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

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation (tDCS)
* Other: Mindfulness
* Other: Sham - Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS + Mindfulness<br> | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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.<br>Other: Mindfulness<br>* Participants will follow an audio track for guided mindfulness during the stimulation.<br>|
| Sham Comparator: Sham tDCS + Mindfulness<br> | Other: Mindfulness<br>* Participants will follow an audio track for guided mindfulness during the stimulation.<br>Other: Sham - Transcranial Direct Current Stimulation (tDCS)<br>* The tDCS device is programmed to mimic active tDCS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarette, smoking, cancer, anxiety, stress, tobacco, mindfulness