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active tDCS for Nicotine Addiction

N/A
Waitlist Available
Led By Amy Janes, Ph.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
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 each scan visit (2 days)
Awards & highlights

Study Summary

This trial is studying what happens in the brain when smokers try to quit, in order to better understand how to help people quit smoking. Eligible participants must be 18-65 years old, smoke at least 10 cigarettes per day, and be able to abstain from smoking for 36 hours on two occasions. The trial has three phases: in the first phase, participants will wear a nicotine patch or placebo and have MRI scans; in the second phase, participants will take the medication Chantix and have weekly counseling sessions; in the third phase, participants will have MRI scans and answer questions about their smoking behavior.

Eligible Conditions
  • Nicotine Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each scan visit (2 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and each scan visit (2 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavioral tasks
MRI BOLD signal and FC

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: active tDCSActive Control1 Intervention
(1) anodal left-dlPFC + cathodal right-vmPFC stimulation, with anode over the left dlPFC and cathode over the right-vmPFC; (2) cathodal left-dlPFC + anodal right-vmPFC stimulation, in which polarity is reversed between the two electrodes
Group II: sham tDCSPlacebo Group1 Intervention
To simulate the experience of tDCS stimulation, current is ramped on and turned off at the beginning and end of the tDCS session. An additional sham option is to have the current ramp up and down only at the beginning of the sham session, and not at the end. This second sham is supported in the literature as an effective blinding technique, which subjects cannot distinguish from active stimulation (Gandiga et al 2006, Brunoni et al 2012) . One of these sham options will be used for data that will be analyzed together, to be determined based on equipment capabilities and preliminary analysis of blinding efficacy in our cross over design. We will assess the efficacy of sham condition by providing participants and the investigator with a questionnaire on the MRI/tDCS session, wherein they will report whether they thought the tDCS session was active or sham. The MRI operator (or other non protocol personnel) will control active/sham conditions.

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Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,470 Previous Clinical Trials
2,619,619 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction
Amy Janes, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
4 Previous Clinical Trials
1,242 Total Patients Enrolled
Elliot Stein, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
24 Previous Clinical Trials
3,273 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nicotine Withdrawal Symptoms and Smoking Relapse
2013. "Nicotine Withdrawal Symptoms and Smoking Relapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01511614.
~9 spots leftby Apr 2025
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