Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder

NCT03736317 | Completed

• 1 other identifier: MZhao-009
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amphetamine Use Disorders

Keywords

Amphetamine-type stimulants; prefrontal-striatal circuits; rTMS; individualized therapy; craving; relapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of participants who relapse

  12 months

• Depression status assessed by Patient Health Questionnaire-9(PHQ-9)

  12 months

• Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)

  12 months

• Cognitive function assessed by CogState Battery (CSB)

  12 months

• Response inhibition function

  12 months

Study Arms (4)

control group

SHAM COMPARATOR

Sham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients. Stimulation pulses are the same as the real group.

Device: sham TBS

real mPFC cTBS group

EXPERIMENTAL

The real cTBS stimulation pattern will be delivered on the medial prefrontal cortex.

Device: real mPFC cTBS

real dlPFC iTBS group

EXPERIMENTAL

The real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex.

Device: real dlPFC iTBS

real dlPFC iTBS + real mPFC cTBS group

EXPERIMENTAL

Combination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex.

Device: real dlPFC iTBS + real mPFC cTBS

Interventions

sham TBS DEVICE

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.

control group

real mPFC cTBS DEVICE

Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.

real mPFC cTBS group

real dlPFC iTBS DEVICE

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 group

real dlPFC iTBS + real mPFC cTBS DEVICE

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.

real dlPFC iTBS + real mPFC cTBS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Compulsory Rehabilitation Center

Shanghai, Shanghai Municipality, 201900, China

Location

Related Publications (1)

• Chen T, Su H, Li R, Jiang H, Li X, Wu Q, Tan H, Zhang J, Zhong N, Du J, Gu H, Zhao M. The exploration of optimized protocol for repetitive transcranial magnetic stimulation in the treatment of methamphetamine use disorder: A randomized sham-controlled study. EBioMedicine. 2020 Oct;60:103027. doi: 10.1016/j.ebiom.2020.103027. Epub 2020 Sep 25.

  PMID: 32980696 DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Min Zhao, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

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: November 6, 2018
• First Posted: November 9, 2018
• Study Start: September 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

CN (1)