Magnetic Resonance Imaging, FunctionalNCT01665560
Neural, Behavioral and Physiological Correlates of Feeding in Humans
An observational study of Magnetic Resonance Imaging, Functional, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Functional
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults in the New Haven, CT area.
Who may be able to join
- Healthy
- between the ages of 18-45
- fMRI safe
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
John B Pierce Laboratory
New Haven, Connecticut, 06519
About this study
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.
Read the detailed description
Weight gain frequently follows smoking cessation. Fear of weight gain is cited as a key reason not to quit and actual weight gain is a primary reason for relapse, especially among women. Although the causes of weight gain following smoking cessation are complex, increased caloric intake is recognized as one of the primary sources. One explanation for increased caloric intake is that, there are common neural mechanisms for food and cigarette reward and hence food reward can substitute for cigarette reward and vice versa. An alternative explanation for weight gain following smoking cessation is that there is an overall decrease in brain reward function during nicotine withdrawal, which leads to a decrease in the reward value of food and consequent increase in intake to maintain the total amount of reward obtained by food. The success of the proposed studies relies upon our ability to deliver odorants in the fMRI scanner and to measure neural activation in regions such as the amygdala, which are susceptible to inhomogeneity artifacts.
- Conditions
- Magnetic Resonance Imaging, Functional
- Keywords
- smoking, fMRI, odors, taste
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJun 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance Imaging, FunctionalStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana M Small, PhD, Principal investigator, Yale & John B Pierce Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665560
- Sponsor's protocol ID
- 0505027690
- Status last verified
- Aug 2012
- First submitted
- 2 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural, Behavioral and Physiological Correlates of Feeding in Humans
- ClinicalTrials.gov ID
- NCT01665560
- Acronym / sponsor ID
- 0505027690
- Conditions
- Magnetic Resonance Imaging, Functional
- Keywords
- smoking, fMRI, odors, taste
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Weight gain frequently follows smoking cessation. Fear of weight gain is cited as a key reason not to quit and actual weight gain is a primary reason for relapse, especially among women. Although the causes of weight gain following smoking cessation are complex, increased caloric intake is recognized as one of the primary sources. One explanation for increased caloric intake is that, there are common neural mechanisms for food and cigarette reward and hence food reward can substitute for cigarette reward and vice versa. An alternative explanation for weight gain following smoking cessation is that there is an overall decrease in brain reward function during nicotine withdrawal, which leads to a decrease in the reward value of food and consequent increase in intake to maintain the total amount of reward obtained by food. The success of the proposed studies relies upon our ability to deliver odorants in the fMRI scanner and to measure neural activation in regions such as the amygdala, which are susceptible to inhomogeneity artifacts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults in the New Haven, CT area.
Key inclusion criteria (3 listed)
- Healthy
- between the ages of 18-45
- fMRI safe
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fMRI w/ taste and smell stimuli
Time frame: 1-2 hours
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Related trials for Magnetic Resonance Imaging, Functional
RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Recruiting
Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3
Healthy Volunteers
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana M Small, PhD principal investigator
Yale & John B Pierce Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging, Functional, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI w/ taste and smell stimuli (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.