Back to resultsEffects of Non-invasive Brain Stimulation in Tobacco Use Disorder
Primary Purpose
Tobacco Use Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Non-invasive brain stimulation (active)
Non-invasive brain stimulation (sham)
Sponsored by
About this trial
This is an interventional basic science trial for Tobacco Use Disorder focused on measuring Non-invasive brain stimulation, tobacco use disorder, craving
Eligibility Criteria
Inclusion Criteria:
- Tobacco use disorder (DSM-V)
Exclusion Criteria:
- Other psychiatric disorders
- Contraindication to non-invasive brain stimulation and MRI
Sites / Locations
- Centre Interdisciplinaire de Recherche en Réadaptation et Intégration SocialRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Sham/Placebo
Arm Description
Non-invasive brain stimulation (active)
Non-invasive brain stimulation (sham)
Outcomes
Primary Outcome Measures
Tobacco craving
Subjective craving scale
Secondary Outcome Measures
Brain metabolites
Magnetic resonance imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02776319
Brief Title
Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
4. Oversight
5. Study Description
Brief Summary
The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Non-invasive brain stimulation, tobacco use disorder, craving
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Non-invasive brain stimulation (active)
Arm Title
Sham/Placebo
Arm Type
Placebo Comparator
Arm Description
Non-invasive brain stimulation (sham)
Intervention Type
Device
Intervention Name(s)
Non-invasive brain stimulation (active)
Intervention Description
Non-invasive brain stimulation (active)
Intervention Type
Device
Intervention Name(s)
Non-invasive brain stimulation (sham)
Intervention Description
Non-invasive brain stimulation (sham)
Primary Outcome Measure Information:
Title
Tobacco craving
Description
Subjective craving scale
Time Frame
During experimentation
Secondary Outcome Measure Information:
Title
Brain metabolites
Description
Magnetic resonance imaging
Time Frame
During experimentation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tobacco use disorder (DSM-V)
Exclusion Criteria:
Other psychiatric disorders
Contraindication to non-invasive brain stimulation and MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Hone-Blanchet, MSC
Phone
4185299141
Ext
2460
Email
antoine.hone-blanchet.1@ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Fecteau, PHD
Phone
4185299141
Ext
6121
Email
Shirley.Fecteau@fmed.ulaval.ca
Facility Information:
Facility Name
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Social
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1M2S8
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder
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