Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study

NCT05460676 | Recruiting DMC FDA Device

• 2 other identifiers: IRB00076035R21DA055426
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the feasibility of using Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) as a tool to decreasing distress and cigarette smoking. 46 participants currently smoking cigarettes, and seeking to decrease cigarette use will be recruited.

Conditions

Smoking Cessation

Keywords

cigarette; smoking; cancer; anxiety; stress; tobacco; mindfulness

Outcome Measures

Primary Outcomes (1)

• Feasibility and Tolerability Questionnaire (FTQ) score

  The FTQ is a questionnaire is a 10 question survey which will be used to determine the ease and comfort of device use. Each question will be rated on a scale of 1 - 10, with 1 indicating the greatest difficulty or discomfort, and 10 indicating the greatest ease or tolerability. Questions for which the population average is greater than or equal to 5 will be deemed well tolerated.

  1 month

Secondary Outcomes (2)

• Kessler Psychological Distress Scale (K10) Score

  1 month

• Weekly cigarette use

  1 month

Study Arms (2)

Active tDCS + Mindfulness

EXPERIMENTAL

Device: Transcranial Direct Current Stimulation (tDCS); Other: Mindfulness

Sham tDCS + Mindfulness

SHAM COMPARATOR

Other: Mindfulness; Other: Sham - Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Active tDCS + Mindfulness

Mindfulness OTHER

Participants will follow an audio track for guided mindfulness during the stimulation.

Active tDCS + Mindfulness; Sham tDCS + Mindfulness

Sham - Transcranial Direct Current Stimulation (tDCS) OTHER

The tDCS device is programmed to mimic active tDCS.

Sham tDCS + Mindfulness

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• 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)

You may not qualify if:

• Inability to effectively use study-provided supplies
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Smoking; Neoplasms; Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation; Mindfulness

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Merideth A Addicott, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janvi Patel

CONTACT

704-355-2000; Janvi.Patel@wfusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: July 15, 2022
• Study Start: August 15, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to chanlon@wakehealth.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)