Smoking CessationNCT05460676
Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study
A study testing Transcranial Direct Current Stimulation (tDCS) and Mindfulness in people with Smoking Cessation, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Mindfulness
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study
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
- Smoking Cessation
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Mindfulness, Sham - Transcranial Direct Current Stimulation (tDCS)
- Keywords
- cigarette, smoking, cancer, anxiety, stress, tobacco, mindfulness
- Medical subject headings
- Smoking Cessation, Smoking, Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
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.
MindfulnessOther
Participants will follow an audio track for guided mindfulness during the stimulation.
Sham - Transcranial Direct Current Stimulation (tDCS)Other
The tDCS device is programmed to mimic active tDCS.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Mindfulness | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation (tDCS); Other: Mindfulness |
| Sham tDCS + Mindfulness | Sham comparator | Not described Receives: Other: Mindfulness; Other: Sham - Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Aug 2023
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Merideth A Addicott, Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460676
- Sponsor's protocol ID
- IRB00076035
- Other IDs
- R21DA055426
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study
- ClinicalTrials.gov ID
- NCT05460676
- Acronym / sponsor ID
- IRB00076035
- Conditions
- Smoking Cessation
- Keywords
- cigarette, smoking, cancer, anxiety, stress, tobacco, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Mindfulness | Experimental | Device: Transcranial Direct Current Stimulation (tDCS), Other: Mindfulness |
| Sham tDCS + Mindfulness | Sham comparator | Other: Mindfulness, Other: Sham - Transcranial Direct Current Stimulation (tDCS) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active tDCS + Mindfulness |
| MindfulnessParticipants will follow an audio track for guided mindfulness during the stimulation. | Other | Active tDCS + Mindfulness, Sham tDCS + Mindfulness |
| Sham - Transcranial Direct Current Stimulation (tDCS)The tDCS device is programmed to mimic active tDCS. | Other | Sham tDCS + Mindfulness |
Primary outcome
Feasibility and Tolerability Questionnaire (FTQ) score
Time frame: 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.
2 secondary outcomes
Kessler Psychological Distress Scale (K10) Score
Time frame: 1 month
Weekly cigarette use
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merideth A Addicott, Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) and Mindfulness in people with Smoking Cessation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Tolerability Questionnaire (FTQ) score (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.