NCT03827785

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA) addiction in previous studies, while the evidence-based protocols still required. The aim of this research is to evaluating the effectiveness and safety of rTMS treatment in improving the days of abstinence maintenance. In addition, treatment effect on cognitive impairment, psychological craving and depression are also evaluated during the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

January 30, 2019

Last Update Submit

September 13, 2021

Conditions

Methamphetamine-dependence

Keywords

repetitive transcranial magnetic stimulation (rTMS)randomized clinical trialstreatmentcravingcognitive function

Outcome Measures

Primary Outcomes (1)

  • Negative rate urine test

    After treatment, patients will be asked to participate urine test for 12 times once a week. Loss of visit or rejection for urine test will be treated as urine test positive. Negative rate of urine drug test = actual number of negative urine tests / 12.

    12 weeks

Secondary Outcomes (3)

  • Change of Craving assessed by Visual Analog Scale

    12 weeks

  • Cognitive function assessed by CogState Battery (CSB)

    12 weeks

  • Depression status assessed by Hamilton depression scale (HAMD-17)

    12 weeks

Study Arms (2)

rTMS treatment group

EXPERIMENTAL

Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days.

Device: rTMS treatment group

sham rTMS treatment group

SHAM COMPARATOR

Stimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days.

Device: sham rTMS treatment group

Interventions

rTMS treatment groupDEVICE

For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.

rTMS treatment group
sham rTMS treatment groupDEVICE

For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.

sham rTMS treatment group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • Junior high 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Rehabilitation Center

Shanghai, 200010, China

Location

Study Officials

  • Haifeng Jiang

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

February 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 12, 2020

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

CN(1)