NCT04139148

Brief Summary

Transcranial direct current stimulation (tDCS) combined with computerized cognitive addiction therapy(CCAT) for methamphetamine(MA) dependent patients in voluntary drug rehabilitation center. Electronic medical systems were applied for drug related knowledge education, self-evaluation and outpatient follow-up reminder after intervention in order to reduce relapse behaviors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
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
unknown

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

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 18, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

April 12, 2019

Last Update Submit

November 14, 2019

Conditions

Methamphetamine-dependenceTranscranial Direct Current StimulationComputerized Cognitive AddictionTherapyElectronic Health Records

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline cue-induced craving at 2 weeks

    Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine".

    2 weeks

  • Change from Baseline cue-induced craving at 4 weeks

    Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine".

    4 weeks

Secondary Outcomes (4)

  • Attention bias towards methamphetamine

    2 weeks，4 weeks

  • cognitive function

    2 weeks，4 weeks

  • response inhibition function

    2 weeks，4 weeks

  • reward-related function

    2 weeks，4 weeks

Study Arms (3)

True tDCS Combined With CCAT

ACTIVE COMPARATOR

Ture transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including drug knowledge every week, self-evaluation every two weeks and outpatient follow-up reminder every four weeks.

Device: Ture Transcranial Direct Current Stimulation (tDCS)

Sham tDCS Combined With CCAT

SHAM COMPARATOR

Sham transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including only outpatient follow-up reminder every four weeks.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Control group

NO INTERVENTION

During the treatment, the participants in control group only received treatment such as education of psychology, health and judicature, physical training as well as vocational training as usual in the compulsory rehabilitation center.

Interventions

Ture Transcranial Direct Current Stimulation (tDCS)DEVICE

Ture 1-2 mA current of tDCS intervention in patients' binary brain DLPFC areas(20 mm).

True tDCS Combined With CCAT
Sham Transcranial Direct Current Stimulation (tDCS)DEVICE

Sham tDCS intervention in patients' binary brain DLPFC areas(20 mm).

Sham tDCS Combined With CCAT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Methamphetamine dependent patients with normal eyesight and hearing.

You may not qualify if:

  • any diagnosis of DSM-IV axis I diseases.
  • any physical diseases which might influence cognitive function such as epilepsy, cerebrovascular disease or brain injury.
  • negative behaviors or harm to others.
  • cognitive enhance drug use history in last 6 months.
  • other drug dependence(except nicotine).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

Study Officials

  • Na Zhong, doctor

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Zhong, Doctor, doctor

CONTACT

008613671644472winco917@hotmail.com

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

April 12, 2019

First Posted

October 25, 2019

Study Start

February 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

November 18, 2019

Record last verified: 2019-10

Locations

CN(1)