Transcranial Magnetic Stimulation for Methadone Maintenance Therapy Combined With Methamphetamine Abuse

Shanghai Mental Health Center

Status: Completed

Conditions: Methamphetamine Abuse

Treatments: Device: repetitive transcranial magnetic stimulation (rTMS); Device: sham repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04264741

HFJiang-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

rTMS treatment group

Experimental group

Description:

For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 4 weeks.

Treatment:

Device: repetitive transcranial magnetic stimulation (rTMS)

sham rTMS treatment group

Sham Comparator group

Description:

For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday. Treatment will lasted for 4 weeks.

Treatment:

Device: sham repetitive transcranial magnetic stimulation (rTMS)