Novel Intervention for Amphetamine-type Stimulants Addiction

NCT ID: NCT02713815

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Amphetamine Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type SHAM_COMPARATOR

sham repetitive transcranial magnetic stimulation (rTMS)

Intervention Type RADIATION

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

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.

Group Type ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type RADIATION

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

Interventions

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repetitive transcranial magnetic stimulation (rTMS)

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

Intervention Type RADIATION

sham repetitive transcranial magnetic stimulation (rTMS)

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yunnan Institute For Drug Abuse

UNKNOWN

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhao Min, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Gaojing Rehabilitation Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Mzhao-004

Identifier Type: -

Identifier Source: org_study_id

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