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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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility and Tolerability Questionnaire (FTQ) score
Secondary study objectives
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
~2150

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,606 Previous Clinical Trials
3,329,918 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,401 Previous Clinical Trials
2,460,259 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
~0 spots leftby Jan 2025
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