Does Sweet Taste Potentiate Nicotine Cue Reactivity?

NCT ID: NCT02499757

Last Updated: 2020-03-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-11-30

Brief Summary

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The investigators' aim is to test the prediction that sweet taste perception enhances the ability of nicotine to induce neural plastic changes in brain reward circuits to increase the saliency, liking and brain reactivity to the sight and vaporized flavor of electronic cigarettes (e-cigarettes).

Detailed Description

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Alternative tobacco products are becoming increasingly available in the US market and are promoted as potentially less deleterious compared to cigarettes. These products are increasing in usage as either a substitution for cigarette smoking or in addition to smoking. One particular appeal is that they often combine nicotine with sweet taste and flavors, which are themselves reinforcing. The primary goal of this project is to determine if sweet taste can potentiate the reinforcing properties of nicotine. Similar to nicotine, cues predicting the availability of carbohydrates can stimulate intake, even in the absence of hunger. The investigators have developed a novel flavor-nutrient conditioning paradigm to study the reinforcing properties of carbohydrates. Novel flavors are paired with 0 or 113 kcal carbohydrate and increases in flavor-cue reactivity (change in liking and brain response) when later sampled in the absence of the carbohydrate provide a measure of the reinforcing potency. For smokers, the aroma of tobacco is a potent cue that can promote smoking behavior. Using a modified version of our conditioning paradigm, our specific aim is to test the prediction that sweet taste perception enhances the ability of nicotine to induce neural plastic changes in brain reward circuits to increase the saliency, liking and brain reactivity to the sight and vaporized flavor of electronic cigarettes (e-cigarettes). Participants will smoke e-cigarettes that contain nicotine and an unsweetened vaporized flavor, nicotine and a sweet vaporized flavor or only a sweet vaporized flavor (no nicotine). The investigators predict that response in the nucleus accumbens and hypothalamus to the sight and vaporized flavor of the e-cigarette that was paired with nicotine and sweet taste will be greater than the responses to the sight and vaporized flavors associated with the other e-cigarettes. The investigators further predict that liking and wanting will increase more for the sight and vaporized flavor associated with both nicotine and sweet taste. This finding would provide strong evidence that sweet taste potentiates the reinforcement potency of nicotine and could therefore promote use.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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flavor and sweetener

E-cigarette with a novel flavor and sweetener added

Group Type EXPERIMENTAL

flavor and sweetener

Intervention Type DEVICE

maltol added as sweetener to e-cigarette with flavor

flavor and nicotine

E-cigarette with a novel flavor and 12 mg nicotine added

Group Type EXPERIMENTAL

flavor and nicotine

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

flavor, nicotine and sweetener

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

flavor

Intervention Type DEVICE

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

Intervention Type DEVICE

flavor and nicotine

12 mg of nicotine added to e-cigarette with flavor

Intervention Type DEVICE

flavor, nicotine and sweetener

12 mg nicotine and maltol (sweetener) added to e-cigarette with flavor

Intervention Type DEVICE

flavor

flavored e-cigarette stand alone without added nicotine and maltol (sweetener)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* right handed
* non-daily smoker
* english speaking

Exclusion Criteria

* serious or unstable medical illness (e.g., cancer);
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 18053653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24575993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9134093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23643837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24042699 (View on PubMed)

Other Identifiers

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P50DA036151

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1408014434

Identifier Type: -

Identifier Source: org_study_id

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