Transcranial Magnetic Stimulation for Methadone Maintenance Therapy Combined With Methamphetamine Abuse

NCT04264741 | Completed

• 1 other identifier: HFJiang-004
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Abuse

Keywords

repetitive transcranial magnetic stimulation (rTMS); methamphetamine abuse; methadone maintenance therapy; urine test; relapse

Outcome Measures

Primary Outcomes (1)

• Self-report drug use and urine test

  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).

  16 weeks

Secondary Outcomes (3)

• Change of Craving assessed by Visual Analog Scale

  12 weeks

• Cognitive function assessed by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  12 weeks

• Functional magnetic resonance imaging

  4 weeks

Study Arms (2)

rTMS treatment group

EXPERIMENTAL

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.

Device: repetitive transcranial magnetic stimulation (rTMS)

sham rTMS treatment group

SHAM COMPARATOR

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.

Device: sham repetitive transcranial magnetic stimulation (rTMS)

Interventions

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.

rTMS treatment group

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.

sham rTMS treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Wuhan Mental Health Center

Wuhan, China

Location

MeSH Terms

Conditions

Recurrence

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Haifeng Jiang, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 11, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 2, 2026

Record last verified: 2024-03

Locations

CN (1)