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NCT Number: NCT04264741

Transcranial Magnetic Stimulation for Methadone Maintenance Therapy Combined With Methamphetamine Abuse

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.

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Key information

Conditions

Methamphetamine Abuse Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Mental Health Center

Wuhan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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.

SHAM repetitive transcranial magnetic stimulation (rTMS)

Device

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.

Primary outcomes

  1. Self-report drug use and urine test

    Time frame: 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 outcomes

  1. Cognitive function assessed by RBANS

    Time frame: 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.

  2. Magnetic resonance imaging

    Time frame: 4 weeks

    Magnetic resonance imaging is collected once before and once after intervention, mainly collecting structural images, resting state MRI.

  3. Safety measurements

    Time frame: 12 weeks

    The safety indicators included the occurrence of adverse events and serious adverse events.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Transcranial Magnetic Stimulation for Treating Patients Under Methadone Maintenance Therapy Combined With Methamphetamine Abuse

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 11, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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