Nicotine Withdrawal Symptoms and Smoking Relapse

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.

Conditions

• Nicotine Dependence

Interventions

DEVICE

Transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation (tDCS), a type of Non-invasive Brain Stimulation (NIBS), has the potential to modify neuronal circuits by application of a subthreshold conductive current through the scalp. Two potential targets for tDCS as a smoking cessation aid are the dorsolateral pre-frontal cortex (dlPFC), a node of the ECN, and the ventromedial prefrontal cortex (vmPFC), a node of the DMN. tDCS can potentially strengthen the control of the ECN through excitatory stimulation of the dlPFC, and weaken the influence of the DMN (Lerman et al 2014) by inhibitory stimulation of the vmPFC. The tDCS model we will use is the neuroConn DC-Stimulator MR (neuroCare Group GmbH, Munchen, Germany).

DEVICE

sham

Sham Comparator

DRUG

Nicotine patch

Dose-match Nicotine for non-deprived scan

DRUG

Placebo patch

Nicotine deprived

DRUG

Varenicline Pill

Treatment

DRUG

Placebo pill

Active comparator to varenicline

BEHAVIORAL

Motivational Interviewing

Motivational Interviewing for smoking cessation preparation

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  lead NIH

Principal Investigators

• Amy Janes, Ph.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-20

Primary Completion

2020-03-30

Completion

2020-03-30

Countries

• United States

Study Locations