Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving

June 20, 2016 updated by: Laval University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

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 Contact

  • Name: Marine Mondino, PhD
  • Phone Number: 6915 418-529-9141

Study Locations

  • Canada
      • Quebec, Canada
        • Recruiting
        • Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
        • Contact:
          • Marine Mondino, PhD
          • Phone Number: 6915 418-529-9141

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active noninvasive brain stimulation and cognitive training
In active condition, subject will receive stimulation during all the 30-minute stimulation period combined with cognitive training.
Behavioral: Cognitive training
Device: Noninvasive brain stimulation (active)
Neuroconn DC-STIMULATOR PLUS
Sham Comparator: Sham noninvasive brain stimulation
In sham condition, subject will receive stimulation only during the first 30 seconds of the 30-minute stimulation period combined with cognitive training.
Behavioral: Cognitive training
Device: Noninvasive brain stimulation (sham)
Neuroconn DC-STIMULATOR PLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
immediately before and immediately after the end of the noninvasive brain stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

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

March 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-336

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.

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