Nicotine Withdrawal Symptoms and Smoking Relapse

Nicotine Withdrawal Symptoms and Smoking Relapse

NCT ID: NCT01511614 Phase: NA Status: COMPLETED Enrollment: 112 Completion: 2020-03-30

Conditions

Nicotine Dependence

Interventions

Transcranial Direct Current Stimulation, sham, Nicotine patch, Placebo patch, Varenicline Pill, Placebo pill, Motivational Interviewing

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 staf

Primary Outcome

BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation

Source

ClinicalTrials.gov