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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jul 11, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study" is exploring a new way to help people quit smoking. Researchers want to see if a technique called Transcranial Direct Current Stimulation (tDCS) can reduce feelings of distress and help smokers cut down on their cigarette use. They are looking for 46 participants aged 21 to 75 who currently smoke at least 10 cigarettes a day and have mild to moderate feelings of distress. Participants must also have stable prescription medications and a reliable internet connection to take part in the study.

If you decide to join the trial, you can expect to receive tDCS through a device used at home, with guidance from the research team. However, there are some important criteria to keep in mind: you should not be currently taking smoking cessation medications or other inhaled products, and you must not have certain medical conditions like a history of seizures or specific skin issues near the stimulation area. This study is currently recruiting participants, and it aims to provide valuable insights into new methods for helping people quit smoking.

Gender

ALL

Eligibility criteria

• 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