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NCT01034384 · ClinicalTrials.gov registry record

Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence

A clinical trial of Smoking Cessation, sponsored by National Institute on Drug Abuse (NIDA).

Completed
Registry status
119
Enrollment target
1
Study location

NCT01034384 is a study of Smoking Cessation that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 119 participants, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01034384, a study of Smoking Cessation, has completed, sponsored by National Institute on Drug Abuse (NIDA).

COMPLETED
Registry status
119 participants
Enrollment target
1
Study location

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

FieldValue
Enrollment Target 119 participants
Start Date 2000-12-05
Est. Completion 2012-11-06

What the Registry Record Tells You About NCT01034384

The ClinicalTrials.gov registry entry for NCT01034384 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (75% lower). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 0 interventions.

NCT01034384 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

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.

Who is sponsoring clinical trial NCT01034384?

This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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