An observational study in Smoking Cessation, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by National Institute on Drug Abuse (NIDA) · Observational
Background:
Objectives:
Eligibility:
Design:
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.
National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
All participants must be:
Smokers must be:
Nonsmokers must:
EXCLUSION CRITERIA:
Participants will be excluded if they:
Have other major medical illnesses likely to interfere with study results or safety of an individual during participation.
INCLUSION CRITERIA (Pilot Studies):
Smokers:
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.
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)