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tDCS + Mindfulness for Smoking Cessation

N/A

Recruiting

Led By Colleen A Hanlon, Ph.D.

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study Summary

This trial seeks to use electric brain stimulation to reduce distress and smoking in 46 smokers, in hopes of decreasing cigarette use. #smoking #tDCS

Who is the study for?

This trial is for individuals aged 21-75 who smoke at least 10 cigarettes daily, experience mild to moderate distress, and have stable internet access. Participants must not be using smoking cessation meds or inhaled products other than cigarettes, nor have a history of seizures, brain injuries, or metal objects in the head/neck.Check my eligibility

What is being tested?

The study tests if Transcranial Direct Current Stimulation (tDCS) can help reduce cigarette smoking and distress. It involves mindfulness practices and either real tDCS or a sham procedure as control. The participants will be randomly assigned to one of these interventions.See study design

What are the potential side effects?

Potential side effects from tDCS may include discomfort at the stimulation site on the scalp, itching, tingling sensations during treatment sessions, headache after treatment sessions, fatigue or nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility and Tolerability Questionnaire (FTQ) score

Secondary outcome measures

Kessler Psychological Distress Scale (K10) Score

Weekly cigarette use

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCS + MindfulnessExperimental Treatment2 Interventions

Group II: Sham tDCS + MindfulnessPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation (tDCS)

2016

Completed Phase 2

~2100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,684 Total Patients Enrolled

Colleen A Hanlon, Ph.D.Principal InvestigatorWake Forest University Health Sciences

1 Previous Clinical Trials

15 Total Patients Enrolled

Merideth A Addicott, Ph.D.Principal InvestigatorWake Forest University Health Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are being approved to participate in this clinical experiment?

"Affirmative. The listing on clinicaltrials.gov verifies that this medical research, which was initially created in mid-August 2023, is currently open to recruitment. A total of 46 participants need to be enrolled from a single location."

Answered by AI

Are older individuals being considered as candidates for this research project?

"To be considered for this study, applicants must fall between the ages of 21 and 75. Additionally, there are 7 studies dedicated to younger patients (under 18) and 128 for those 65 years or older."

Answered by AI

Are there any remaining spots available for participants in this trial?

"Yes, the details posted on clinicaltrials.gov confirm that this study is currently recruiting patients and has been since August 15th 2023. The most recent update was made on October 4th 2023 and 46 participants are needed from a single medical facility."

Answered by AI

Are there any limitations to who can take part in this clinical trial?

"This smoking cessation trial is open to 46 individuals aged 21-75 who meet the following conditions: consume at least 10 cigarettes per day, present mild to moderate distress (K10 scores 10-35), possess a steady internet connection, and have no changes in their prescription medications for one month prior and throughout the testing period. In addition, they must be approved by an assigned Study Physician."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05460676.

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