Novel Intervention for Amphetamine-type Stimulants Addiction
The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction
1 other identifier
interventional
60
1 country
1
Brief Summary
The repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedDecember 3, 2019
November 1, 2019
3 years
March 7, 2016
November 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Number of participants who relapse
1 month
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
1 month
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
1 month
Cognitive function assessed by Cogstate Battery
1 month
Functional connectivity assessed by MRI
1 month
Study Arms (2)
control group
SHAM COMPARATORsham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
rTMS group
ACTIVE COMPARATORUse randomized, prospective pseudo stimulus controlled clinical trial design, evaluation of repetitive transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
Interventions
Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day
Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day
Eligibility Criteria
You may qualify if:
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Dextromanual
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Mental Health Centerlead
- Yunnan Institute For Drug Abusecollaborator
Study Sites (1)
Shanghai Gaojing Rehabilitation Center
Shanghai, Shanghai Municipality, 201900, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao Min, PhD
Shanghai Mental Health Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2016
First Posted
March 21, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
December 3, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share