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NCT01867411 · ClinicalTrials.gov registry record
Multimodal Neuroimaging Genetic Biomarkers of Nicotine AddictionSeverity
A clinical trial, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- 159
- Enrollment target
NCT01867411: Completed study, sponsored by National Institute on Drug Abuse (NIDA).
NCT01867411 is a clinical trial that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 159 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01867411 has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- 159 participants
- Enrollment target
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
Primary Outcome
1\) Change in BOLD signal and functional connectivity related to task parameters, between drug conditions (i.e. on and off nicotine) and between groups: will provide important insight into the neurobiological mechanisms underlying acute and chronic nicotine withdrawal, in particular those related to anhedonia, negative affect, cognitive control and impulsive decision making.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2013-11-06 |
What the finished NCT01867411 record still lists
NCT01867411 is an observational study that tracks outcomes without assigning an intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01867411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01867411 about?
NCT01867411 is a clinical study titled "Multimodal Neuroimaging Genetic Biomarkers of Nicotine AddictionSeverity". 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...
What is the current status of trial NCT01867411?
This trial is currently completed. The enrollment target is 159 participants. The study started on 2013-11-06.
Who is sponsoring clinical trial NCT01867411?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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