Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2015-05-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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flavor and sweetener
E-cigarette with a novel flavor and sweetener added
flavor and sweetener
maltol added as sweetener to e-cigarette with flavor
flavor and nicotine
E-cigarette with a novel flavor and 12 mg nicotine added
flavor and nicotine
12 mg of nicotine added to e-cigarette with flavor
flavor, nicotine and sweetener
E-cigarette with a novel flavor, sweetener, and 12 mg nicotine added
flavor, nicotine and sweetener
12 mg nicotine and maltol (sweetener) added to e-cigarette with flavor
flavor
E-cigarette with a novel flavor: without a sweetener and 12 mg nicotine added
flavor
flavored e-cigarette stand alone without added nicotine and maltol (sweetener)
Interventions
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flavor and sweetener
maltol added as sweetener to e-cigarette with flavor
flavor and nicotine
12 mg of nicotine added to e-cigarette with flavor
flavor, nicotine and sweetener
12 mg nicotine and maltol (sweetener) added to e-cigarette with flavor
flavor
flavored e-cigarette stand alone without added nicotine and maltol (sweetener)
Eligibility Criteria
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Inclusion Criteria
* non-daily smoker
* english speaking
Exclusion Criteria
* past or current history of alcoholism or consistent drug use;
* current and history of major psychiatric illness as defined by the DSM-IV criteria including eating disorders,
* medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.) and any psychoactive drugs or anti-obesity agents;
* history of major head trauma with loss of consciousness;
* ongoing pregnancy;
* known taste or smell dysfunction;
* a diagnosis of diabetes;
* any known allergies or sensitivity, including to food, vapors or odors;
* pregnant or nursing women,
* history of metalworking, injury with shrapnel or metal slivers, and major surgery;
* history of pacemaker or neurostimulator implantation m) asthma, chronic obstructive pulmonary disease, bronchitis or any other lung disease.
18 Years
45 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Dana M Small
Role: PRINCIPAL_INVESTIGATOR
The John B. Pierce Laboratory
Locations
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The John B Pierce Laboratory
New Haven, Connecticut, United States
Countries
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References
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Backinger CL, Fagan P, O'Connell ME, Grana R, Lawrence D, Bishop JA, Gibson JT. Use of other tobacco products among U.S. adult cigarette smokers: prevalence, trends and correlates. Addict Behav. 2008 Mar;33(3):472-89. doi: 10.1016/j.addbeh.2007.10.009. Epub 2007 Nov 4.
Drummond MB, Upson D. Electronic cigarettes. Potential harms and benefits. Ann Am Thorac Soc. 2014 Feb;11(2):236-42. doi: 10.1513/AnnalsATS.201311-391FR.
Fedoroff IC, Polivy J, Herman CP. The effect of pre-exposure to food cues on the eating behavior of restrained and unrestrained eaters. Appetite. 1997 Feb;28(1):33-47. doi: 10.1006/appe.1996.0057.
de Araujo IE, Lin T, Veldhuizen MG, Small DM. Metabolic regulation of brain response to food cues. Curr Biol. 2013 May 20;23(10):878-83. doi: 10.1016/j.cub.2013.04.001. Epub 2013 May 2.
Carpenter MJ, Saladin ME, Larowe SD, McClure EA, Simonian S, Upadhyaya HP, Gray KM. Craving, cue reactivity, and stimulus control among early-stage young smokers: effects of smoking intensity and gender. Nicotine Tob Res. 2014 Feb;16(2):208-15. doi: 10.1093/ntr/ntt147. Epub 2013 Sep 16.
Other Identifiers
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1408014434
Identifier Type: -
Identifier Source: org_study_id
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