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

Wake Forest University (WFU)

Status

Enrolling

Conditions

Smoking Cessation

Treatments

Other: Sham - Transcranial Direct Current Stimulation (tDCS)

Device: Transcranial Direct Current Stimulation (tDCS)

Other: Mindfulness

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05460676

40010563 (Other Identifier)

IRB00076035

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

21-75 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)

Exclusion criteria

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