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Behaviors such as tobacco use, unhealthy diet, and sedentary behavior have far-reaching health implications. These modifiable behaviors account for a substantial proportion of deaths from cancer, cardiovascular disease and diabetes, and take a significant economic toll. Yet, many unhealthy behaviors are very resistant to change, despite widespread knowledge of the risks. Although theories of behavior change have been advanced to explain the persistence of these behaviors, few consider the neurobehavioral underpinnings. These approaches also fail to address a fundamental aspect of behavior change - an individual's ability to exert sufficient self-control to overcome temptations for immediate gratification and/or to maintain attention to long-term goals. With advances in the neuroimaging field, the investigators are learning where and how self-control over decisions and behaviors is executed in the brain. This work points to the central role of neural activity in the dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy choices. Further, emerging evidence shows that activity in the prefrontal cortices and cognitive control circuits can be modulated using a noninvasive and safe intervention: direct current transcranial stimulation (tDCS). The investigators pilot study, IRB study #820231, demonstrated that a single session of 1mA tDCS increased the ability to resist smoking in a validated smoking lapse paradigm. The current study will use a between-subject design to investigate the dose/response relationship between tDCS (administered at 1mA, 2mA, or sham stimulation for three sessions) and ability to resist smoking.
This trial will use a between-subject single blind design in which participants will be randomized to one of three tDCS dosage groups (1mA, 2mA or sham) and will receive three 20 minute sessions of the same dosage over the course of 1 week before completing a 7 day quit attempt. Eligible participants will complete an Intake Visit (week -1) for final eligibility determination, and complete baseline measures (if eligible). Participants will then be randomly assigned to one of the three dosage groups (1mA, 2mA or sham) and will attend three identical tDCS resist-smoking sessions (study days 1, 3, & 5) during which they will receive 20 minutes of their assigned tDCS dosage and complete cognitive tasks and a resist smoking paradigm. During the resist smoking sessions, participants will receive a session of their assigned dosage of tDCS for 20 minutes while being exposed to in vivo smoking cues (their cigarette pack, cigarettes, an ashtray). Participants will not be informed of their dosage condition. During and after the tDCS session, participants will have the opportunity to smoke in the approved smoking lab. The investigators will measure time to first cigarette and subsequent ad libitum smoking during the resist smoking paradigm. Following Session 3 participants will receive a 20 minute coaching session from a trained smoking cessation counselor to help them prepare for a 7-day quit attempt. During the 7-day quit attempt participants will be asked to attend 4 monitoring visits (study days 6, 8, 10 & 12) to confirm smoking status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham dose | Sham Comparator | Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS. |
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| 1mA dose | Experimental | Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
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| 2 mA dose | Experimental | Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (tDCS) | Device | Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS. |
| Measure | Description | Time Frame |
|---|---|---|
| Resisting Smoking - Time to First Cigarette in the Resist Smoking Paradigm | Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is time to first cigarette in minutes. | During laboratory session on day 5, assessed for up to 2 hours |
| Resisting Smoking - Number of Cigarettes Smoked in the Resist Smoking Paradigm | Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is number of cigarettes smoked. | During laboratory session on day 5, assessed for up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urge to Smoke for Negative Affect Relief | The 10-item brief QSU (QSU-B) questionnaire will be used to assess smoking urges. The QSU-B contains 2 subscales (anticipation of reward, relief from negative affect). The QSU-B with a "Right Now" frame of reference will be administered before the smoking resist paradigm. Urge to smoke for negative affect relief (QSU-B Factor 2) has been linked to outcomes for the smoking resist paradigm. The range of possible scores is 4 to 28, with higher scores indicating greater urges. |
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Inclusion Criteria:
Exclusion Criteria:
Alcohol/Drugs:
Medication:
Current use or recent discontinuation (within the last 14 days at the time of Intake) of:
Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix);
Anti-psychotic medications;
Nicotine replacement therapy (NRT);
GABAergic medications;
Glutamatergic medications;
Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician.
Daily use of:
Opiate-containing medications for chronic pain;
Benzodiazepines.
Medical/Neuropsychiatric:
tDCS-related:
General Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Caryn Lerman, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Dose | Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS. |
| FG001 | 1mA Dose | Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
| FG002 | 2 mA Dose | Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Dose | Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Resisting Smoking - Time to First Cigarette in the Resist Smoking Paradigm | Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is time to first cigarette in minutes. | Posted | Mean | Standard Deviation | minutes | During laboratory session on day 5, assessed for up to 2 hours |
|
1 week
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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 | Sham Dose | Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Falcone, Ph.D. | University of Pennsylvania | 215-746-3782 | mfalc@pennmedicine.upenn.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 | May 10, 2017 | Feb 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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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|
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| During laboratory session on day 5, assessed for up to 2 hours |
| Number of Days Abstinent From Cigarettes During Monitored Abstinence Period | Number of days of biochemically verified abstinence during the monitoring period will be recorded. | Assessed during 7-day monitored abstinence period during study days 6 - 12 |
| Revealed exclusionary condition |
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| Adverse Event |
|
| BG001 | 1mA Dose | Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
| BG002 | 2 mA Dose | Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nicotine dependence (FTND score) | The Fagerstrom Test for Nicotine Dependence (FTND) is a validated 6-item measure assessing physical and physiological symptoms of nicotine dependence. The range of scores possible is 0-9; higher scores indicate greater levels of dependence. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 1mA Dose | Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
| OG002 | 2 mA Dose | Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). |
|
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| Primary | Resisting Smoking - Number of Cigarettes Smoked in the Resist Smoking Paradigm | Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is number of cigarettes smoked. | Posted | Mean | Standard Deviation | cigarettes | During laboratory session on day 5, assessed for up to 2 hours |
|
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|
|
| Secondary | Urge to Smoke for Negative Affect Relief | The 10-item brief QSU (QSU-B) questionnaire will be used to assess smoking urges. The QSU-B contains 2 subscales (anticipation of reward, relief from negative affect). The QSU-B with a "Right Now" frame of reference will be administered before the smoking resist paradigm. Urge to smoke for negative affect relief (QSU-B Factor 2) has been linked to outcomes for the smoking resist paradigm. The range of possible scores is 4 to 28, with higher scores indicating greater urges. | Posted | Mean | Standard Deviation | units on a scale | During laboratory session on day 5, assessed for up to 2 hours |
|
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| Secondary | Number of Days Abstinent From Cigarettes During Monitored Abstinence Period | Number of days of biochemically verified abstinence during the monitoring period will be recorded. | Posted | Mean | Standard Deviation | Days | Assessed during 7-day monitored abstinence period during study days 6 - 12 |
|
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|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 1mA Dose | Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). | 0 | 53 | 0 | 53 | 1 | 53 |
| EG002 | 2 mA Dose | Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). transcranial direct current stimulation (tDCS): Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system). | 0 | 47 | 0 | 47 | 3 | 47 |
| high blood pressure | Vascular disorders | Non-systematic Assessment |
|
| Bike accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Tingling and burning sensation | Nervous system disorders | Non-systematic Assessment |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |