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Clinical Trials/NCT03386253
NCT03386253
Completed
Not Applicable

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

University of Minnesota1 site in 1 country16 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Use Disorder
Sponsor
University of Minnesota
Enrollment
16
Locations
1
Primary Endpoint
Number of Participants Willing to Complete 5 Days of tDCS or Sham
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
November 21, 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Number of Participants Willing to Complete 5 Days of tDCS or Sham

Time Frame: 5 days

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 Outcomes

  • Change in Number of Cigarettes Smoked Per Day(4 weeks)

Study Sites (1)

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