AAT + tDCS to Reduce Cue-induced Craving and Smoking Behavior
- Conditions
- Smoking BehaviorsSmoking, Cigarette
- Interventions
- Behavioral: Approach/Avoidance TaskDevice: Sham tDCSBehavioral: ACDevice: Transcranial Direct Current Stimulation
- Registration Number
- NCT05426460
- Lead Sponsor
- Cynthia Conklin
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description AAT + sham tDCS Sham tDCS Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. AC + sham tDCS Sham tDCS Active Control Task with sham Transcranial Direct Current Stimulation AAT + sham tDCS Approach/Avoidance Task Approach Avoidance Task with Sham Transcranial Direct Current Stimulation. AAT + tDCS Approach/Avoidance Task Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex AC + tDCS AC Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex AAT + tDCS Transcranial Direct Current Stimulation Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex AC + tDCS Transcranial Direct Current Stimulation Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex AC + sham tDCS AC Active Control Task with sham Transcranial Direct Current Stimulation
- Primary Outcome Measures
Name Time Method Mean Change from baseline in rating score for 5-item Intent to Quit Questionnaire Baseline to approximately 6-weeks Difference between Intent to Quit rating from pre-treatment (Baseline) to 1 month post-treatment (follow-up)
Mean Change from baseline in rating score for Confidence to Quit Questionnaire Baseline to approximately 6-weeks Difference between Confidence to Quit score from pre-treatment (Baseline) to 1 month post-treatment (follow-up)
Mean Change from baseline in 4-item Questionnaire on Smoking Urges craving score during cue reactivity to personal cues Baseline to approximately 1 week Difference between cue-induced craving rating from pre-treatment (Baseline) to post-treatment (re-test)
Mean Change from baseline in number cigarettes smoked daily 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)
- Secondary Outcome Measures
Name Time Method Sex as a moderator of cigarettes smoked per day 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.
Sex as a moderator of cue-induced craving 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.
Age as a moderator of cue-induced craving 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.
Age as a moderator of of cigarettes smoked per day 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 measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cue-induced craving. 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 measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day 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.
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States