Clinical trial · Interventional
Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study
Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study
NCT05460676CI-TRIAL-00112915completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindfulness | Other | — | UNRESOLVED |
| Sham - Transcranial Direct Current Stimulation (tDCS) | Other | — | UNRESOLVED |
| Transcranial Direct Current Stimulation (tDCS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active tDCS + Mindfulness
- interventionNames
- Device: Transcranial Direct Current Stimulation (tDCS)
- Other: Mindfulness
- type
- SHAM_COMPARATOR
- label
- Sham tDCS + Mindfulness
- interventionNames
- Other: Mindfulness
- Other: Sham - Transcranial Direct Current Stimulation (tDCS)
Primary outcomes (1)
- measure
- Feasibility and Tolerability Questionnaire (FTQ) score
- timeFrame
- 1 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.