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

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 Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Device: active tDCS; Device: sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Clinical and Translational Sciences Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Willing to Complete 5 Days of tDCS or Sham	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.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Cigarettes Smoked Per Day	Change in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period.	4 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: STUDY00000789

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No