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

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386253
• Other study ID #: STUDY00000789
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 21, 2018

Study information

• Verified date: May 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Device:
• active tDCS
two 13 minute tDCS sessions separated by 20 minutes in between
• sham tDCS
sham tDCS session given for same length of time as active

Locations

Country	Name	City	State
United States	Clinical and Translational Sciences Institute	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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