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Completed

NCT Number: NCT02713815

Novel Intervention for Amphetamine-type Stimulants Addiction

The repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.

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Key information

Conditions

Amphetamine Addiction Amphetamine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Gaojing Rehabilitation Center

Shanghai, Shanghai Municipality, 201900, China

About this study

The Glutamate and GABA deficits in prefrontal cortex play a vital role in ATS addiction and relapse, and proposed repetitive transcranial magnetic stimulation (rTMS) as a novel interventions. Focused on evaluating Glutamate/GABA functions in prefrontal cortex and functional connectivity with deep brain regions, neuropsychological tests, biochemical tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to investigate the neurobiological mechanism of ATS addiction and relapse. These methods will also be used to evaluate the efficacy of the novel intervention and investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related 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
  • Dextromanual

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

repetitive transcranial magnetic stimulation (rTMS)

Radiation

Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day

sham repetitive transcranial magnetic stimulation (rTMS)

Radiation

Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day

Primary outcomes

  1. Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month

    Time frame: Baseline and 1 month

    evaluate all participants' craving for ATS by Visual Analog Scales (VAS)

Secondary outcomes

  1. Number of participants who relapse

    Time frame: 1 month

    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: 1 month

    evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9)

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

    Time frame: 1 month

    evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7)

  4. Cognitive function assessed by Cogstate Battery

    Time frame: 1 month

    evaluate all participants' cognition by Cogstate Battery Chinese version

  5. Functional connectivity assessed by MRI

    Time frame: 1 month

    evaluate all participants' functional connectivity in the brain by MRI

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • Yunnan Institute For Drug Abuse

Registry information

Official study title

The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2016
Registry last updated
Dec 3, 2019

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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