Novel Intervention for Amphetamine-type Stimulants Addiction

Amphetamine Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713815
• Other study ID #: Mzhao-004
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: November 2019
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Amphetamine Addiction
• Amphetamine-Related Disorders
• Behavior, Addictive

Intervention

Radiation:
• repetitive transcranial magnetic stimulation (rTMS)
Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day
• sham repetitive transcranial magnetic stimulation (rTMS)
Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day

Locations

Country	Name	City	State
China	Shanghai Gaojing Rehabilitation Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Yunnan Institute For Drug Abuse

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month	evaluate all participants' craving for ATS by Visual Analog Scales (VAS)	Baseline and 1 month
Secondary	Number of participants who relapse	Follow up with patients after discharge, evaluate number of participants who relapse	1 month
Secondary	Depression status assessed by Patient Health Questionnaire-9(PHQ-9)	evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9)	1 month
Secondary	Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)	evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7)	1 month
Secondary	Cognitive function assessed by Cogstate Battery	evaluate all participants' cognition by Cogstate Battery Chinese version	1 month
Secondary	Functional connectivity assessed by MRI	evaluate all participants' functional connectivity in the brain by MRI	1 month