UMIN-CTR Clinical Trial

Public title

Neural mechanism of impulse control on addiction by tDCS and a cognitive neuroscience approach

Acronym

A treatment option to zolpidem and nicotine dependence by tDCS

Scientific Title

Neural mechanism of impulse control on addiction by tDCS and a cognitive neuroscience approach

Scientific Title:Acronym

A treatment option to zolpidem and nicotine dependence by tDCS

Region

Asia(except Japan)

Condition

A treatment option for substance dependence

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

study aimed to evaluate potential therapeutic effects of prefrontal tDCS for the treatment of substance dependence. tDCS is a safe, powerful and non-invasive way to modulate brain activity as mentioned previously. tDCS would be applied for 10 sessions (1 session/day, 5 consecutive days/ week x 2 weeks). The study is scheduled for two years: first year would be focusing on zolpidem dependence and second year on nicotine dependece.

Basic objectives2

Others

Basic objectives -Others

It is still not clear that neural mechanism of impulse control on addiction by tDCS and neurocognitive effect by tDCS.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

BZD dependence self report questionnaire for craving of Zolpidem; Fagerstrom Test for Nicotine Dependence (FTND) for Nicotine dependence; Visual analogue scale (VAS);Depression and somatic symptoms scale (DSSS);

Key secondary outcomes

Nerocognitive testings will be also performed three times, baseline, Day 5 and 2 weeks post-treatment Go/no-go back; CANTAB

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Anodal stimulation of the left DLPFC:
The anode place at the left DLPFC and cathode placed at the right DLPFC, stimulated by tDCS. A constant current of 2mA intensity, provided by battery, was applied for 20 minutes. Stimulation with 2 mA for a single session per day. Total 10 sessions for 10 days.

Interventions/Control_2

Anodal stimulation of the right DLPFC:
The anode place at the right DLPFC and cathode placed at the left DLPFC, stimulated by tDCS. A constant current of 2mA intensity, provided by battery, was applied for 20 minutes. Stimulation with 2 mA for a single session per day. Total 10 sessions for 10 days.

Interventions/Control_3

Sham stimulation of DLPFC: electrodes placed at the bilateral DLPFC as active groups, which anode at right DLPFC in half of participants and anode at left DLPFC in another half of participants but turned off after 30 seconds of stimulation. A constant current of 2mA intensity, provided by battery, but turned off after 30 seconds of stimulation.Total 10 sessions for 10 days

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

21

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Meet the Structured Clinical Interview for DSM-IV(SCID)criteria for Zolpidem/Nicotine dependence, and the duration over one year
(2) Evaluate the comorbidity by MINI interview

Key exclusion criteria

the ones who suffer from the severe medical (i.e.: arrhythmia) or brain-injury disease (i.e.: histories ofneurostimulator implantation stroke, epilepsy, brain tumor, brain infection, brain hemorrhage, brain pressure elevation); pregnant woman; neuro-device implantation; Pacemaker; Surgical intervention of brain.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Cheng-Ta Li

Organization

Taipei Veterans General Hospital, Taiwan

Division name

Psychiatry

Zip code

Address

No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan

TEL

+81-188628757027

Email

on5083@msn.com

Name of contact person

1st name
Middle name
Last name	Cheng-Ta Li

Organization

Taipei Veterans General Hospital, Taiwan

Division name

Psychiatry

Zip code

Address

No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan

TEL

+81-188628757027

Homepage URL

Email

on5083@msn.com

Institute

Taipei Veterans General Hospital, Taiwan

Institute

Department

Personal name

Organization

Taipei Veterans General Hospital, Taiwan

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Taiwan, ROC

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

01

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2014

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

01

Month

08

Day

Last modified on

2015

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018760