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Multimodal Neuroimaging Genetic Biomarkers of Nicotine AddictionSeverity

NCT01867411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 159

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Nicotine Dependence

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-06
Primary Completion
2024-06-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867411 on ClinicalTrials.gov