Clinical trial NCT05460676: Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study
Official title: Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: cigarette
smoking
cancer
anxiety
stress
tobacco
mindfulness
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-07-15
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility and Tolerability Questionnaire (FTQ) score
timeFrame: 1 month
Secondary outcomes:
measure: Kessler Psychological Distress Scale (K10) Score
timeFrame: 1 month
measure: Weekly cigarette use
timeFrame: 1 month
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Merideth A Addicott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: