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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-11-21

Brief Summary

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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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Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active tDCS

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

Group Type EXPERIMENTAL

active tDCS

Intervention Type DEVICE

two 13 minute tDCS sessions separated by 20 minutes in between

sham tDCS

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

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

sham tDCS session given for same length of time as active

Interventions

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active tDCS

two 13 minute tDCS sessions separated by 20 minutes in between

Intervention Type DEVICE

sham tDCS

sham tDCS session given for same length of time as active

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes