Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence
|First Received Date ICMJE||December 16, 2009|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||December 5, 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01034384 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence|
|Official Title ICMJE||Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence|
- 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.
- 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.
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.
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.
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Smoking Cessation|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||125|
|Estimated Completion Date||November 6, 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All participants must be:
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).
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.
Participants will be excluded if they:
INCLUSION CRITERIA (Pilot Studies):
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01034384|
|Other Study ID Numbers ICMJE||999901357, 01-DA-N357|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 6, 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP