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Completed

NCT Number: NCT03736317

Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder

Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of methamphetamine-dependent patients.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Compulsory Rehabilitation Center

Shanghai, Shanghai Municipality, 201900, China

About this study

The limbic circuit and executive control circuit are two important frontal-striatal neural circuits associated with drug dependence. Previous studies showed increased functional activity within the limbic neural circuit (e.g. medial prefrontal cortex (mPFC) and ventral striatum) in the presence of a salient cue and decreased activity in the executive control circuit (e.g. dorsal prefrontal cortex and dorsal striatum). TMS was used to reverse the activities of these two circuits, by using continuous TBS and intermittent TBS, respectively. In this study, vmPFC cTBS was conducted to modulating the limbic circuit, while left dlPFC iTBS was conducted to modulating the executive control circuit. Combined treatment of vmPFC cTBS and left dlPFC iTBS was conducted to modulating two circuits simultaneously. Focused on evaluating the efficacy of the interventions and investigate the mechanisms, neuropsychological tests, biochemical tests, and electroencephalography will be used to investigate the neurobiological mechanism of the methamphetamine use disorder, craving, and relapse. The study will be very helpful to develop evidence-based rTMS protocols for methamphetamine-dependent patients in clinical practice and decrease harm for both the patients and their families.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
  • Primary school degree or above
  • Normal vision and hearing
  • Dextromanual
  • Less than one month before last drug use

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
  • Physical disease

Treatment and study plan

Sham TBS

Device

Stimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil.

real mPFC cTBS

Device

Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.

real dlPFC iTBS

Device

Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.

real dlPFC iTBS + real mPFC cTBS

Device

Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.

Primary outcomes

  1. Change of Craving assessed by Visual Analog Scale

    Time frame: 12 months.

    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.

Secondary outcomes

  1. Number of participants who relapse

    Time frame: 12 months

    Follow up with patients after discharge, evaluate number of participants who relapse

  2. Depression status assessed by Patient Health Questionnaire-9(PHQ-9)

    Time frame: 12 months

    evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression.

  3. Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)

    Time frame: 12 months

    evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). PHQ-9 range from 0 to 21, and higher values represent more severe level of anxiety.

  4. Cognitive function assessed by CogState Battery (CSB)

    Time frame: 12 months

    evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version

  5. Response inhibition function

    Time frame: 12 months

    assessed by Go nogo task under the electroencephalogram recording

  6. Cue reactivity

    Time frame: 12 months

    assessed by Cue reactivity task under the electroencephalogram recording

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Craving in Methamphetamine Use Disorder

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2018
Registry last updated
Sep 16, 2021

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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