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Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence
NCT01034384 · View on ClinicalTrials.gov ↗
Study Summary
Background: * Denicotinized cigarettes are similar to commercial cigarettes but contain and deliver virtually no nicotine. Denicotinized cigarettes are used as a control condition in smoking research, as a substitute treatment for nicotine dependence, and as a strategy to reduce incidence of nicotine addiction. However, the symptoms of nicotine withdrawal and craving for cigarettes must be minimized to ensure that smokers will continue to use denicotinized cigarettes instead of their preferred cigarettes. * Although research has shown that smokers preferred cigarettes that delivered nicotine, subjective measures of tobacco craving and withdrawal were similar after standard and denicotinized cigarettes. This suggests that the process of smoking and non-nicotine components of tobacco smoke mediate some of the effects of cigarette smoking. More research is needed on the comparative physical and mental effects of regular cigarettes and denicotinized cigarettes. Objectives: \- To compare the effects of complete abstinence or smoking denicotinized cigarettes with smoking nicotinized cigarettes on the following measures: (1) withdrawal symptoms and quality of sleep, (2) hormonal responses, (3) mood and cognitive performance, and (4) functional brain activity. Eligibility: \- Men between 18 and 50 years of age who are either current smokers (at least 15 cigarettes per day for at least 2 years) or nonsmoking volunteers. Design: * Participants will be divided into four groups: (1) nonsmokers, (2) smokers who receive nicotinized cigarettes, (3) smokers who receive denicotinized cigarettes, and (4) smokers who will abstain from cigarettes. * The study will last 16 days. Smokers will have 14 visits to the clinical center; nonsmokers will have 6 visits. From Day 6 to Day 14, current smokers will follow the smoking regimen assigned by the researchers (not smoking, smoking denicotinized cigarettes, or smoking nicotinized cigarettes). * Nonsmokers will have one day of trainin
Conditions Studied
Study Locations (1)
Maryland
- National Institute on Drug Abuse, Biomedical Research Center (BRC) — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2000-12-05 |
| Est. Completion | 2012-11-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01034384
The ClinicalTrials.gov registry entry for NCT01034384 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 119 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 1 condition, with Smoking Cessation 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: NCT01034384 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 NCT01034384 about?
NCT01034384 is a clinical study titled "Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence". Background: * Denicotinized cigarettes are similar to commercial cigarettes but contain and deliver virtually no nicotine. Denicotinized cigarettes are used as a control condition in smoking research, as a substitute treatment for nicotine dependence, and as a strategy to reduce incidence of nicoti...
What is the current status of trial NCT01034384?
This trial is currently completed. The enrollment target is 119 participants. The study started on 2000-12-05. Estimated completion is 2012-11-06.
What conditions does trial NCT01034384 study?
This clinical trial studies the following conditions: Smoking Cessation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01034384?
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 NCT01034384 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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