Nicotine Withdrawal Symptoms and Smoking Relapse
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01511614|
Recruitment Status : Recruiting
First Posted : January 18, 2012
Last Update Posted : June 28, 2018
- 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.
- To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36 hours.
- Individuals between 18 and 55 years of age who smoke at least 10 cigarettes per day. Participants must be able to stop smoking for 36 hours on two occasions.
- This study will involve three visits to the National Institute on Drug Abuse.
- Participants will be screened with a medical history and physical exam. Blood and urine samples will be collected, as well as breath samples to test for recent alcohol use. Participants will also fill out questionnaires and learn about the tests at the next two visits.
- Before each imaging visit, participants will stop smoking for 36 hours. Before one visit, participants will wear a nicotine skin patch. Before the other visit, participants will wear a placebo (dummy) patch with no nicotine. Participants will not be told which type of patch they are wearing. Participants will measure the level of carbon monoxide in their breath during both of these nonsmoking periods. They will also complete questionnaires about mood and cigarette cravings.
- Participants will have two study visits with imaging studies to measure brain activity. Each imaging visit will last about 9 to 10 hours. The visit will involve two separate 1.5- to 2-hour scan sessions (a morning scan and an afternoon scan). These scan sessions will involve tests of concentration, memory, and reaction time. Other tests and questionnaires will also be completed outside of the scanner before and after the sessions.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||577 participants|
|Official Title:||Identifying Neurobiological Mechanisms That Underlie Acute Nicotine Withdrawal and Drive Early Relapse in Smokers|
|Study Start Date :||February 1, 2012|
- Change in BOLD signal and FC related to task parameters, Behavioral performance, and Self-reported craving, withdrawal symptoms and mood/affect. [ Time Frame: Each Scan Visit ]
- Smoking Abstinence as Determined by Self-Reported Tobacco Use, Urine Cotinine, and Breath CO. [ Time Frame: At Study Visits ]
- MRS for glutamate concentration, Plasma ACTH and cortisol, Resting state CBF, ERP and EEG measures, craving and physiological responses to physical drug cues, self-report characterization measures, & structural MRI and DTI data. [ Time Frame: At Study Visits ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511614
|Contact: Elliot Stein, Ph.D.||(443) email@example.com|
|United States, Maryland|
|National Institute on Drug Abuse||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: For more information contact Mathew's Media Group Recruiting 800-535-8254 firstname.lastname@example.org|
|Principal Investigator:||Elliot Stein, Ph.D.||National Institute on Drug Abuse (NIDA)|