Back to resultsCombining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving
Primary Purpose
Tobacco Use Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive training
Noninvasive brain stimulation (active)
Noninvasive brain stimulation (sham)
Sponsored by
About this trial
This is an interventional basic science trial for Tobacco Use Disorder
Eligibility Criteria
Inclusion Criteria:
- 20-60 years old
- Smoking > 15 cigarettes per day
- Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria
Exclusion Criteria:
- Contraindications to noninvasive brain stimulation
- Psychiatric or neurologic condition
Sites / Locations
- Centre Interdisciplinaire de Recherche en Réadaptation et IntégrationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active noninvasive brain stimulation and cognitive training
Sham noninvasive brain stimulation
Arm Description
In active condition, subject will receive stimulation during all the 30-minute stimulation period combined with cognitive training.
In sham condition, subject will receive stimulation only during the first 30 seconds of the 30-minute stimulation period combined with cognitive training.
Outcomes
Primary Outcome Measures
Changes in tobacco craving assessed by the Questionnaire of Smoking Urge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02810574
Brief Title
Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active noninvasive brain stimulation and cognitive training
Arm Type
Active Comparator
Arm Description
In active condition, subject will receive stimulation during all the 30-minute stimulation period combined with cognitive training.
Arm Title
Sham noninvasive brain stimulation
Arm Type
Sham Comparator
Arm Description
In sham condition, subject will receive stimulation only during the first 30 seconds of the 30-minute stimulation period combined with cognitive training.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Type
Device
Intervention Name(s)
Noninvasive brain stimulation (active)
Intervention Description
Neuroconn DC-STIMULATOR PLUS
Intervention Type
Device
Intervention Name(s)
Noninvasive brain stimulation (sham)
Intervention Description
Neuroconn DC-STIMULATOR PLUS
Primary Outcome Measure Information:
Title
Changes in tobacco craving assessed by the Questionnaire of Smoking Urge
Time Frame
immediately before and immediately after the end of the noninvasive brain stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20-60 years old
Smoking > 15 cigarettes per day
Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria
Exclusion Criteria:
Contraindications to noninvasive brain stimulation
Psychiatric or neurologic condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marine Mondino, PhD
Phone
418-529-9141
Ext
6915
Facility Information:
Facility Name
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
City
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Mondino, PhD
Phone
418-529-9141
Ext
6915
12. IPD Sharing Statement
Learn more about this trial
Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving
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