Effects of Non-invasive Brain Stimulation in Tobacco Use... | NCT02776319

Studies
Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder

NCT02776319

Sponsor

Laval University

Status

Unknown status

Last Update Posted

May 18, 2016Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Tobacco Use Disorder

Interventions

Non-invasive brain stimulation (active)
Non-invasive brain stimulation (sham)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Sep 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

May 16, 2016

First Submission Date that Met QC Criteria

May 17, 2016

First Posted Date

May 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2016

Last Update Posted Date

May 18, 2016Estimated

Description Module

Brief Summary

The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Non-invasive brain stimulation (active)	Device: Non-invasive brain stimulation (active)
Sham/Placebo	Placebo Comparator	Non-invasive brain stimulation (sham)	Device: Non-invasive brain stimulation (sham)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-invasive brain stimulation (active)	Device	Non-invasive brain stimulation (active)	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tobacco craving	Subjective craving scale	During experimentation

Secondary Outcomes

Measure	Description	Time Frame
Brain metabolites	Magnetic resonance imaging	During experimentation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tobacco use disorder (DSM-V)

Exclusion Criteria:

Other psychiatric disorders
Contraindication to non-invasive brain stimulation and MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antoine Hone-Blanchet, MSC	Contact	4185299141	2460	antoine.hone-blanchet.1@ulaval.ca
Shirley Fecteau, PHD	Contact	4185299141	6121	Shirley.Fecteau@fmed.ulaval.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Social	Recruiting	Québec	Quebec	G1M2S8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided