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Completed

NCT Number: NCT03386253

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

Device

two 13 minute tDCS sessions separated by 20 minutes in between

Sham tDCS

Device

sham tDCS session given for same length of time as active

Primary outcomes

  1. 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

  1. Change in Number of Cigarettes Smoked Per Day

    Time frame: 4 weeks

    Change in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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