Trial Outcomes & Findings for Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors (NCT NCT03386253)
NCT ID: NCT03386253
Last Updated: 2023-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
5 days
Results posted on
2023-03-06
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
Completed tDCS / Sham Sessions
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Baseline characteristics by cohort
| Measure |
Active tDCS
n=8 Participants
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
|
Sham tDCS
n=8 Participants
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
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Number randomized
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.
Outcome measures
| Measure |
Active tDCS
n=8 Participants
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
|
Sham tDCS
n=8 Participants
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
|
|---|---|---|
|
Number of Participants Willing to Complete 5 Days of tDCS or Sham
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4 weeksChange in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period.
Outcome measures
| Measure |
Active tDCS
n=7 Participants
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
|
Sham tDCS
n=7 Participants
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
|
|---|---|---|
|
Change in Number of Cigarettes Smoked Per Day
|
-4.03 cigarettes per day
Standard Error 1.02
|
-4.47 cigarettes per day
Standard Error 1.09
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS
n=8 participants at risk
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
|
Sham tDCS
n=8 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
25.0%
2/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
Skin and subcutaneous tissue disorders
Tingling
|
50.0%
4/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
Skin and subcutaneous tissue disorders
Itching
|
25.0%
2/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
25.0%
2/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
General disorders
Sleepiness
|
37.5%
3/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
Nervous system disorders
Poor Concentration
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
37.5%
3/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
Psychiatric disorders
Mood Change
|
0.00%
0/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
0.00%
0/8 • 5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place