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N/A Completed N=41 Randomized Double-blind Treatment

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

Smoking Behaviors · Smoking, Cigarette
Source: ClinicalTrials.gov NCT05426460 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Mean Change From Baseline in 4-item Questionnaire on Smoking Urges Craving Score During Cue Reactivity to Personal Cues — -36.5; -36.3; -36.6; -22.2 score on a scale — p=.438

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change From Baseline in 4-item Questionnaire on Smoking Urges Craving Score During Cue Reactivity to Personal Cues
-36.5; -36.3; -36.6; -22.2 .438
PRIMARY
Mean Change From Baseline in Number Cigarettes Smoked Daily
-3.8; -5.5; -4.3; -4.6 .657
PRIMARY
Mean Change From Baseline in Rating Score for 5-item Confidence to Quit Questionnaire
2.8; 13.3; 12.2; 22.8 .732
PRIMARY
Mean Change From Baseline in Rating Score for Intent to Quit Questionnaire
1.4; 1.3; 0.6; 1.3 .353

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05426460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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