AAT + tDCS to Reduce Cue-induced Craving and Smoking Behavior

Not Applicable

Completed

Conditions: Smoking Behaviors
Smoking, Cigarette

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

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 & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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) on the questionnaire on smoking urges 4-items scored 0-100. Lower values indicate more reduction in cue-induced craving.
Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire	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.
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). Lower number indicates greater reduction in cigarettes smoked.
Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire	Baseline to approximately 6-weeks	Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 month post-treatment (follow-up)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States