NCT01665560

Brief Summary

The overarching goal of this project is to understand how nicotine addiction interacts with feeding behaviors and brain representation of food reward. The current proposal is part of a larger effort to begin a program of research to elucidate similarities and differences in perception of, and behavioral and neural response to, food and cigarette aromas as a function of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute, chronic). A general hypothesis is that there are overlapping neural mechanisms governing food reward and cigarette reward in smokers and that this overlap includes incentive salience encoding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

4.1 years

First QC Date

August 2, 2012

Last Update Submit

August 9, 2012

Conditions

Keywords

smokingfMRIodorstaste

Outcome Measures

Primary Outcomes (1)

  • fMRI w/ taste and smell stimuli

    Subjects will be scanned on a 3T Trio magnet while tasting and smelling various food and non-food substances. Our primary outcome measure will be differential brain responses to taste and smell stimuli as a function of group (smokers vs. nonsmokers).

    1-2 hours

Study Arms (2)

Smokers--Currently Smoking

Individuals that are right handed, and not claustrophobic were recruited. This same group was used for the smoking-group and refrain from smoking was evaluated by CO2 evaluation. To be classified as smokers, they had to report smoking 3-10 cigarettes daily for at least the last year and have a carbon monoxide reading of CO \>10 ppm.

Non-Smoker

Healthy individuals meeting the inclusion criteria who claim to not smoke. This is confirmed w/ CO testing.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults in the New Haven, CT area.

You may qualify if:

  • Healthy
  • between the ages of 18-45
  • fMRI safe

You may not qualify if:

  • outside of the above age range
  • not able to have an fMRI (non-removable metal, pacemaker, etc)
  • medical diagnosis related to neurological problems, anxiety, psychiatric conditions
  • Did not refrain from smoking for the described time in the smoking group, or showed a CO2 level consistent with a smoker in the non-smoking group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John B Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva samples were obtained and are stored using a coded ID in a secure part of our facility

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dana M Small, PhD

    Yale & John B Pierce Laboratory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 15, 2012

Study Start

June 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations