Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study
NCT ID: NCT05460676
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2023-08-15
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Active tDCS + Mindfulness
Transcranial Direct Current Stimulation (tDCS)
tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp.
Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.
Sham tDCS + Mindfulness
Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.
Sham - Transcranial Direct Current Stimulation (tDCS)
The tDCS device is programmed to mimic active tDCS.
Interventions
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Transcranial Direct Current Stimulation (tDCS)
tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp.
Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.
Sham - Transcranial Direct Current Stimulation (tDCS)
The tDCS device is programmed to mimic active tDCS.
Eligibility Criteria
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Inclusion Criteria
* Smoke ≥5 cigarettes per day and express interest in quitting smoking in next 30 days
* Mild to moderate distress defined as K10 scores 10-35
* Self reported previous diagnosis of cancer
* Psychotropic medication stable for ≥1 month prior to enrollment and throughout the trial, at the discretion of the study physician
* Access to a reliable internet connection, able to use mobile device, and complete online questionnaires, competent in instrumental activities of daily living
* Able to read and understand informed consent and questionnaires in English (WRAT-4 score≥85)
Exclusion Criteria
* Chronic non-compliance with study procedures
* Changes in health information over the course of enrollment in the study which place the participant at higher risk for an adverse event (as determined by Study Physician or Principal Investigator; e.g. medication changes, invasive procedures)
* Temporary or permanent obstructions to making contact between the electrodes and the scalp (e.g. wig that the participant is not willing to remove)
* History of traumatic brain injury, brain metastases, seizure disorder, recent (\<5 years) seizure history, or a neurodegenerative disease or neurocognitive disorder associated with significant impairment (e.g. Parkinson's, Dementia)
* Current severe major depressive disorder, lifetime history of psychotic disorders or bipolar disorder type I, or current suicidal ideation
* Currently meets DSM-5 criteria for severe substance use disorder in the past 6 months for any psychoactive substance other than tobacco
* Current suicidal ideation (as determined by the MINI)
* Current use of prescription or over the counter smoking cessation medication, or primary use of non-combustible forms of nicotine/tobacco
* Currently receiving intravenous chemotherapy or radiation treatments
* Presence of metal objects in the head/neck
* Any skin disorder or skin sensitive area near stimulation locations
* Self-reported pregnancy
* Enrolled in group or individual therapy for smoking cessation that would be concurrent to intervention
21 Years
75 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Merideth A Addicott, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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40010563
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00076035
Identifier Type: -
Identifier Source: org_study_id