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Completed

NCT Number: NCT02499757

Does Sweet Taste Potentiate Nicotine Cue Reactivity?

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).

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The John B Pierce Laboratory

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

flavor and sweetener

Device

maltol added as sweetener to e-cigarette with flavor

flavor and nicotine

Device

12 mg of nicotine added to e-cigarette with flavor

flavor, nicotine and sweetener

Device

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

flavor

Device

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

Primary outcomes

  1. Change from Baseline on Rating: Liking

    Time frame: 2 days

    At baseline and 2 days post exposure, subjects will rate 'liking' using the general Labeled Hedonic Scale (LHS). The LHS is a vertical line scale with quasi-logarithmic spaced, with the label 'most imaginable dislike' in the bottom to 'most imaginable like' in the top, with the label 'neutral' in the middle (recoded to range of -100 to +100).

Secondary outcomes

  1. percent signal change of nucleus accumbens from fMRI

    Time frame: on average 2 weeks

    brain response in nucleus accumbens and hypothalamus (in percent signal

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: FNC-nicotine

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2015
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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