Transcranial Magnetic Stimulation for Methadone Maintenance Therapy Combined With Methamphetamine Abuse

Not Applicable

Completed

• Conditions: Methamphetamine Abuse
• Interventions: Device: repetitive transcranial magnetic stimulation (rTMS); Device: sham repetitive transcranial magnetic stimulation (rTMS)

• Registration Number: NCT04264741
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-09
• Study First Posted: 2020-02-11
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS treatment group	repetitive transcranial magnetic stimulation (rTMS)	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.
sham rTMS treatment group	sham repetitive transcranial magnetic stimulation (rTMS)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change of Craving assessed by Visual Analog Scale	12 weeks	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.
Functional magnetic resonance imaging	4 weeks	Functional magnetic resonance imaging is collected once before and once after intervention, mainly collecting structural images, resting state, and task-based fMRI
Cognitive function assessed by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	12 weeks	Evaluate all participants' cognitive function by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Chinese version

Trial Locations

Locations (1)

Wuhan Mental Health Center; 🇨🇳 Wuhan, China