An observational study in Nicotine Dependence and Drug Abuse, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Institute on Drug Abuse (NIDA) · Observational
Background:
- Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research is needed to determine how different doses of nicotine and different intervals of receiving nicotine affect brain function. A greater understanding of nicotine's effect on the brain, as studied through functional magnetic resonance imaging (fMRI), may improve the effectiveness of smoking cessation therapies and treatments.
Objectives:
- To determine the effects of nicotine on brain function and chemistry in experienced cigarette smokers.
Eligibility:
- Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50 years of age.
Design:
Objective:
The overall goal of this protocol is to employ fMRI to define nicotine's neural pharmacokinetic and pharmacodynamic properties and neurochemical sites and mechanisms of action in experienced smokers and to correlate these with monoamine and nicotinic receptor genotypes as well as to determine behavioral correlates of nicotine during various conditions of delivery and regress behavioral correlates of nicotine administration against neuroanatomical sites of activation across subjects.
Study Population:
The study population will consist of adult (18-50 y.o.) non-treatment seeking smokers. Subjects must smoke at least 20 cigarettes per day for at least 1 year. They cannot be dependent on any drug or alcohol except nicotine and caffeine. In addition, they must be appropriate candidates for fMRI scanning.
Design:
The study is divided into 5 separate arms with a maximum of two arms being conducted at one time. The experimental arms explore the effect of intravenous nicotine delivery with respect to the following parameters: dosage, interval of delivery, rate of delivery and emotional processing. Specifically the arms are as follows: Experiment 1: 3 fMRI scan sessions each administering either 0.25, 0.75 and 1.5 mg IV nicotine; Experiment 2: 4 fMRI scan sessions administering two doses of 1.25 mg nicotine separated by 0.25, 0.75, 3 and 24 hours; Experiment 3: two injection series separated by 45 minutes, each injection series containing 5 rapid injections of 0.25 mg each, much like 5 puffs on a cigarette; Experiment 4: 3 fMRI sessions administering a single injection of 1.5 mg nicotine at 3 different rates- over 15, 60 or 120 seconds; and Experiment 5: 3 fMRI session administering 1.5 mg nicotine followed by exposure to either neutral, negative, or positive affect pictures. Since experimental arms are conducted in series, rather than in parallel, there are very few subjects common to more than one experimental arm.
Outcome Measures:
The relevant outcome measures in this study are the behavioral and physiological effects and the patterns of brain regions activated (or suppressed) following the intravenous administration of nicotine across varying doses, intervals, rates and the effect on these parameters of emotional processing in the context of nicotine of stimuli with different affective valence.
988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.
This study's planned enrollment of 128 is close to the median of 125 across 77 observational studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
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Subjects must be between the ages of 18 - 50 and in good health, based on history and physical exam, and must demonstrate that they are experienced nicotine users based upon urine nicotine/cotinine levels or exhaled CO.
EXCLUSION CRITERIA:
Subjects will be excluded if:
The record gives a start of Aug 2002 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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