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

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Device: active tDCS; Device: sham tDCS

• Registration Number: NCT03386253
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-29
• Study Start: 2018-01-01
• Primary Completion: 2018-11-21
• Study Completion: 2018-11-21
• Results First Submitted: 2021-11-30
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-26
• Last Update Submitted: 2022-05-26
• Results First Posted: 2023-03-06
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active tDCS	active tDCS	Participants receive active tDCS for five consecutive days before attempting to quit smoking
sham tDCS	sham tDCS	Participants receive sham tDCS for five consecutive days before attempting to quit smoking

Primary Outcome Measures

Name	Time	Method
Number of Participants Willing to Complete 5 Days of tDCS or Sham	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 Outcome Measures

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

Trial Locations

Locations (1)

Clinical and Translational Sciences Institute; 🇺🇸 Minneapolis, Minnesota, United States