Smoking CessationNCT01034384
Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence
An observational study of Smoking Cessation, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Smoking Cessation
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2000to 6 Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants must be:
- Between the ages of 18-50.
- In good health.
- Right-handed.
- Free of past or present abuse and dependence on other substances (except nicotine).
- Able to abstain from alcohol for 24 hours before each experiment session and no more than 50 mg of caffeine (about 1/2 cup of coffee or a 12 oz cola) for 12 hours before each neuroimaging session.
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- Male.
- Smokers must be:
- 1. Regular smokers of greater than or equal to 15 cigarettes other than ultra-low nicotine cigarettes per day for at least two years with evidence of withdrawal symptoms when having stopped smoking for several hours (planes, theater, etc).
- Nonsmokers must:
- 1. Have smoked less than or equal to 5 cigarettes in their lifetime, and no cigarettes or any tobacco product in the past 5 years, and expired air CO < 8ppm.
- Smokers:
- regular cigarette smokers smoking greater than or equal to 10 cigarettes/day for at least 1 year
- no intention to reduce or quit tobacco use
- age between 18 and 45 years
- men
Who cannot join
- Participants will be excluded if they:
- Are not suitable to undergo an fMRI experiment due to implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology or claustrophobia.
- Have coagulopathies, history of or current superficial, or deep vein thrombosis, or musculoskeletal abnormalities restricting an individual s ability to lie flat for extended periods of time.
- Have HIV or Syphilis.
- Have any neurological illnesses to include, but not limited to, seizure disorders, migraine (>2/yr or on prophylaxis), multiple sclerosis, movement disorders, or history of significant head trauma, CVA, CNS tumor.
- Have other major medical illnesses likely to interfere with study results or safety of an individual during participation.
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- Hemoglobin < 10 g/dl
- White Blood Cell Count < 2400/microliters
- Liver Function Tests > 3 times normal
- Serum glucose > 200 mg/dl
- Urine protein > 2 plus
- Have any current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders.
- Regularly use any prescription, over-the-counter or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling.
- Are cognitively impaired or learning disabled.
- Significant cardiovascular or cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the detailed description
Objective:
To compare the effects of complete abstinence or smoking denicotinized research cigarettes to smoking ad libitum nicotinized research cigarettes on the following measures: withdrawal symptoms and quality of sleep; MAO-A and MAO-B activities; hormonal responses (HPA, HPT); mood, cognitive and psychometric performance; functional brain activity, and physiological responses.
Study Population:
Participants are 125 men who are at least 18 years old, report smoking at least 15 cigarettes per day, have not used any illicit drug except marijuana in the past year, have no history of drug or alcohol dependence, and have already experienced tobacco withdrawal symptoms when they had no access to cigarettes.
Design:
Smokers will be randomized into one of the following 3 groups: a) complete tobacco abstinence for 8 days; b) denicotinized research cigarettes for 8 days, or c) control group smoking nicotinized research cigarettes during the entire study (16 days). Because there are few studies comparing functional brain activity in smokers and nonsmokers, a group of nonsmokers will serve as a control group for the brain imaging studies.
Outcome Measures:
Withdrawal symptoms, mood, quality of sleep, cognitive performance, temperature, blood pressure and heart rate, MAO-A parameters: plasma DHPG (dihydroxyphenylglycol), HVA (homovanillic acid), 5HIAA (5-hydroxyindolacetic acid); MAO-B parameters: urinary excretion of phenylethylamine, platelet MAO-B activity; hormonal parameters: serum ACTH, cortisol, TSH, thyroxine, triiodothyronine; EEG; cigarette liking; expired air CO; and functional brain activity.
- Conditions
- Smoking Cessation
- Keywords
- fMRI, Smoking Withdrawal, Imaging, Memory, Mood
- Medical subject headings
- Smoking Cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective withdrawal symptoms, cognitive performance, vital signs, MAO-A and MAO-B parameters, hormonal parameters, EEG, cigarette liking, expired air CO, and functional brain activity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study start5 Dec 2000
- Study completion6 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen J Heishman, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034384
- Sponsor's protocol ID
- 999901357
- Other IDs
- 01-DA-N357
- Status last verified
- 6 Nov 2012
- First submitted
- 16 Dec 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence
- ClinicalTrials.gov ID
- NCT01034384
- Acronym / sponsor ID
- 999901357
- Conditions
- Smoking Cessation
- Keywords
- fMRI, Smoking Withdrawal, Imaging, Memory, Mood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 5 Dec 2000
- Study completion
- 6 Nov 2012
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
To compare the effects of complete abstinence or smoking denicotinized research cigarettes to smoking ad libitum nicotinized research cigarettes on the following measures: withdrawal symptoms and quality of sleep; MAO-A and MAO-B activities; hormonal responses (HPA, HPT); mood, cognitive and psychometric performance; functional brain activity, and physiological responses.
Study Population:
Participants are 125 men who are at least 18 years old, report smoking at least 15 cigarettes per day, have not used any illicit drug except marijuana in the past year, have no history of drug or alcohol dependence, and have already experienced tobacco withdrawal symptoms when they had no access to cigarettes.
Design:
Smokers will be randomized into one of the following 3 groups: a) complete tobacco abstinence for 8 days; b) denicotinized research cigarettes for 8 days, or c) control group smoking nicotinized research cigarettes during the entire study (16 days). Because there are few studies comparing functional brain activity in smokers and nonsmokers, a group of nonsmokers will serve as a control group for the brain imaging studies.
Outcome Measures:
Withdrawal symptoms, mood, quality of sleep, cognitive performance, temperature, blood pressure and heart rate, MAO-A parameters: plasma DHPG (dihydroxyphenylglycol), HVA (homovanillic acid), 5HIAA (5-hydroxyindolacetic acid); MAO-B parameters: urinary excretion of phenylethylamine, platelet MAO-B activity; hormonal parameters: serum ACTH, cortisol, TSH, thyroxine, triiodothyronine; EEG; cigarette liking; expired air CO; and functional brain activity.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Between the ages of 18-50.
- In good health.
- Right-handed.
- Free of past or present abuse and dependence on other substances (except nicotine).
- Able to abstain from alcohol for 24 hours before each experiment session and no more than 50 mg of caffeine (about 1/2 cup of coffee or a 12 oz cola) for 12 hours before each neuroimaging session.
Key exclusion criteria (15 listed)
- Are not suitable to undergo an fMRI experiment due to implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology or claustrophobia.
- Have coagulopathies, history of or current superficial, or deep vein thrombosis, or musculoskeletal abnormalities restricting an individual s ability to lie flat for extended periods of time.
- Have HIV or Syphilis.
- Have any neurological illnesses to include, but not limited to, seizure disorders, migraine (>2/yr or on prophylaxis), multiple sclerosis, movement disorders, or history of significant head trauma, CVA, CNS tumor.
- Have other major medical illnesses likely to interfere with study results or safety of an individual during participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective withdrawal symptoms, cognitive performance, vital signs, MAO-A and MAO-B parameters, hormonal parameters, EEG, cigarette liking, expired air CO, and functional brain activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Heishman, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective withdrawal symptoms, cognitive performance, vital signs, MAO-A and MAO-B parameters, hormonal parameters, EEG, cigarette liking, expired air CO, and functional brain activity.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.