- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02776319
Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder
May 17, 2016 updated by: Shirley Fecteau, Laval University
The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Quebec City, Quebec, Canada, G1M2S8
- Recruiting
- Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Social
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Tobacco use disorder (DSM-V)
Exclusion Criteria:
- Other psychiatric disorders
- Contraindication to non-invasive brain stimulation and MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active
Non-invasive brain stimulation (active)
|
Non-invasive brain stimulation (active)
|
|
Placebo Comparator: Sham/Placebo
Non-invasive brain stimulation (sham)
|
Non-invasive brain stimulation (sham)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tobacco craving
Time Frame: During experimentation
|
Subjective craving scale
|
During experimentation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain metabolites
Time Frame: During experimentation
|
Magnetic resonance imaging
|
During experimentation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
May 16, 2016
First Submitted That Met QC Criteria
May 17, 2016
First Posted (Estimate)
May 18, 2016
Study Record Updates
Last Update Posted (Estimate)
May 18, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-465
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.