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Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors

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ClinicalTrials.gov Identifier: NCT03386253
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Device: active tDCS Device: sham tDCS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: active tDCS
Participants receive active tDCS for five consecutive days before attempting to quit smoking
Device: active tDCS
two 13 minute tDCS sessions separated by 20 minutes in between

Sham Comparator: sham tDCS
Participants receive sham tDCS for five consecutive days before attempting to quit smoking
Device: sham tDCS
sham tDCS session given for same length of time as active




Primary Outcome Measures :
  1. Feasibility of using tDCS combined with cognitive training as an intervention for smoking cessation [ Time Frame: 5 weeks ]
    As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed.


Secondary Outcome Measures :
  1. Time to smoking lapse [ Time Frame: 4 weeks ]
  2. Number of cigarettes smoked per day [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between the ages of 18 and 64
  • Smoked (on average) at least 5 cigarettes per day
  • Be motivated to quit smoking

Exclusion Criteria:

  • Unstable medical or psychiatric conditions
  • Any medical conditions with neurological sequelae
  • History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
  • Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
  • Are pregnant or planning to become pregnant during the study
  • Current use of pacemaker, intracranial electrodes or implanted defibrillator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386253


Contacts
Contact: Michael Kotlyar, PharmD 612-625-1160 kotly001@umn.edu

Locations
United States, Minnesota
Clinical and Translational Sciences Institute Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michael Kotlyar    612-625-1160    kotly001@umn.edu   
Principal Investigator: Michael Kotlyar, PharmD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03386253     History of Changes
Other Study ID Numbers: AHC Seed Grant 16.51
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders