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

Not Applicable

Recruiting

• Conditions: Smoking Cessation
• Interventions: Other: Mindfulness; Device: Transcranial Direct Current Stimulation (tDCS); Other: Sham - Transcranial Direct Current Stimulation (tDCS)

• Registration Number: NCT05460676
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-15
• Study Start: 2023-08-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• 21-75 years old
• smoke ≥10 cigarettes per day
• mild to moderate distress (K10 scores 10-35)
• access to a reliable internet connection
• all prescription medications stable for ≥ 1 month prior to enrollment and throughout the trial, and approved by the Study Physician

Exclusion Criteria

• Current suicidal ideation
• Current use of smoking cessation medication (e.g., varenicline)
• Current use of inhaled products (other than cigarettes) which may influence exhaled carbon monoxide measures (e.g. smoking cannabis, vaping)
• History of seizure disorder, recent (<5 years) seizure history, cerebrovascular accident, neurodegenerative disease, or traumatic brain injury
• Currently receiving chemotherapy or radiation
• Presence of metal objects in the head/neck
• Any skin disorder or skin sensitive area near stimulation locations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS + Mindfulness	Mindfulness	-
Sham tDCS + Mindfulness	Sham - Transcranial Direct Current Stimulation (tDCS)	-
Active tDCS + Mindfulness	Mindfulness	-
Active tDCS + Mindfulness	Transcranial Direct Current Stimulation (tDCS)	-

Primary Outcome Measures

Name	Time	Method
Feasibility and Tolerability Questionnaire (FTQ) score	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Weekly cigarette use	1 month	The timeline follow back questionnaire (TLFB) is a self report questionnaire which asks the participant to state the number of cigarettes they have smoked each day. The total number of cigarettes smoked each week will be compiled for each participant. weekly totals will be compared between the 2 arms of the study.
Kessler Psychological Distress Scale (K10) Score	1 month	K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States