Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of Participants Willing to Complete 5 Days of tDCS or Sham
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
active tDCS
Participants receive active tDCS for five consecutive days before attempting to quit smoking
Intervention: active tDCS (Device)
sham tDCS
Participants receive sham tDCS for five consecutive days before attempting to quit smoking
Intervention: sham tDCS (Device)
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)