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Behavioural Intervention

AAT + tDCS for Smoking Cessation

N/A
Waitlist Available
Led By Cynthia Conklin, PhD
Research Sponsored by Cynthia Conklin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 26 & 55
Be between 18 and 65 years old
Must not have
History of a head trauma (losing consciousness >10 min and/or problems with speech or movement because of head injury)
History of brain surgery or skull fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to approximately 6 weeks
Awards & highlights

Summary

This trial will test a new treatment for smokers that includes exposure to smoking-related stimuli combined with brain stimulation in an attempt to reduce smoking and increase the intent to quit.

Who is the study for?
This trial is for smokers aged 26-55 who smoke more than 7 cigarettes daily, have a high interest in quitting within the next six months, and can commit to attending ten sessions over three weeks plus two phone follow-ups. Participants must not have epilepsy, substance dependence (except nicotine), brain devices, significant head trauma history, severe allergies like latex or uncontrolled diabetes.Check my eligibility
What is being tested?
The study tests a new treatment combining an Approach/Avoidance Task (AAT) with Transcranial Direct Current Stimulation (tDCS) targeting the brain's prefrontal cortex during exposure to smoking cues. The aim is to reduce cravings and smoking behavior while boosting confidence and intent to quit.See study design
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site on the scalp, itching or tingling sensations during stimulation, fatigue, headache or nausea. However, these are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 26 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a severe head injury that caused me to lose consciousness or have speech/movement issues.
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I have had brain surgery or a skull fracture in the past.
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I am currently taking dextromethorphan.
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I have epilepsy or a current seizure disorder.
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I have epilepsy or a current seizure disorder.
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I have scalp irritation.
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I have diabetes that has caused me to faint or feel weak in my limbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to approximately 6-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to approximately 6-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change from baseline in 4-item Questionnaire on Smoking Urges craving score during cue reactivity to personal cues
Mean Change from baseline in number cigarettes smoked daily
Mean Change from baseline in rating score for 5-item Intent to Quit Questionnaire
+1 more
Secondary outcome measures
Age as a moderator of cue-induced craving
Age as a moderator of of cigarettes smoked per day
Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: AAT + tDCSExperimental Treatment2 Interventions
Approach Avoidance Task + Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex
Group II: AC + tDCSActive Control2 Interventions
Active Control Task with Transcranial Direct Current Stimulation targeting the dorsolateral prefrontal cortex
Group III: AAT + sham tDCSPlacebo Group2 Interventions
Approach Avoidance Task with Sham Transcranial Direct Current Stimulation.
Group IV: AC + sham tDCSPlacebo Group2 Interventions
Active Control Task with sham Transcranial Direct Current Stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Cynthia ConklinLead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,503 Total Patients Enrolled
68 Trials studying Smoking
22,671 Patients Enrolled for Smoking
Cynthia Conklin, PhDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Approach/Avoidance Task (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05426460 — N/A
Smoking Research Study Groups: AAT + tDCS, AAT + sham tDCS, AC + tDCS, AC + sham tDCS
Smoking Clinical Trial 2023: Approach/Avoidance Task Highlights & Side Effects. Trial Name: NCT05426460 — N/A
Approach/Avoidance Task (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05426460 — N/A
~25 spots leftby Jul 2025
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