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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT01034384

Public ClinicalTrials.gov record NCT01034384. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 4:51 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 training on the memory and thinking tasks that will be performed in the functional magnetic resonance imaging (fMRI) scanner, and will have 5 additional days of two fMRI scans per day (total of 10 fMRI scans). * Current smokers will have 2 days of training on the memory and thinking tasks that will be performed in the fMRI scanner, physical assessments on Day 3 and Day 6, and 5 days of two fMRI scans per day (total of 10 fMRI scans). * Participants in the complete abstinence group will be asked to resume smoking after the abstinence period and the denicotinized cigarettes group will resume nicotinized cigarettes on day 14. Participants can decline to resume smoking, and if desired they will be referred for smoking cessation treatment.

Study identification

NCT ID
NCT01034384
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
119 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 4, 2000
Primary completion
Not listed
Completion
Nov 5, 2012
Last update posted
Apr 4, 2018

2000 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institute on Drug Abuse, Biomedical Research Center (BRC) Baltimore Maryland 21224

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01034384, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 4, 2018 · Synced Sep 11, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01034384 live on ClinicalTrials.gov.

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