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

NCT05426460 | Completed Results FDA Device

• 2 other identifiers: STUDY210201601R21DA053395-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Behaviors; Smoking, Cigarette

Keywords

Transcranial Direct Current Stimulation (tDCS); Approach Avoidance Task (AAT); Smoking

Outcome Measures

Primary Outcomes (10)

• Mean Change From Baseline in 4-item Questionnaire on Smoking Urges Craving Score During Cue Reactivity to Personal Cues

  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.

  Baseline to approximately 1 week

• Mean Change From Baseline in Number Cigarettes Smoked Daily

  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.

  Baseline to approximately 1 week

• Mean Change From Baseline in Number Cigarettes Smoked Daily

  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.

  Baseline to approximately 2 weeks

• Mean Change From Baseline in Number Cigarettes Smoked Daily

  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.

  Baseline to approximately 6-weeks

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

  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.

  Baseline to approximately 1-week

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

  Difference between Confidence 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 Confidence to Quit Questionnaire

  Difference between Confidence 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 Intent to Quit Questionnaire

  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.

  Baseline to approximately 1-week

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

  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.

  Baseline to approximately 2-weeks

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

  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.

  Baseline to approximately 6-weeks

Study Arms (4)

AAT + tDCS

EXPERIMENTAL

Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex

Behavioral: Approach/Avoidance Task; Device: Transcranial Direct Current Stimulation

AAT + sham tDCS

SHAM COMPARATOR

Approach Avoidance Task with Sham Transcranial Direct Current Stimulation.

Behavioral: Approach/Avoidance Task; Device: Sham tDCS

AC + tDCS

ACTIVE COMPARATOR

Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex

Device: Transcranial Direct Current Stimulation; Behavioral: AC

AC + sham tDCS

SHAM COMPARATOR

Active Control Task with sham Transcranial Direct Current Stimulation

Behavioral: AC; Device: Sham tDCS

Interventions

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.

Also known as: AAT

AAT + sham tDCS; AAT + tDCS

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.

Also known as: tDCS

AAT + tDCS; AC + 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.

AC + sham tDCS; AC + tDCS

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.

AAT + sham tDCS; AC + sham tDCS

Eligibility Criteria

• Age: 26 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Epilepsy or Current Seizure Disorder
• 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

Sponsors & Collaborators

• Cynthia Conklin: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Smoking; Cigarette Smoking

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Cynthia Conklin
• Organization: University of Pittsburgh

conkca@upmc.edu

4125869840

Study Officials

• Cynthia Conklin, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The transcranial tDCS is delivered without the participant or investigator knowing if they are receiving tDCS or not.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 22, 2022
• Study Start: April 29, 2022
• Primary Completion: May 15, 2024
• Study Completion: June 14, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication, no end date
• Access Criteria: Any purpose

Locations

US (1)