Does Sweet Taste Potentiate Nicotine Cue Reactivity?

NCT02499757 | Completed Phase 1 DMC

• 2 other identifiers: 1408014434P50DA036151
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Keywords

Perception; brain response; nicotine; taste

Outcome Measures

Primary Outcomes (1)

• Change from Baseline on Rating: Liking

  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).

  2 days

Secondary Outcomes (1)

• percent signal change of nucleus accumbens from fMRI

  on average 2 weeks

Study Arms (4)

flavor and sweetener

EXPERIMENTAL

E-cigarette with a novel flavor and sweetener added

Device: flavor and sweetener

flavor and nicotine

EXPERIMENTAL

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

Device: flavor and nicotine

flavor, nicotine and sweetener

EXPERIMENTAL

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

Device: flavor, nicotine and sweetener

flavor

EXPERIMENTAL

E-cigarette with a novel flavor: without a sweetener and 12 mg nicotine added

Device: flavor

Interventions

flavor and sweetener DEVICE

maltol added as sweetener to e-cigarette with flavor

flavor and sweetener

flavor and nicotine DEVICE

12 mg of nicotine added to e-cigarette with flavor

flavor and nicotine

flavor, nicotine and sweetener DEVICE

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

flavor, nicotine and sweetener

flavor DEVICE

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

flavor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• right handed
• non-daily smoker
• english speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The John B Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

Related Publications (5)

• 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.

  PMID: 18053653 BACKGROUND

• 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.

  PMID: 24575993 BACKGROUND

• 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.

  PMID: 9134093 BACKGROUND

• 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.

  PMID: 23643837 BACKGROUND

• 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.

  PMID: 24042699 BACKGROUND

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dana M Small

  The John B. Pierce Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: July 16, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

US (1)