Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder

Amphetamine Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736317
• Other study ID #: MZhao-009
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Amphetamine Use Disorders
• Disease

Intervention

Device:
• sham TBS
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
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
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
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.

Locations

Country	Name	City	State
China	Shanghai Compulsory Rehabilitation Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Craving assessed by Visual Analog Scale	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.	12 months.
Secondary	Number of participants who relapse	Follow up with patients after discharge, evaluate number of participants who relapse	12 months
Secondary	Depression status assessed by Patient Health Questionnaire-9(PHQ-9)	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.	12 months
Secondary	Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)	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.	12 months
Secondary	Cognitive function assessed by CogState Battery (CSB)	evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version	12 months
Secondary	Response inhibition function	assessed by Go nogo task under the electroencephalogram recording	12 months
Secondary	Cue reactivity	assessed by Cue reactivity task under the electroencephalogram recording	12 months