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NCT05460676 | RECRUITING | Smoking Cessation

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

Wake Forest University Health Sciences

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.

Condition or disease

Smoking Cessation

Intervention/treatment

Transcranial Direct Current Stimulation (tDCS)

Mindfulness

Sham - Transcranial Direct Current Stimulation (tDCS)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 46 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study
Actual Study Start Date : 2023-08-15
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2025-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study

Location Details

NCT05460676

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157