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

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active tDCS
sham tDCS
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical and Translational Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active tDCS

sham tDCS

Arm Description

Participants receive active tDCS for five consecutive days before attempting to quit smoking

Participants receive sham tDCS for five consecutive days before attempting to quit smoking

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 22, 2017
Last Updated
May 26, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03386253
Brief Title
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Official Title
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Experimental
Arm Description
Participants receive active tDCS for five consecutive days before attempting to quit smoking
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Participants receive sham tDCS for five consecutive days before attempting to quit smoking
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
two 13 minute tDCS sessions separated by 20 minutes in between
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
sham tDCS session given for same length of time as active
Primary Outcome Measure Information:
Title
Number of Participants Willing to Complete 5 Days of tDCS or Sham
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Change in Number of Cigarettes Smoked Per Day
Description
Change in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical and Translational Sciences Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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