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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA053395-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Smokers are highly reactive to smoking-related stimuli and report that this cue reactivity (CR) is a major obstacle to quitting. To date, no pharmacologic methods attenuate CR, and attempts to diminish it with traditional cue exposure treatment (CET) have not proven effective. The proposed study will test a highly novel cue-based smoking treatment adjunct combining an Approach/Avoidance Task (AAT) with brain stimulation via tDCS applied to the dorsolateral prefrontal cortex (dlPFC) during personalized multi-cue exposure; the goal of which is to discover an effective means of reducing cue reactivity and daily smoking, and increasing intent and confidence to quit, among high treatment-interest smokers.
Exposure to smoking-related cues robustly increases self-report craving and immediate subsequent smoking. This cue-reactivity (CR) is an often-reported obstacle to quitting among smokers. Unlike methods to diminish abstinence-induced craving, which have been highly successful with the advent of nicotine replacement therapies (NRTs), pharmacotherapies have not been shown to diminish smoking-related reactivity to cues. Past behavioral methods to reduce smokers' CR, most commonly extinction training through cue-exposure treatment (CET), have also consistently failed. Review of past CET studies reveals that this failure is largely due to several methodological shortcomings including: (1) presenting only proximal cues (e.g., cigarettes, ashtrays), (2) conducting passive unreinforced exposure to these limited cues, and (3) achieving only limited new learning. The researchers extensive past cue work makes them uniquely qualified to remedy these flaws by designing and testing novel CET methodology incorporating contemporary techniques and technology to reduce CR and relieve smokers of this ubiquitous source of relapse risk. The researchers propose three methods to improve CET. First, using well-tested methods for personalizing smoking cues and presenting numerous proximal, environment, and people cues in combination, the proposed cue exposure will better capture and target the cue-rich situations most likely to trigger smokers' strongest CR. Second, rather than repeated passive unreinforced exposure to cues, smokers will engage in active re-training of approach biases toward their personal smoking stimuli using an Approach/Avoidance Task (AAT), a method shown to activate the dorsolateral prefrontal cortex (dlPFC), a brain region associated with both cognitive control over craving and deactivation of drug reward systems. Third, to enhance new learning, smokers will undergo non-invasive transcranial direct current brain stimulation (i.e., tDCS) of the dlPFC. Although the researchers propose each method, AAT and tDCS, should independently reduce smokers' CR to their most salient cues, providing AAT with simultaneous tDCS (AAT+tDCS) should synergistically attenuate CR by better increasing cortical excitability in the dlPFC. To assess this, a 2 x 2 active and sham-controlled test of AAT and tDCS during personalized multi-cue exposures will be used to examine pre-post training changes across several measures of smoking-related cue reactivity (cue-induced craving, cue-provoked smoking topography, and attentional bias measures of Evoked Response Potentials (ERPs) and reaction time), as well as changes in daily smoking and confidence and intent to quit pre-post training and at 1 week and 1-month follow up. The goal of this work is to develop an efficacious treatment adjunct that better prepares smokers to confront cues when they try to remain quit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAT + tDCS | Experimental | Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex |
|
| AAT + sham tDCS | Sham Comparator | Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. |
|
| AC + tDCS | Active Comparator | Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex |
|
| AC + sham tDCS | Sham Comparator | Active Control Task with sham Transcranial Direct Current Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Approach/Avoidance Task | Behavioral | The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in 4-item Questionnaire on Smoking Urges Craving Score During Cue Reactivity to Personal Cues | Difference between cue-induced craving rating from pre-treatment (Baseline) to post-treatment (re-test) on the questionnaire on smoking urges 4-items scored 0-100. Lower values indicate more reduction in cue-induced craving. | Baseline to approximately 1 week |
| Mean Change From Baseline in Number Cigarettes Smoked Daily | Difference in mean number of cigarette smoker per day from pre-treatment (Baseline) to post-treatment (re-test). Lower number indicates greater reduction in cigarettes smoked. | Baseline to approximately 1 week |
| Mean Change From Baseline in Number Cigarettes Smoked Daily | Difference in mean number of cigarettes smoked per day from pre-treatment (Baseline) to 1 week post treatment (follow-up). Lower number indicates greater reduction in cigarettes smoked. | Baseline to approximately 2 weeks |
| Mean Change From Baseline in Number Cigarettes Smoked Daily | Difference in mean number of cigarette smoker per day from pre-treatment (Baseline) to 1 month post treatment (follow-up). Lower number indicates greater reduction in cigarettes smoked. | Baseline to approximately 6-weeks |
| Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire | Difference between Confidence to Quit score from pre-treatment (Baseline) to post-treatment (re-test) scored 0-100. More positive score reflects an increase in confidence to quit smoking. | Baseline to approximately 1-week |
| Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Conklin, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
Following publication, no end date
Any purpose
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Of the 79 participants who attended an inital in-person session for further screening, 23 chose not to participate in the study and 15 were deemed ineligble to continue. Forty-one participants signed informed consent and were randomized. However, 3 participants were excluded from the study after randomization leaving 38 participants contributing data and completing the study.
From 04/29/2022 - 5/21/2024, 179 participants were screened via telephone call. 79 passed inital phone screening and attended an in-person session in the research laboratory in a medical hospital setting where a full inclusion criteria assessment was conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | AAT + tDCS | Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. |
| FG001 | AAT + Sham tDCS | Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. |
| FG002 | AC + tDCS | Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. |
| FG003 | AC + Sham tDCS | Active Control Task with sham Transcranial Direct Current Stimulation AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AAT + tDCS | Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in 4-item Questionnaire on Smoking Urges Craving Score During Cue Reactivity to Personal Cues | Difference between cue-induced craving rating from pre-treatment (Baseline) to post-treatment (re-test) on the questionnaire on smoking urges 4-items scored 0-100. Lower values indicate more reduction in cue-induced craving. | 3 participants (2 from AAT + tDCS and 1 from AAT + sham tDCS) were excluded from analyses due to data collection error in which their ratings were not recorded. | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 1 week |
|
Tracking of adverse occurred over 2 years, 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AAT + tDCS | Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Conklin | University of Pittsburgh | 4125869840 | conkca@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2025 | Jan 17, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2024 | Jul 3, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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The transcranial tDCS is delivered without the participant or investigator knowing if they are receiving tDCS or not.
|
|
| Transcranial Direct Current Stimulation | Device | Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. |
|
|
| AC | Behavioral | During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. |
|
| Sham tDCS | Device | Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. |
|
Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 week post-treatment (follow-up) |
| Baseline to approximately 2-weeks |
| Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire | Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 month post-treatment (follow-up) | Baseline to approximately 6-weeks |
| Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire | Difference between Intent to Quit score from pre-treatment (Baseline) to post-treatment (re-test). Scale is rated 1-10 from 1= "I have no thoughts about or interest in quitting smoking" to 10= "I have quit and will never go back" A positive change score indicates an increased intention to quit. | Baseline to approximately 1-week |
| Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire | Difference between Intent to Quit score from pre-treatment (Baseline) to 1 week post-treatment (follow-up). Scale is rated 1-10 from 1= "I have no thoughts about or interest in quitting smoking" to 10= "I have quit and will never go back" A positive change score indicates an increased intention to quit. | Baseline to approximately 2-weeks |
| Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire | Difference between Intent to Quit score from pre-treatment (Baseline) to 1 month post-treatment (follow-up). Scale is rated 1-10 from 1= "I have no thoughts about or interest in quitting smoking" to 10= "I have quit and will never go back" A positive change score indicates an increased intention to quit. | Baseline to approximately 6-weeks |
| BG001 | AAT + Sham tDCS | Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. |
| BG002 | AC + tDCS | Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. |
| BG003 | AC + Sham tDCS | Active Control Task with sham Transcranial Direct Current Stimulation AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | AAT + Sham tDCS | Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. |
| OG002 | AC + tDCS | Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. |
| OG003 | AC + Sham tDCS | Active Control Task with sham Transcranial Direct Current Stimulation AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. |
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| Primary | Mean Change From Baseline in Number Cigarettes Smoked Daily | Difference in mean number of cigarette smoker per day from pre-treatment (Baseline) to post-treatment (re-test). Lower number indicates greater reduction in cigarettes smoked. | Posted | Mean | Standard Deviation | cigarettes per day | Baseline to approximately 1 week |
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| Primary | Mean Change From Baseline in Number Cigarettes Smoked Daily | Difference in mean number of cigarettes smoked per day from pre-treatment (Baseline) to 1 week post treatment (follow-up). Lower number indicates greater reduction in cigarettes smoked. | Posted | Mean | Standard Deviation | cigarettes per day | Baseline to approximately 2 weeks |
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| Primary | Mean Change From Baseline in Number Cigarettes Smoked Daily | Difference in mean number of cigarette smoker per day from pre-treatment (Baseline) to 1 month post treatment (follow-up). Lower number indicates greater reduction in cigarettes smoked. | 3 participants (1 from AAT + tDCS, 1 from AA + sham tDCS, and 1 from AC + tDCS) were lost to follow-up. | Posted | Mean | Standard Deviation | cigarettes per day | Baseline to approximately 6-weeks |
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| Primary | Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire | Difference between Confidence to Quit score from pre-treatment (Baseline) to post-treatment (re-test) scored 0-100. More positive score reflects an increase in confidence to quit smoking. | Data is missing from 2 participants (1 from AAT + tDCS and 1 from AC + sham tDCS) | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 1-week |
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| Primary | Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire | Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 week post-treatment (follow-up) | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 2-weeks |
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| Primary | Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire | Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 month post-treatment (follow-up) | 3 participants were lost to follow up (1 each in groups AAT + tDCS, AAT + sham tDCS, and AC+tDCS) | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 6-weeks |
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| Primary | Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire | Difference between Intent to Quit score from pre-treatment (Baseline) to post-treatment (re-test). Scale is rated 1-10 from 1= "I have no thoughts about or interest in quitting smoking" to 10= "I have quit and will never go back" A positive change score indicates an increased intention to quit. | 2 participants are not included in the analyses due to missing data (1 from AAT + tDCS, 1 from AC + sham tDCS) | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 1-week |
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| Primary | Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire | Difference between Intent to Quit score from pre-treatment (Baseline) to 1 week post-treatment (follow-up). Scale is rated 1-10 from 1= "I have no thoughts about or interest in quitting smoking" to 10= "I have quit and will never go back" A positive change score indicates an increased intention to quit. | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 2-weeks |
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| Primary | Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire | Difference between Intent to Quit score from pre-treatment (Baseline) to 1 month post-treatment (follow-up). Scale is rated 1-10 from 1= "I have no thoughts about or interest in quitting smoking" to 10= "I have quit and will never go back" A positive change score indicates an increased intention to quit. | Data from 3 participants (1 from AAT + tDCS, 1 From AAT + sham tDCS, and 1 from AC + tDCS) were lost to follow-up | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 6-weeks |
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | AAT + Sham tDCS | Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. Approach/Avoidance Task: The Approach/avoidance task (AAT) training is done using a joystick. The AAT tasks involves having participants push away pictures of smoking stimuli that appear on the screen by pushing the joystick forward, and pulling in pictures of nonsmoking stimuli that appear on the screen by pulling the joystick towards themselves. Pushing smoking-related pictures away causes the picture to shrink in size, whereas pulling a picture closer causes the picture to increase in size. This task consists of 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | AC + tDCS | Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation active (2.0 mA) (tDCS) will be used to temporarily increase cortical excitability of the dorsolateral prefrontal cortex (dlPFC) in healthy daily smokers. Participants assigned to active tDCS conditions will receive active (2.0 mA) tDCS, with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. tDCS will be administered the first 20 minutes of each of the five 30 minute AAT training sessions. AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | AC + Sham tDCS | Active Control Task with sham Transcranial Direct Current Stimulation AC: During Active Control (AC) participants press a button on the left of right of the joystick to indicate the position the picture on a screen. Position of pictures will be balanced across the 4 blocks of 24 pictures, taking 30 minutes. Sham tDCS: Sham transcranial Direct Current Stimulation (0.1 mA) (sham tDCS) will be used as a control for active tDCS with anode electrode placement over the right dlPFC and cathode electrode placement over the left bicep. Sham tDCS will be administered during the first 20 minutes of each of the four blocks of 24 pictures, taking 30 minutes, across the 5 training sessions. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |