NCT04993300

Brief Summary

The study aims to test whether transcranial magnetic stimulation (TMS) improves the craving, depression, anxiety and cognitive function during the abstinent period of methamphetamine users.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 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

July 21, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

July 21, 2021

Last Update Submit

March 28, 2023

Conditions

CravingDepression, AnxietyAmphetamine Addiction

Keywords

Addictionamphetaminetranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (Taiwanese version)

    Respondents will specify their level of craving from none to extreme on a 100 mm line (score: 0-10) in each questionnaires, and there are nine questionnaires related to craving.

    20 weeks

Secondary Outcomes (4)

  • The Beck depression inventory (Taiwanese version BDI)

    20 weeks

  • The Beck anxiety inventory (Taiwanese version BAI)

    20 weeks

  • Cognitive function

    20 weeks

  • Tolerance

    20 weeks

Study Arms (1)

transcranial magnetic stimulation (TMS)

EXPERIMENTAL

This arm constitute of methamphetamine users who undergone abstinent period

Device: transcranial magnetic stimulation (TMS)

Interventions

transcranial magnetic stimulation (TMS)DEVICE

The methamphetamine user will undergo a one-month TMS intervention. In Week 1, subjects will attend continuously 5 daily TMS sessions. From Week 2 to Week 4, subjects are treated once a week. Each session will have 40 repeats of 4-second train and 15-sec train interval.

transcranial magnetic stimulation (TMS)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranged 20-65.
  • Under judicially supervised outpatient-based methamphetamine abuse treatment program

You may not qualify if:

  • Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).
  • Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder
  • patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.
  • patients who have metal implants in their bodies, as well as those with metal implants.
  • people who have damaged skin in areas of the patient's body that receive stimulation.
  • patients with multiple sclerosis.
  • patients who have extensive ischemic scarring.
  • pregnant women.
  • patients with a family history of spasms/epilepsy
  • patients taking medications that may lower the seizure threshold.
  • patients with severe sleep disorders related to previous rTMS treatment.
  • patients with severe heart disease
  • patients with intracranial stress caused by uncontrollable migraines.
  • people who have been evaluated by a physician as unfit to participate in clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersAmphetamine-Related DisordersBehavior, Addictive

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSubstance-Related DisordersChemically-Induced DisordersCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Chen Cheng-Che, MD,MSc

    Physician, Department if Psychiatry, National Taiwan University Hospital - Biomedical Park Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 6, 2021

Study Start

February 17, 2022

Primary Completion

August 4, 2022

Study Completion

August 4, 2022

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

TW(1)