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

Smoking Cessation Clinical Trial

Official title:

Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460676
• Other study ID #: IRB00076035
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: Hilary R Smith
• Phone: 336-716-5181
• Email: hsmith[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)
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.

Other:
• Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.
• Sham - Transcranial Direct Current Stimulation (tDCS)
The tDCS device is programmed to mimic active tDCS.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kessler Psychological Distress Scale (K10) Score	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.	1 month
Secondary	Weekly cigarette use	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.	1 month