CompletedNot Applicable

Nicotine Withdrawal Symptoms and Smoking Relapse

United States112 participantsStarted 2013-05-20

Plain-language summary

Background: \- Smoking is thought to cause changes in the brain that lead to addiction and craving. Smokers who try to quit experience nicotine withdrawal symptoms that include irritability, anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop smoking. Many people say that they continue smoking to help relieve these symptoms, often within the first week after trying to quit. Researchers want to study what is happening in the brain to cause these symptoms, which may help identify new ways to successfully quit smoking. Objectives: \- To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36 hours. Eligibility: \- Individuals between 18 and 65 years of age who smoke at least 10 cigarettes per day. Participants must be able to stop smoking for 36 hours on two occasions. Design: Phase 1 * This study will involve three visits to the National Institute on Drug Abuse. * NOT be able to smoke for 36 hours before the two imaging visits. * Wear a nicotine skin patch or a placebo (fake) patch during your 36 hour smoking abstinence period and study visits. * Have your blood drawn to test for levels of stress-related hormones. * Complete multiple MRI scanning sessions that last about 1.5 to 2 hours each. * Undergo EEG (brain waves) recording. * Answer questionnaires about how you think and feel. * Complete various tasks and procedures inside and outside of the MRI scanner. Phase 2 * This study will involve thirteen visits to the National Institute on Drug Abuse. * Set a quit date and develop a treatment plan with a study therapist. * Take Chantix (varenicline) every day for a period of 12 weeks. * Meet for weekly and biweekly counseling sessions with a therapist. * Answer questionnaires about how you think and feel. Phase 3 * This study will involve three visits to the National Institute on Drug Abuse. * Complete an MRI scanning session that will last about 20min each visit * Meet with a study staff member on each visit who will ask you questions about your smoking behavior and how you think and feel.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: All Subjects must: * Be between the ages of 18-65. * Be right-handed. Assessment tool(s): Edinburgh Handedness Inventory. * Be in good health. Justification: Many illnesses may alter fMRI signals as well as cognitive processes and neural functioning. Assessment tool(s): Participants will provide a brief health history during phone screening, and undergo a medical history and physical examination with a qualified IRP clinician. * Be free of current moderate to severe DSM-V Substance Use Disorder on any drug, except nicotine in smokers. Those with past moderate to severe use disorder on substances may be included, provided they are in sustained remission (and not on maintenance therapy for opioid use disorder) and are not intoxicated on the day of the imaging session. Justification: Moderate to severe use disorder on other substances may result in unique CNS deficits that could confound results and introduce excessive variance, while mild substance use disorder and substance use disorder in remission are common in community samples of smokers. Assessment tool(s): Computerized SCID or comparable assessment and DSM-5 substance use disorder assessment. * Be able to abstain from alcohol and other recreational drugs for 24 hours before each imaging session, and able to moderate caffeine intake 12 hours before each imaging session. Justification: Recent substance use, including alcohol, and caffeine modulate neural functioning in a way that would complicate da…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condidtion)

dACC Glutamate

Timeframe: 12 hours nicotine abstinent (plus 1-2 hours after patch)

Behavioral Accuracy on N-Back Working Memory Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)

Behavioral Reaction Speed on N-Back Working Memory Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)

Behavioral Accuracy on the Parametric Flanker Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)

Behavioral Reaction Speed on the Parametric Flanker Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)

Trial details

NCT IDNCT01511614

SponsorNational Institute on Drug Abuse (NIDA)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-03-30

Results submitted2023-08-09

View on ClinicalTrials.gov More Nicotine Dependence trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condidtion)

dACC Glutamate

Timeframe: 12 hours nicotine abstinent (plus 1-2 hours after patch)

Behavioral Accuracy on N-Back Working Memory Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)

Behavioral Reaction Speed on N-Back Working Memory Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)

Behavioral Accuracy on the Parametric Flanker Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)

Behavioral Reaction Speed on the Parametric Flanker Task

Timeframe: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)