Trial Outcomes & Findings for Nicotine Withdrawal Symptoms and Smoking Relapse (NCT NCT01511614)
NCT ID: NCT01511614
Last Updated: 2024-05-31
Results Overview
BOLD percent signal change in right Anterior Cingulate Cortex (rACC) during parametric flanker task. This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo). The 3 task conditions are congruent (i.e. flanker stimuli are identical to target) and medium and high levels of incongruent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condidtion)
Results posted on
2024-05-31
Participant Flow
Participant milestones
| Measure |
Main Study - Treatment
Healthy male and female adults who have a history of 1 or more of consistently years smoking cigarettes with a urine cotinine level corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml, and are actively seeking treatment for smoking cessation.
Participants expected to a) complete the two pre-treatment scan visits; 2) set a quit date; 3) attempt to quit for at least 24 hours; 4) have their quit status established (i.e., relapsed vs abstinent) at 1, 6 and 12 months following their quit date.
|
Main Study - Non-Treatment
Healthy male and female adults who have a history of 1 or more years of consistently smoking cigarettes with a urine cotinine level corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml, but who are not currently seeking treatment for smoking cessation. Non-treatment seeking smokers will not set a quit date or make a quit attempt, will not complete a treatment program as part of this study and will not be followed up after they complete the two pre-treatment visits.
|
Main Study - Motivational Interviewing
Current smokers who meet criteria for participation but who are not currently ready to enter treatment for smoking cessation. These subjects will receive motivational interviewing to prepare them for a tobacco cigarette quit attempt.
|
tDCS Arm - Smoker
Healthy nicotine-dependent adult participants who are current non-treatment seeking smokers
|
tDCS - Non-Smoker
Healthy non-smoking, non-drug dependent controls
|
tDCS - Behavioral Pilot
Healthy non-smoking, non-drug dependent controls
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
28
|
2
|
32
|
33
|
3
|
|
Overall Study
COMPLETED
|
3
|
19
|
2
|
19
|
30
|
3
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
0
|
13
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Withdrawal Symptoms and Smoking Relapse
Baseline characteristics by cohort
| Measure |
Main Study - Treament
n=14 Participants
Healthy male and female adults who have a history of 1 or more of consistently years smoking cigarettes with a urine cotinine level corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml, and are actively seeking treatment for smoking cessation.
Participants expected to a) complete the two pre-treatment scan visits; 2) set a quit date; 3) attempt to quit for at least 24 hours; 4) have their quit status established (i.e., relapsed vs abstinent) at 1, 6 and 12 months following their quit date.
|
Main Study - Non-Treatment
n=28 Participants
Healthy male and female adults who have a history of 1 or more years of consistently smoking cigarettes with a urine cotinine level corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml, but who are not currently seeking treatment for smoking cessation. Non-treatment seeking smokers will not set a quit date or make a quit attempt, will not complete a treatment program as part of this study and will not be followed up after they complete the two pre-treatment visits.
|
Main Study - Motivational Interviewing Arm
n=2 Participants
Current smokers who meet criteria for participation but who are not currently ready to enter treatment for smoking cessation. These subjects will receive motivational interviewing to prepare them for a tobacco cigarette quit attempt.
|
tDCS Arm - Smoker
n=32 Participants
Healthy nicotine-dependent adult participants who are current non-treatment seeking smokers
|
tDCS - Non-Smoker
n=33 Participants
Healthy non-smoking, non-drug dependent controls
|
tDCS - Behavioral Pilot
n=3 Participants
Healthy non-smoking, non-drug dependent controls
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
112 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
108 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
62 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
28 participants
n=7 Participants
|
2 participants
n=5 Participants
|
32 participants
n=4 Participants
|
33 participants
n=21 Participants
|
3 participants
n=8 Participants
|
112 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condidtion)BOLD percent signal change in right Anterior Cingulate Cortex (rACC) during parametric flanker task. This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo). The 3 task conditions are congruent (i.e. flanker stimuli are identical to target) and medium and high levels of incongruent.
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=28 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Anodal left dlPFC stimulation, task congruent
|
1.051567464 Percent BOLD change
Standard Deviation 0.613503334
|
0.867749333 Percent BOLD change
Standard Deviation 0.632271673
|
0.8973946 Percent BOLD change
Standard Deviation 0.764795369
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Anodal left dlPFC stimulation, task medium incongruent
|
1.143702607 Percent BOLD change
Standard Deviation 0.792691244
|
1.1765768 Percent BOLD change
Standard Deviation 0.707165736
|
1.0322936 Percent BOLD change
Standard Deviation 0.970342615
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Anodal left dlPFC stimulation, task high incongruent
|
1.338308679 Percent BOLD change
Standard Deviation 0.765383086
|
1.392077933 Percent BOLD change
Standard Deviation 0.818806467
|
1.154613533 Percent BOLD change
Standard Deviation 1.057797744
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Cathodal left dlPFC stimulation, task medium incongruent
|
0.960205786 Percent BOLD change
Standard Deviation 0.738140954
|
0.986851467 Percent BOLD change
Standard Deviation 0.895053512
|
1.258576333 Percent BOLD change
Standard Deviation 1.087900913
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Cathodal left dlPFC stimulation, task high incongruent
|
1.161453536 Percent BOLD change
Standard Deviation 0.74433763
|
1.243763333 Percent BOLD change
Standard Deviation 0.985162535
|
1.451806467 Percent BOLD change
Standard Deviation 1.160555321
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Sham stimulation, task congruent
|
1.025226143 Percent BOLD change
Standard Deviation 0.527038736
|
0.6320986 Percent BOLD change
Standard Deviation 0.476573713
|
0.968123333 Percent BOLD change
Standard Deviation 0.691987432
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Cathodal left dlPFC stimulation, task congruent
|
0.925731857 Percent BOLD change
Standard Deviation 0.73461226
|
0.863549133 Percent BOLD change
Standard Deviation 0.862738124
|
1.062994933 Percent BOLD change
Standard Deviation 0.992544203
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Sham stimulation, task medium incongruent
|
1.073017964 Percent BOLD change
Standard Deviation 0.700394341
|
0.800749733 Percent BOLD change
Standard Deviation 0.653128921
|
1.046178533 Percent BOLD change
Standard Deviation 0.907522718
|
|
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
Sham stimulation, task high incongruent
|
1.35570925 Percent BOLD change
Standard Deviation 0.931955153
|
1.0759744 Percent BOLD change
Standard Deviation 0.717756041
|
1.251218733 Percent BOLD change
Standard Deviation 0.647266532
|
PRIMARY outcome
Timeframe: 12 hours nicotine abstinent (plus 1-2 hours after patch)Population: Note that the treatment part of the main arm did not take place. As a consequence, all procedures performed were identical for both 'main arm - treatment' and 'main arm - non-treatment'. As these groups are thus identical, they are combined herein.
Glutamate measured in the dorsal Anterior Cingulate Cortex (dACC) measured as a ratio to Creatine and Phosphocreatine. Cigarette smokers were 12 hour (overnight) abstinent, and had either a nicotine patch or a placebo patch placed 1-2 hours before scanning.
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=30 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=30 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
dACC Glutamate
|
1.5 ratio to Cr+PCr
Standard Error .03
|
1.54 ratio to Cr+PCr
Standard Error .029
|
—
|
PRIMARY outcome
Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)Behavioral Performance on N-Back Working Memory Task. Task consisted of 0-back, 1-back and 3-back. In this task, participants respond with a button when the current stimulus is the same as the previous one (1-back), the one 3 stimuli earlier (3-back) or the letter 'D' (0-back) depending upon task condition. Table values are accuracy as a percentage (i.e total times they reponded correctly / total trials). This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo).
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=28 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Anodal left dlPFC stimulation, task Zero-Back Condition
|
91.43 Percent Correct
Standard Deviation 15.11
|
97.56 Percent Correct
Standard Deviation 5.27
|
94.67 Percent Correct
Standard Deviation 5.75
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Anodal left dlPFC stimulation, task One-Back Condition
|
89.88 Percent Correct
Standard Deviation 13.47
|
93.33 Percent Correct
Standard Deviation 10.84
|
87.11 Percent Correct
Standard Deviation 11.88
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Anodal left dlPFC stimulation, task Three-Back Condition
|
58.93 Percent Correct
Standard Deviation 16.88
|
67.11 Percent Correct
Standard Deviation 18.89
|
58.89 Percent Correct
Standard Deviation 16.79
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Cathodal left dlPFC stimulation, task One-Back Condition
|
89.40 Percent Correct
Standard Deviation 12.00
|
91.78 Percent Correct
Standard Deviation 9.83
|
80.22 Percent Correct
Standard Deviation 20.41
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Cathodal left dlPFC stimulation, task Three-Back Condition
|
59.52 Percent Correct
Standard Deviation 14.28
|
69.78 Percent Correct
Standard Deviation 18.28
|
54.00 Percent Correct
Standard Deviation 15.18
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Sham stimulation, task Zero-Back Condition
|
89.88 Percent Correct
Standard Deviation 21.27
|
94.89 Percent Correct
Standard Deviation 13.21
|
90.89 Percent Correct
Standard Deviation 10.80
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Sham stimulation, task One-Back Condition
|
88.81 Percent Correct
Standard Deviation 16.81
|
94.00 Percent Correct
Standard Deviation 7.04
|
82.22 Percent Correct
Standard Deviation 17.31
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Sham stimulation, task Three-Back Condition
|
60.36 Percent Correct
Standard Deviation 15.11
|
70.00 Percent Correct
Standard Deviation 16.86
|
57.56 Percent Correct
Standard Deviation 19.90
|
|
Behavioral Accuracy on N-Back Working Memory Task
Percent Correct - Cathodal left dlPFC stimulation, task Zero-Back Condition
|
94.40 Percent Correct
Standard Deviation 7.65
|
98.00 Percent Correct
Standard Deviation 3.74
|
85.11 Percent Correct
Standard Deviation 15.83
|
PRIMARY outcome
Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)Behavioral Performance on N-Back Working Memory Task. Task consisted of 0-back, 1-back and 3-back. In this task, participants respond with a button when the current stimulus is the same as the previous one (1-back), the one 3 stimuli earlier (3-back) or the letter 'D' (0-back) depending upon task condition. Table values are reaction time speeds. This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo).
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=28 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Anodal left dlPFC stimulation, task Zero-Back Condition
|
2.24 1/sec
Standard Deviation .35
|
2.36 1/sec
Standard Deviation .33
|
2.20 1/sec
Standard Deviation .34
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Cathodal left dlPFC stimulation, task One-Back Condition
|
2.16 1/sec
Standard Deviation .51
|
2.28 1/sec
Standard Deviation .36
|
2.07 1/sec
Standard Deviation .36
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Cathodal left dlPFC stimulation, task Three-Back Condition
|
1.85 1/sec
Standard Deviation .63
|
1.82 1/sec
Standard Deviation .41
|
1.62 1/sec
Standard Deviation .39
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Sham stimulation, task Zero-Back Condition
|
2.22 1/sec
Standard Deviation .37
|
2.25 1/sec
Standard Deviation .37
|
2.24 1/sec
Standard Deviation .30
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Anodal left dlPFC stimulation, task One-Back Condition
|
2.13 1/sec
Standard Deviation .44
|
2.22 1/sec
Standard Deviation .28
|
2.05 1/sec
Standard Deviation .41
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Anodal left dlPFC stimulation, task Three-Back Condition
|
1.91 1/sec
Standard Deviation .59
|
1.78 1/sec
Standard Deviation .44
|
1.64 1/sec
Standard Deviation .49
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Cathodal left dlPFC stimulation, task Zero-Back Condition
|
2.26 1/sec
Standard Deviation .39
|
2.35 1/sec
Standard Deviation .36
|
2.29 1/sec
Standard Deviation .28
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Sham stimulation, task One-Back Condition
|
2.11 1/sec
Standard Deviation .52
|
2.17 1/sec
Standard Deviation .42
|
2.04 1/sec
Standard Deviation .40
|
|
Behavioral Reaction Speed on N-Back Working Memory Task
Reaction speed - Sham stimulation, task Three-Back Condition
|
1.84 1/sec
Standard Deviation .55
|
1.82 1/sec
Standard Deviation .45
|
1.71 1/sec
Standard Deviation .52
|
PRIMARY outcome
Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)Behavioral Performance on Parametric Flanker Task. Task consisted of 3 levels of difficulty: congruent trials (where distractors are the same as the target; e.g. HHHHHHH), incongruent2 trials (where the 2 furthest distractors on each side were incongruent with the target; e.g. HHSSSHH) and incongruent3 trials (where all distractors are incongruent with the target; e.g. HHHSHHH). Table values are accuracy as a percentage (i.e total times they reponded correctly / total trials). This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo).
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=28 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Sham stimulation, Incongruent2 Condition
|
98.08 Percent Correct
Standard Deviation 2.44
|
97.75 Percent Correct
Standard Deviation 4.17
|
96.95 Percent Correct
Standard Deviation 3.92
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Anodal left dlPFC stimulation, Incongruent2 Condition
|
97.97 Percent Correct
Standard Deviation 3.80
|
98.50 Percent Correct
Standard Deviation 2.57
|
98.26 Percent Correct
Standard Deviation 3.11
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Cathodal left dlPFC stimulation, Incongruent2 Condition
|
97.74 Percent Correct
Standard Deviation 4.00
|
99.04 Percent Correct
Standard Deviation 1.79
|
97.26 Percent Correct
Standard Deviation 3.74
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Anodal left dlPFC stimulation, Congruent Condition
|
98.87 Percent Correct
Standard Deviation 2.28
|
98.88 Percent Correct
Standard Deviation 1.59
|
98.83 Percent Correct
Standard Deviation 1.45
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Anodal left dlPFC stimulation, Incongruent3 Condition
|
93.62 Percent Correct
Standard Deviation 7.06
|
93.81 Percent Correct
Standard Deviation 7.75
|
89.89 Percent Correct
Standard Deviation 10.31
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Cathodal left dlPFC stimulation, Congruent Condition
|
99.08 Percent Correct
Standard Deviation 1.56
|
98.88 Percent Correct
Standard Deviation 1.83
|
97.81 Percent Correct
Standard Deviation 1.86
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Cathodal left dlPFC stimulation, Incongruent3 Condition
|
94.44 Percent Correct
Standard Deviation 5.15
|
92.72 Percent Correct
Standard Deviation 7.12
|
91.58 Percent Correct
Standard Deviation 9.16
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Sham stimulation, Congruent Condition
|
98.88 Percent Correct
Standard Deviation 1.99
|
98.83 Percent Correct
Standard Deviation 3.05
|
98.57 Percent Correct
Standard Deviation 2.05
|
|
Behavioral Accuracy on the Parametric Flanker Task
Percent Correct - Sham stimulation, Incongruent3 Condition
|
94.42 Percent Correct
Standard Deviation 5.76
|
92.62 Percent Correct
Standard Deviation 6.96
|
90.83 Percent Correct
Standard Deviation 7.65
|
PRIMARY outcome
Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)Behavioral Reaction speed on Parametric Flanker Task. Task consisted of 3 levels of difficulty: congruent trials (where distractors are the same as the target; e.g. HHHHHHH), incongruent2 trials (where the 2 furthest distractors on each side were incongruent with the target; e.g. HHSSSHH) and incongruent3 trials (where all distractors are incongruent with the target; e.g. HHHSHHH). Table values are reaction time speeds. This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo).
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=28 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Anodal left dlPFC stimulation - Incongruent2 Condition
|
2.17 1/sec
Standard Deviation .24
|
2.21 1/sec
Standard Deviation .26
|
2.08 1/sec
Standard Deviation .22
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Anodal left dlPFC stimulation- Incongruent3 Condition
|
1.94 1/sec
Standard Deviation .21
|
1.95 1/sec
Standard Deviation .22
|
1.90 1/sec
Standard Deviation .14
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Cathodal left dlPFC stimulation- Incongruent2 Condition
|
2.19 1/sec
Standard Deviation .26
|
2.24 1/sec
Standard Deviation .28
|
2.13 1/sec
Standard Deviation .27
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Anodal left dlPFC stimulation- Congruent Condition
|
2.31 1/sec
Standard Deviation .26
|
2.37 1/sec
Standard Deviation .29
|
2.23 1/sec
Standard Deviation .23
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Cathodal left dlPFC stimulation- Congruent Condition
|
2.33 1/sec
Standard Deviation .27
|
2.40 1/sec
Standard Deviation .31
|
2.25 1/sec
Standard Deviation .24
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Cathodal left dlPFC stimulation- Incongruent3 Condition
|
1.97 1/sec
Standard Deviation .26
|
1.99 1/sec
Standard Deviation .21
|
1.94 1/sec
Standard Deviation .17
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Sham stimulation - Congruent Condition
|
2.37 1/sec
Standard Deviation .29
|
2.36 1/sec
Standard Deviation .30
|
2.24 1/sec
Standard Deviation .24
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Sham stimulation- Incongruent2 Condition
|
2.19 1/sec
Standard Deviation .27
|
2.18 1/sec
Standard Deviation .26
|
2.11 1/sec
Standard Deviation .26
|
|
Behavioral Reaction Speed on the Parametric Flanker Task
Reaction speed - Sham stimulation- Incongruent3 Condition
|
1.98 1/sec
Standard Deviation .26
|
1.95 1/sec
Standard Deviation .20
|
1.90 1/sec
Standard Deviation .18
|
PRIMARY outcome
Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)Behavioral Performance on the Matching Task. Task consisted of 2 conditions: match faces, where 2 faces appeared at the top of the screen and one at the bottom (target). Participants needed to press a button corresponding to the top row face that matched the target; the control condition was identical, except instead of faces the images consisted of simple shapes (e.g. ovals). Table values are accuracy as a percentage (i.e total times they reponded correctly / total trials). This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo).
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=28 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Behavioral Accuracy on the Matching Task
Percent Correct - Anodal left dlPFC stimulation, faces condition
|
98.28 Percent Correct
Standard Deviation 2.22
|
97.02 Percent Correct
Standard Deviation 3.81
|
96.08 Percent Correct
Standard Deviation 3.64
|
|
Behavioral Accuracy on the Matching Task
Percent Correct - Cathodal left dlPFC stimulation, shapes condition
|
97.84 Percent Correct
Standard Deviation 3.17
|
97.36 Percent Correct
Standard Deviation 4.19
|
97.11 Percent Correct
Standard Deviation 4.89
|
|
Behavioral Accuracy on the Matching Task
Percent Correct - Anodal left dlPFC stimulation, shapes condition
|
96.09 Percent Correct
Standard Deviation 4.14
|
98.33 Percent Correct
Standard Deviation 2.17
|
96.58 Percent Correct
Standard Deviation 4.80
|
|
Behavioral Accuracy on the Matching Task
Percent Correct - Cathodal left dlPFC stimulation, faces condition
|
97.08 Percent Correct
Standard Deviation 3.85
|
96.43 Percent Correct
Standard Deviation 5.13
|
93.84 Percent Correct
Standard Deviation 7.77
|
|
Behavioral Accuracy on the Matching Task
Percent Correct - sham stimulation, shapes condition
|
96.28 Percent Correct
Standard Deviation 4.43
|
97.86 Percent Correct
Standard Deviation 2.11
|
95.29 Percent Correct
Standard Deviation 6.54
|
|
Behavioral Accuracy on the Matching Task
Percent Correct - sham stimulation, faces condition
|
98.21 Percent Correct
Standard Deviation 3.09
|
97.92 Percent Correct
Standard Deviation 3.56
|
94.70 Percent Correct
Standard Deviation 4.34
|
PRIMARY outcome
Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)Behavioral Reaction speed on the Matching Task. Task consisted of 2 conditions: match faces, where 2 faces appeared at the top of the screen and one at the bottom (target). Participants needed to press a button corresponding to the top row face that matched the target; the control condition was identical, except instead of faces the images consisted of simple shapes (e.g. ovals).Table values are reaction time speeds. This table is during 2mA Anodal tDCS at the left Dorsolateral prefrontal cortex (dlPFC), 2mA Cathodal tDCS at left dlPFC, or sham stimulation (i.e. placebo).
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=28 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
n=15 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Behavioral Reaction Speed on the Matching Task
Reaction speed - Sham stimulation - shapes condition
|
1.02 1/sec
Standard Deviation .18
|
1.22 1/sec
Standard Deviation .27
|
1.05 1/sec
Standard Deviation .27
|
|
Behavioral Reaction Speed on the Matching Task
Reaction speed - Sham stimulation - faces condition
|
.88 1/sec
Standard Deviation .15
|
1.0 1/sec
Standard Deviation .26
|
.86 1/sec
Standard Deviation .26
|
|
Behavioral Reaction Speed on the Matching Task
Reaction speed - Anodal left dlPFC stimulation - shapes condition
|
1.06 1/sec
Standard Deviation .19
|
1.18 1/sec
Standard Deviation .26
|
1.07 1/sec
Standard Deviation .25
|
|
Behavioral Reaction Speed on the Matching Task
Reaction speed - Anodal left dlPFC stimulation - faces condition
|
.90 1/sec
Standard Deviation .12
|
1.00 1/sec
Standard Deviation .24
|
.89 1/sec
Standard Deviation .32
|
|
Behavioral Reaction Speed on the Matching Task
Reaction speed - Cathodal left dlPFC stimulation - shapes condition
|
1.04 1/sec
Standard Deviation .20
|
1.2 1/sec
Standard Deviation .25
|
1.0 1/sec
Standard Deviation .28
|
|
Behavioral Reaction Speed on the Matching Task
Reaction speed - Cathodal left dlPFC stimulation - faces condition
|
.93 1/sec
Standard Deviation .18
|
1.0 1/sec
Standard Deviation .27
|
.82 1/sec
Standard Deviation .27
|
PRIMARY outcome
Timeframe: 12 hours nicotine abstinent (plus 1-2 hours after patch)Population: Note that the treatment part of the main arm did not take place. As a consequence, all procedures performed were identical for both 'main arm - treatment' and 'main arm - non-treatment'. As these groups are thus identical, they are combined herein.
Nicotine withdrawal as measured from the total score on the Wisconsin Smoking Withdrawal Scale (WSWS). The WSWS is a 28-item questionnaire ranging from 0 (strongly disagree) to 4 (strongly agree). The total score ranges from 0 to 112, with higher scores indicating more withdrawal symptoms. Cigarette smokers were 12 hour (overnight) abstinent and had either a nicotine patch or a placebo patch placed 1-2 hours before scanning.
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=30 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=30 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Nicotine Withdrawal From WSWS
|
43.5 score on a scale
Standard Error 2.6
|
50.8 score on a scale
Standard Error 3.1
|
—
|
PRIMARY outcome
Timeframe: 12 hours nicotine abstinent (plus 1-2 hours after patch)Population: Note that the treatment part of the main arm did not take place. As a consequence, all procedures performed were identical for both 'main arm - treatment' and 'main arm - non-treatment'. As these groups are thus identical, they are combined herein.
Nicotine craving as measured from the total score on the Tobacco Craving Questionnaire-Short Form (TCQ-SF). The TCQ-SF is a 12-item questionnaire designed to measure craving for cigarettes. Each question is answered on a 7-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Total scores range from 12 to 84, with higher scores indicating more craving. Cigarette smokers were 12 hour (overnight) abstinent and had either a nicotine patch or a placebo patch placed 1-2 hours before scanning.
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=30 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=30 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Nicotine Craving From TCQ-SF
|
46.7 score on a scale
Standard Error 2.9
|
51.9 score on a scale
Standard Error 3.6
|
—
|
PRIMARY outcome
Timeframe: 12 hours nicotine abstinent (plus 1-2 hours after patch)Population: Note that the treatment part of the main arm did not take place. As a consequence, all procedures performed were identical for both 'main arm - treatment' and 'main arm - non-treatment'. As these groups are thus identical, they are combined herein.
Positive and Negative mood from the Positive and Negative Affect Schedule (PANAS). The PANAS consists of 20 words related to emotions that participants indicate to what extent they felt this way in the last week. Words are rated from 1 (very slightly or not at all) to 5 (extremely). The PANAS is broken into a Positive and Negative subscale, each consisting of 10 questions and thus ranging from 10 to 50. Higher numbers are indicative of higher levels of positive affect and higher levels of negative affect respectively. Cigarette smokers were 12 hour (overnight) abstinent, and had either a nicotine patch or a placebo patch placed 1-2 hours before scanning.
Outcome measures
| Measure |
tDCS Arm - Non-smoker
n=30 Participants
Non-smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham.
|
tDCS Arm - Sated Smoker
n=30 Participants
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a nicotine patch 2 hrs before the scan.
|
tDCS Arm - Placebo Smoker
Nicotine cigarette smokers scanned under 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R) vmPFC, reversed polarity, and sham. Participants were 12 hours abstinent, but wearing a placebo patch 2 hrs before the scan.
|
|---|---|---|---|
|
Affect From PANAS
Positive Subscale
|
34.8 score on a scale
Standard Error 1.4
|
31.2 score on a scale
Standard Error 1.3
|
—
|
|
Affect From PANAS
Negative Subscale
|
11.7 score on a scale
Standard Error 0.4
|
13.3 score on a scale
Standard Error 1.0
|
—
|
Adverse Events
Main Study - Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Main Study - Non-Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Main Study - Motivational Interviewing Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tDCS Arm - Smoker
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
tDCS Arm - Non-Smoker
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
tDCS Arm - Behavioral Pilot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Main Study - Treatment
n=14 participants at risk
Healthy male and female adults who have a history of 1 or more of consistently years smoking cigarettes with a urine cotinine level corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml, and are actively seeking treatment for smoking cessation.
Participants expected to a) complete the two pre-treatment scan visits; 2) set a quit date; 3) attempt to quit for at least 24 hours; 4) have their quit status established (i.e., relapsed vs abstinent) at 1, 6 and 12 months following their quit date.
|
Main Study - Non-Treatment
n=28 participants at risk
Healthy male and female adults who have a history of 1 or more years of consistently smoking cigarettes with a urine cotinine level corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml, but who are not currently seeking treatment for smoking cessation. Non-treatment seeking smokers will not set a quit date or make a quit attempt, will not complete a treatment program as part of this study and will not be followed up after they complete the two pre-treatment visits.
|
Main Study - Motivational Interviewing Arm
n=2 participants at risk
Current smokers who meet criteria for participation but who are not currently ready to enter treatment for smoking cessation. These subjects will receive motivational interviewing to prepare them for a tobacco cigarette quit attempt.
|
tDCS Arm - Smoker
n=32 participants at risk
Healthy nicotine-dependent adult participants who are current non-treatment seeking smokers
|
tDCS Arm - Non-Smoker
n=33 participants at risk
Healthy non-smoking, non-drug dependent controls
|
tDCS Arm - Behavioral Pilot
n=3 participants at risk
Healthy non-smoking, non-drug dependent controls
|
|---|---|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
7.1%
2/28 • Number of events 2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
6.2%
2/32 • Number of events 2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.0%
1/33 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.6%
1/28 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
6.2%
2/32 • Number of events 2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/33 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
Cardiac disorders
Elevated Blood Pressure
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.6%
1/28 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/32 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/33 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
Cardiac disorders
Shortness of Breath/Palpitations
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.6%
1/28 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/32 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/33 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
General disorders
Dizziness
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/28 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.1%
1/32 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/33 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/28 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
6.2%
2/32 • Number of events 2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/33 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
Psychiatric disorders
Brief Psychotic Reaction
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/28 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/32 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.0%
1/33 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
General disorders
Fatigue
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/28 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.1%
1/32 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/33 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
General disorders
Nausea
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/28 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
6.2%
2/32 • Number of events 2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.0%
1/33 • Number of events 1 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
|
General disorders
General Warmth
|
0.00%
0/14 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/28 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
3.1%
1/32 • Number of events 2 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/33 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
0.00%
0/3 • From baseline to Scan 2 for tDCS Smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Scan 1 to Scan 2 for tDCS non-smoker arm (including behavioral pilot). Approximately 1 week to 3 months total. From Phase 1 (pre-treatment study visits) to Phase 3 (follow-up visits) for Treatment arm. Approximately 1 - 1.5 years total. Phase 1 only for non-treatment arm. Approximately 3 - 5 weeks total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place