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Completed

NCT Number: NCT05426460

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

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.

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Key information

Conditions

Smoking Behaviors Behavior Cigarette Smoking Smoking Smoking, Cigarette Tobacco Smoking Tobacco Use

Age range

26 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Approach/Avoidance Task

Behavioral

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: AAT

Transcranial Direct Current Stimulation

Device

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: tDCS

AC

Behavioral

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 tDCS

Device

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.

Primary outcomes

  1. 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) on the questionnaire on smoking urges 4-items scored 0-100. Lower values indicate more reduction in cue-induced craving.

  2. 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). Lower number indicates greater reduction in cigarettes smoked.

  3. Mean Change From Baseline in Number Cigarettes Smoked Daily

    Time frame: Baseline to approximately 2 weeks

    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.

  4. 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). Lower number indicates greater reduction in cigarettes smoked.

  5. Mean Change From Baseline in Rating Score for 5-item 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) scored 0-100. More positive score reflects an increase in confidence to quit smoking.

  6. Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire

    Time frame: Baseline to approximately 2-weeks

    Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 week post-treatment (follow-up)

  7. Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire

    Time frame: Baseline to approximately 6-weeks

    Difference between Confidence to Quit rating from pre-treatment (Baseline) to 1 month post-treatment (follow-up)

  8. Mean Change From Baseline in Rating Score for 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). 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.

  9. Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire

    Time frame: Baseline to approximately 2-weeks

    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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Cynthia Conklin

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2022
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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