Tobacco Use Disorder
Conditions
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.
Interventions
DEVICEactive tDCS
two 13 minute tDCS sessions separated by 20 minutes in between
DEVICEsham tDCS
sham tDCS session given for same length of time as active
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS Participants receive active tDCS for five consecutive days before attempting to quit smoking
active tDCS: two 13 minute tDCS sessions separated by 20 minutes in between | 8 |
| Sham tDCS Participants receive sham tDCS for five consecutive days before attempting to quit smoking
sham tDCS: sham tDCS session given for same length of time as active | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Active tDCS | Total | Sham tDCS |
|---|---|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 10.3 | 45.9 years STANDARD_DEVIATION 11.6 | 47.0 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 2 Participants |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 6 / 8 | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
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.
Time frame: 5 days
Population: Number randomized
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active tDCS | Number of Participants Willing to Complete 5 Days of tDCS or Sham | 7 Participants |
| Sham tDCS | Number of Participants Willing to Complete 5 Days of tDCS or Sham | 8 Participants |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Number of Cigarettes Smoked Per Day | -4.03 cigarettes per day | Standard Error 1.02 |
| Sham tDCS | Change in Number of Cigarettes Smoked Per Day | -4.47 cigarettes per day | Standard Error 1.09 |
p-value: 0.77ANOVA