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Smoking BehaviorsNCT05426460

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

A study testing Approach/Avoidance Task, Transcranial Direct Current Stimulation and AC in people with Smoking Behaviors and Smoking, Cigarette, run by Cynthia Conklin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 26 to 55 years
Conditions the study is for
Smoking Behaviors, Smoking, Cigarette
What is being tested?
Approach/Avoidance Task, Transcranial Direct Current Stimulation and AC
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteUnited States
Study dates
29 Apr 2022to 14 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 26 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Being tested
Approach/Avoidance Task, Transcranial Direct Current Stimulation, AC, Sham tDCS
Keywords
Transcranial Direct Current Stimulation (tDCS), Approach Avoidance Task (AAT), Smoking
Medical subject headings
Smoking, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Approach/Avoidance TaskBehavioural

    Also called AAT

    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.

  • Transcranial Direct Current StimulationDevice

    Also called tDCS

    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.

  • ACBehavioural

    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 tDCSDevice

    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.

Study groups in NCT05426460
Study groupRoleWhat they receive
AAT + tDCSExperimentalApproach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex
Receives: Behavioral: Approach/Avoidance Task; Device: Transcranial Direct Current Stimulation
AAT + sham tDCSSham comparatorApproach Avoidance Task with Sham Transcranial Direct Current Stimulation.
Receives: Behavioral: Approach/Avoidance Task; Device: Sham tDCS
AC + tDCSActive comparatorActive Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex
Receives: Device: Transcranial Direct Current Stimulation; Behavioral: AC
AC + sham tDCSSham comparatorActive Control Task with sham Transcranial Direct Current Stimulation
Receives: Behavioral: AC; Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to approximately 1 week

  2. 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.

    Measured: Baseline to approximately 1 week

  3. 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.

    Measured: Baseline to approximately 2 weeks

  4. 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.

    Measured: Baseline to approximately 6-weeks

  5. 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.

    Measured: Baseline to approximately 1-week

  6. 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)

    Measured: Baseline to approximately 2-weeks

  7. 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)

    Measured: Baseline to approximately 6-weeks

  8. 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.

    Measured: Baseline to approximately 1-week

  9. 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.

    Measured: Baseline to approximately 2-weeks

  10. 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.

    Measured: Baseline to approximately 6-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2022
  2. Study start29 Apr 2022
  3. Primary completion15 May 2024
  4. Study completion14 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426460
Sponsor's protocol ID
STUDY21020160
Other IDs
1R21DA053395-01
Status last verified
Apr 2025
First submitted
26 May 2022
Last updated
10 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Approach/Avoidance Task, Transcranial Direct Current Stimulation and AC in people with Smoking Behaviors and Smoking, Cigarette, run by Cynthia Conklin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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