Multimodal Neuroimaging Genetic Biomarkers of Nicotine AddictionSeverity

Nicotine Dependence Clinical Trial

Official title: Multimodal Neuroimaging Genetic Biomarkers of Nicotine Addiction Severity

Status Recruiting

Clinical Trial Summary

Background:

• Smoking is a difficult habit to quit, and some people find it more difficult to quit than others do. Nicotine is the substance in cigarettes that makes smoking so addictive. Nicotine changes some patterns of brain activity, and smokers have differences in brain activity when compared to non-smokers. Some genes make it more likely that a person will become addicted to smoking. Researchers want to study how nicotine interacts with genes and brain activity. This may help develop better treatments to help people quit smoking.

Objectives:

• To develop a test of nicotine dependence, using brain activity and genetic analysis, which may be useful in predicting success in smoking cessation and in the development of new smoking cessation treatment targets.

Eligibility:

• Main group: Current smokers between 18 and 55 years of age who are seeking treatment to quit.

• Comparison group: Current smokers between 18 and 55 years of age who are not seeking to quit.

• Comparison group: Healthy former smokers between 18 and 55 years of age.

• Comparison group: Healthy nonsmoking volunteers between 18 and 55 years of age.

Design:

• Participants will be screened with a physical exam and medical history. Blood samples will be collected.

• The three comparison groups will have one magnetic resonance imaging (MRI) scan session. They will have tests of thinking, concentration, and memory both inside the scanner, and while sitting in front of a computer.

• Current smokers who are trying to quit must be willing to undergo a course of nicotine treatment that includes weekly counseling (for 12 weeks) and e-cigarettes. Participants will attempt smoking abstinence and will have a total of 6 MRI scanning sessions. They will do thinking, concentration, and memory tasks inside and outside of the scanner.

• For smokers, the first scanning session will take place before they attempt to quit. This will be a baseline scan. The second scanning session will take place 48 hours after having their last real cigarette. After this scan, they will use electronic cigarettes to help quit their habit.

• After using e-cigarettes for two weeks, smokers will have a third scan session.. They will then gradually taper their use of the electronic cigarettes over the course of three weeks, at which point they will be nicotine abstinent.

• After about 5 weeks of abstinence, they will have the fourth scan. The fifth scan will be approximately 6 months after start of the study, and the final scan will take place at about 1 year from the study start.

• Smokers will continue to receive support on quitting smoking until the study ends at about 1 year.

Clinical Trial Description

Objective: To develop a neuroimaging/genetic/epigenetic biomarker of nicotine dependence severity that may be useful in predicting success in smoking cessation and in development of new smoking cessation treatment targets. Further, by evaluating those who vape nicotine, findings will determine whether biomarkers differ between those who smoke or vape, allowing for the development of cessation

strategies that relate to preferred nicotine delivery.

Study population: Four groups will be studied: target group of treatment seeking smokers/vapers; nontreatment seeking current smokers/vapers; never smokers/never vapers and former smokers. We estimate that we will need n=50/subgroup completers to have sufficient power to develop the brain/genetics biomarkers.

Design: This study consists of a 4 group between/within subject design. The experimental group will proceed in 4 phases: Baseline (scan 1), peak withdrawal (scan 2), stable on nicotine replacement (scan 3), and complete abstinence (scans 4-6). Counseling will start after the first scan session and will generally continue weekly until scan 4 (about 12 weeks). After scan 4, therapeutic support will be

provided at least monthly via phone until completion of the protocol. The non-treatment seeker comparison group will be scanned twice; at baseline (scan 1) and at peak withdrawal (scan 2). Each of the non-nicotine user comparison groups (non-nicotine users and Ex-smokers) will be scanned only at baseline (scan 1). Genetic and epigenetic markers will be obtained in all groups.

Outcome measures: Network and multivariate pattern analysis, behavior on a decision making task and task based and resting state blood oxygen level-dependent (BOLD) activation in neural circuits relevant to nicotine addiction during fMRI scanning. Secondary outcomes include BOLD response comparisons between nicotine replacement and typical nicotine use and genetic markers of nicotine addiction and relapse susceptibility. ;

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

• NCT number: NCT01867411
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: NIDA IRP Screening Team
• Phone: (800) 535-8254
• Email: researchstudies@nida.nih.gov
• Status: Recruiting
• Start date: November 6, 2013