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Effects of Nicotine on Brain Activity as Measured by fMRI
NCT01037153 · View on ClinicalTrials.gov ↗
Study Summary
Background: \- Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research is needed to determine how different doses of nicotine and different intervals of receiving nicotine affect brain function. A greater understanding of nicotine's effect on the brain, as studied through functional magnetic resonance imaging (fMRI), may improve the effectiveness of smoking cessation therapies and treatments. Objectives: \- To determine the effects of nicotine on brain function and chemistry in experienced cigarette smokers. Eligibility: \- Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50 years of age. Design: * The study involves five separate research experiments. Most participants will be involved in only one experiment. * The experiments will evaluate brain activity and function using fMRI. Participants will be trained in a series of tests on cognitive function before beginning the experimental part of the study. * Experiment 1: Participants will have three fMRI scan sessions after receiving different dose levels of intravenous nicotine. * Experiment 2: Participants will have four fMRI scan sessions after receiving two doses of nicotine separated by 1/4, 1/2, 3, and 24 hours. * Experiment 3: Participants will have two sets of nicotine injections separated by 45 minutes, with each injection series containing five rapid injections of small amounts of nicotine (to mimic five puffs on a cigarette). * Experiment 4: Participants will have three fMRI sessions after receiving a single injection of nicotine at three different rates (over 15, 60, or 120 seconds). In addition there will be three more sessions involving a nicotine patch and a nicotine injection as well as a placebo session. * Experiment 5: Participants will
Conditions Studied
Study Locations (1)
Maryland
- National Institute on Drug Abuse, Biomedical Research Center (BRC) — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2002-08-06 |
| Est. Completion | 2011-07-25 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01037153
The ClinicalTrials.gov registry entry for NCT01037153 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 108 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Nicotine Dependence appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01037153 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01037153 about?
NCT01037153 is a clinical study titled "Effects of Nicotine on Brain Activity as Measured by fMRI". Background: \- Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research i...
What is the current status of trial NCT01037153?
This trial is currently completed. The enrollment target is 128 participants. The study started on 2002-08-06. Estimated completion is 2011-07-25.
What conditions does trial NCT01037153 study?
This clinical trial studies the following conditions: Nicotine Dependence, Drug Abuse. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01037153?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 108 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01037153 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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