Novel Intervention for Amphetamine-type Stimulants Addiction

November 30, 2019 updated by: Shanghai Mental Health Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201900
        • Shanghai Gaojing Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: control group
sham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
Radiation: sham repetitive transcranial magnetic stimulation (rTMS)
Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day
ACTIVE_COMPARATOR: rTMS group
Use 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.
Radiation: repetitive transcranial magnetic stimulation (rTMS)
Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who relapse
Time Frame: 1 month
Follow up with patients after discharge, evaluate number of participants who relapse
1 month
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)
1 month
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)
1 month
Cognitive function assessed by Cogstate Battery
Time Frame: 1 month
evaluate all participants' cognition by Cogstate Battery Chinese version
1 month
Functional connectivity assessed by MRI
Time Frame: 1 month
evaluate all participants' functional connectivity in the brain by MRI
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

Yunnan Institute For Drug Abuse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 30, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mzhao-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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