or dependence in recent five years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders according to DSM-5 criteria
* Physical diseases

Primary outcomes:
measure: Self-report drug use and urine test
timeFrame: 16 weeks
Secondary outcomes:
measure: Change of Craving assessed by Visual Analog Scale
timeFrame: 12 weeks
measure: Cognitive function assessed by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 12 weeks
measure: Functional magnetic resonance imaging
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Haifeng Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: