- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426460
AAT + tDCS to Reduce Cue-induced Craving and Smoking Behavior
January 5, 2024 updated by: Cynthia Conklin
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cynthia Conklin, PhD
- Phone Number: 412-586-9840
- Email: conklinca@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh
-
Sub-Investigator:
- Shachi Tyagi, MD
-
Contact:
- Cynthia Conklin, PhD
- Phone Number: 412-586-9840
- Email: conklinca@upmc.edu
-
Sub-Investigator:
- Brian Coffman, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years to 55 years (Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AAT + tDCS
Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex
|
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:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Difference between cue-induced craving rating from pre-treatment (Baseline) to post-treatment (re-test)
|
Baseline to approximately 1 week
|
Mean Change from baseline in number cigarettes smoked daily
Time Frame: Baseline to approximately 1 week
|
Difference in mean number of cigarette smoker per day from pre-treatment (Baseline) to post-treatment (re-test)
|
Baseline to approximately 1 week
|
Mean Change from baseline in number cigarettes smoked daily
Time Frame: Baseline to approximately 2 weeks
|
Difference in mean number of cigarette smoker per day from pre-treatment (Baseline) to 1 week post treatment (follow-up)
|
Baseline to approximately 2 weeks
|
Mean Change from baseline in number cigarettes smoked daily
Time Frame: Baseline to approximately 6-weeks
|
Difference in mean number of cigarette smoker per day from pre-treatment (Baseline) to 1 month post treatment (follow-up)
|
Baseline to approximately 6-weeks
|
Mean Change from baseline in rating score for 5-item Intent to Quit Questionnaire
Time Frame: Baseline to approximately 1-week
|
Difference between Intent to Quit score from pre-treatment (Baseline) to post treatment (re-test)
|
Baseline to approximately 1-week
|
Mean Change from baseline in rating score for 5-item Intent to Quit Questionnaire
Time Frame: Baseline to approximately 2-weeks
|
Difference between Intent 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 Intent to Quit Questionnaire
Time Frame: Baseline to approximately 6-weeks
|
Difference between Intent 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 Confidence to Quit Questionnaire
Time Frame: Baseline to approximately 1-week
|
Difference between Confidence to Quit score from pre-treatment (Baseline) to post-treatment (re-test)
|
Baseline to approximately 1-week
|
Mean Change from baseline in rating score for Confidence to Quit Questionnaire
Time Frame: Baseline to approximately 2-weeks
|
Difference between Confidence to Quit score from pre-treatment (Baseline) to 1 week post-treatment (follow-up)
|
Baseline to approximately 2-weeks
|
Mean Change from baseline in rating score for Confidence to Quit Questionnaire
Time Frame: Baseline to approximately 6-weeks
|
Difference between Confidence to Quit score from pre-treatment (Baseline) to 1 month post-treatment (follow-up)
|
Baseline to approximately 6-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sex as a moderator of cue-induced craving
Time Frame: Baseline to approximately 1 week
|
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.
|
Baseline to approximately 1 week
|
Sex as a moderator of cigarettes smoked per day
Time Frame: Baseline to approximately 1 week
|
The correlation between sex (male / female) and change in number of cigarettes smoked per day from pre- to post training.
|
Baseline to approximately 1 week
|
Sex as a moderator of cigarettes smoked per day
Time Frame: Baseline to approximately 2 weeks
|
The correlation between sex (male / female) and change in number of cigarettes smoked per day from pre-training to 1 week follow-up.
|
Baseline to approximately 2 weeks
|
Sex as a moderator of cigarettes smoked per day
Time Frame: Baseline to approximately 6 weeks
|
The correlation between sex (male / female) and change in number of cigarettes smoked per day from pre-training to 1 month follow-up.
|
Baseline to approximately 6 weeks
|
Age as a moderator of cue-induced craving
Time Frame: Baseline to approximately 1 week
|
The correlation between QSU-rating difference score (craving rating to smoking cues minus craving to neutral cues) from pre- to post training.
|
Baseline to approximately 1 week
|
Age as a moderator of of cigarettes smoked per day
Time Frame: Baseline to approximately 1 week
|
The correlation between change in number of cigarettes smoked per day from pre- to post-training.
|
Baseline to approximately 1 week
|
Age as a moderator of of cigarettes smoked per day
Time Frame: Baseline to approximately 2 weeks
|
The correlation between change in number of cigarettes smoked per day from pre-training to 1 week follow-up.
|
Baseline to approximately 2 weeks
|
Age as a moderator of of cigarettes smoked per day
Time Frame: Baseline to approximately 6 weeks
|
The correlation between change in number of cigarettes smoked per day from pre-training to 1 month follow-up.
|
Baseline to approximately 6 weeks
|
Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cue-induced craving.
Time Frame: Baseline to approximately 1 week
|
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.
|
Baseline to approximately 1 week
|
Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
Time Frame: Baseline to approximately 1 week
|
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.
|
Baseline to approximately 1 week
|
Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
Time Frame: Baseline to approximately 2 weeks
|
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..
|
Baseline to approximately 2 weeks
|
Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
Time Frame: Baseline to approximately 6 weeks
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Conklin, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2022
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
June 15, 2022
First Posted (Actual)
June 22, 2022
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 5, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
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)?
YES
IPD Plan Description
All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
IPD Sharing Time Frame
Following publication, no end date
IPD Sharing Access Criteria
Any purpose
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking, Cigarette
-
Maastricht University Medical CenterCompletedCigarette Smoking | Cigarette Smoking Toxicity | Smoking BehaviorNetherlands
-
Duke UniversityGeorgetown University; University of MichiganWithdrawnSmoking | Cigarette Smoking | E-cigarette Use
-
Assistance Publique - Hôpitaux de ParisUnknownSmoking Cessation | Smoking, Cigarette | Electronic CigaretteFrance
-
Yale UniversityNational Cancer Institute (NCI)RecruitingSmoking Cessation | Cigarette Smoking | E-Cigarette UseUnited States
-
Medical University of South CarolinaAmerican Cancer Society, Inc.RecruitingSmoking Cessation | Electronic Cigarette Use | Cigarette SmokingUnited States
-
University of St AndrewsNational Health Service, United KingdomUnknownSmoking | Cigarette Smoking | Smoking, Tobacco
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); New York University; Stanford UniversityRecruitingSmoking | Smoking, Tobacco | Smoking, CigaretteUnited States
-
BIDI VaporCompletedCigarette Smoking | E-cigarette UsePoland
-
National Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Cigarette Smoking | Tobacco, SmokingUnited States
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
Clinical Trials on Approach/Avoidance Task
-
Technische Universität DresdenCharite University, Berlin, Germany; University Hospital Carl Gustav CarusCompleted
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Substance Use Disorders | Cannabis Use | Alcohol Use, UnspecifiedUnited States
-
Bram VervlietUnknownAnorexia Nervosa | Anxiety | Eating DisordersBelgium
-
Turning PointMonash University; Deakin UniversityCompleted
-
Medical University of South CarolinaCompletedAlcohol Approach/Avoidance Task | Sham Approach/Avoidance TaskUnited States
-
Mclean HospitalRecruitingObsessive-Compulsive Disorder | Obsessive-compulsive Disorders and SymptomsUnited States
-
University GhentUniversity of Amsterdam; PZ Heilig Hart; PZ Sint-CamillusCompletedAlcohol DependenceBelgium
-
Raquel Vilar LópezMinisterio de Ciencia, Innovación y Universidades, SpainCompletedObesity | OverweightSpain
-
Universitätsklinikum Hamburg-EppendorfOdense University Hospital; Pomeranian Medical University Szczecin; European... and other collaboratorsUnknownAlcohol Use Disorder
-
University of Texas at AustinCompleted