AAT + tDCS to Reduce Cue-induced Craving and Smoking Behavior
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Cynthia Conklin, PhD
- Phone Number: 412-586-9840
- Email: conklinca@upmc.edu
Study Locations
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-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 26 & 55
- High treatment interest (planning to quit within the next 6 months)
- Ability to provide written informed consent
- Smoke equal or greater than 7 cigarettes per day
- Expired breath carbon monoxide (CO) equal or greater than 8 ppm at screening
- Ability to attend 10 sessions over a 3-week period, and complete 2 follow-up phone assessments
Exclusion Criteria:
- Epilepsy or Current Seizure Disorder
- Alcohol or Substance Dependence past 3 months (caffeine allowed, nicotine is part of inclusion criteria, alcohol > 14 drinks per week (M) or > 7 drinks per week (F))
- Implanted cardiac or brain medical devices
- History of epilepsy or current seizure disorder
- History of brain surgery or skull fracture
- History of a head trauma (losing consciousness >10 min and/or problems with speech or movement because of head injury)
- Latex allergy
- Scalp irritation
- History of diabetes that caused loss of consciousness (>10 min) or weakness in your arms or legs
- History of electroconvulsive therapy (ECT) in the last 5 years (Y / N) History of ECT within the last 5 years
- Current use of dextromethorphan
- Diagnosed with or undergone treatment for alcohol or substance dependence past 3 months
- Uncorrected vision deficit
- Colorblindness
- Use of tobacco products other than commercially available cigarettes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: AAT + tDCS
Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex
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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.
Other Names:
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.
Other Names:
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Sham Comparator: AAT + sham tDCS
Approach Avoidance Task with Sham Transcranial Direct Current Stimulation.
|
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.
Other Names:
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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Active Comparator: AC + tDCS
Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex
|
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.
Other Names:
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 Comparator: AC + sham tDCS
Active Control Task with sham Transcranial Direct Current Stimulation
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Change From Baseline in 4-item Questionnaire on Smoking Urges Craving Score During Cue Reactivity to Personal Cues
Time Frame: Baseline to approximately 1 week
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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.
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Baseline to approximately 1 week
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Mean Change From Baseline in Number Cigarettes Smoked Daily
Time Frame: Baseline to approximately 1 week
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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.
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Baseline to approximately 1 week
|
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Mean Change From Baseline in Number Cigarettes Smoked Daily
Time Frame: Baseline to approximately 2 weeks
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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.
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Baseline to approximately 2 weeks
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Mean Change From Baseline in Number Cigarettes Smoked Daily
Time Frame: Baseline to approximately 6-weeks
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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.
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Baseline to approximately 6-weeks
|
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Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire
Time Frame: Baseline to approximately 1-week
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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.
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Baseline to approximately 1-week
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Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire
Time Frame: Baseline to approximately 2-weeks
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Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 week post-treatment (follow-up)
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Baseline to approximately 2-weeks
|
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Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire
Time Frame: Baseline to approximately 6-weeks
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Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 month post-treatment (follow-up)
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Baseline to approximately 6-weeks
|
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Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire
Time Frame: Baseline to approximately 1-week
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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.
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Baseline to approximately 1-week
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Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire
Time Frame: Baseline to approximately 2-weeks
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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
|
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Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire
Time Frame: Baseline to approximately 6-weeks
|
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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sex as a moderator of cue-induced craving
Time Frame: Baseline to approximately 1 week
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The correlation between sex (male / female) and QSU-rating difference score (craving rating to smoking cues minus craving to neutral cues) from pre- to post training.
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Baseline to approximately 1 week
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Sex as a moderator of cigarettes smoked per day
Time Frame: Baseline to approximately 1 week
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The correlation between sex (male / female) and change in number of cigarettes smoked per day from pre- to post training.
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Baseline to approximately 1 week
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Sex as a moderator of cigarettes smoked per day
Time Frame: Baseline to approximately 2 weeks
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The correlation between sex (male / female) and change in number of cigarettes smoked per day from pre-training to 1 week follow-up.
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Baseline to approximately 2 weeks
|
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Sex as a moderator of cigarettes smoked per day
Time Frame: Baseline to approximately 6 weeks
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The correlation between sex (male / female) and change in number of cigarettes smoked per day from pre-training to 1 month follow-up.
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Baseline to approximately 6 weeks
|
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Age as a moderator of cue-induced craving
Time Frame: Baseline to approximately 1 week
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The correlation between QSU-rating difference score (craving rating to smoking cues minus craving to neutral cues) from pre- to post training.
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Baseline to approximately 1 week
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Age as a moderator of of cigarettes smoked per day
Time Frame: Baseline to approximately 1 week
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The correlation between change in number of cigarettes smoked per day from pre- to post-training.
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Baseline to approximately 1 week
|
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Age as a moderator of of cigarettes smoked per day
Time Frame: Baseline to approximately 2 weeks
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The correlation between change in number of cigarettes smoked per day from pre-training to 1 week follow-up.
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Baseline to approximately 2 weeks
|
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Age as a moderator of of cigarettes smoked per day
Time Frame: Baseline to approximately 6 weeks
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The correlation between change in number of cigarettes smoked per day from pre-training to 1 month follow-up.
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Baseline to approximately 6 weeks
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Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cue-induced craving.
Time Frame: Baseline to approximately 1 week
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The correlation between Fagerstrom Test of Nicotine Dependence (FTND)and QSU-rating difference score (craving rating to smoking cues minus craving to neutral cues) from pre- to post training.
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Baseline to approximately 1 week
|
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Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
Time Frame: Baseline to approximately 1 week
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The correlation between Fagerstrom Test of Nicotine Dependence (FTND) as a predictor of change in number of cigarettes smoked per day from pre- to post-training.
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Baseline to approximately 1 week
|
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Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
Time Frame: Baseline to approximately 2 weeks
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The correlation between Fagerstrom Test of Nicotine Dependence (FTND) as a predictor of change in number of cigarettes smoked per day from pre-training to 1-week follow-up..
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Baseline to approximately 2 weeks
|
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Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
Time Frame: Baseline to approximately 6 weeks
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The correlation between Fagerstrom Test of Nicotine Dependence (FTND) as a predictor of change in number of cigarettes smoked per day from pre-training to 1-month follow-up.
|
Baseline to approximately 6 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Cynthia Conklin, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- STUDY21020160
- 1R21DA053395-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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