HealthyMPVSNCT00736203
Memory and Picture Viewing Study
An observational study of Healthy and Brain Reactivity of Non-smokers Undergoing fMRI Scanning, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to obtain a database of brain function from a sample of non-smokers while they do tasks in an MRI (magnetic resonance imaging) machine. Our hypothesis is that among nonsmokers, reactivity to smoking cues will be highly similar to control cues but may vary as a function of attitudes toward… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Brain Reactivity of Non-smokers Undergoing fMRI Scanning
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: generally healthy, right-handed non-smokers, between the ages of 18-55, having smoked less than 50 cigarettes in their lifetime
Who may be able to join
- generally healthy
- right-handed non-smokers
- between the ages of 18-55
- an expired CO concentration of 5 ppm or less; or a negative urine cotinine test of 100 ng/mL or less (to confirm a non-smoker)
- having smoked < 50 cigarettes in their lifetime
Who cannot join
- inability to attend all sessions
- significant health problems (hypertension, emphysema, seizure disorder, history of significant heart problems)
- use of psychoactive medications
- use of any tobacco or nicotine containing products
- current alcohol or drug abuse
- use of illegal drugs as measure by a urine drug screen
- presence of conditions that would make MRI unsafe (pacemaker, metallic implants
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to obtain a database of brain function from a sample of non-smokers while they do tasks in an MRI (magnetic resonance imaging) machine. Our hypothesis is that among nonsmokers, reactivity to smoking cues will be highly similar to control cues but may vary as a function of attitudes toward smoking and/or family history of smoking. We also hypothesize that brain activity during the n-back task will be more similar to data collected during this task when smokers are not abstinent.
Read the detailed description
Thirty six non-smokers will undergo functional magnetic resonance imaging (fMRI) scanning. During scanning participants will complete the n-back task-a measure of working memory-and the cue-reactivity task-a measure of responses to smoking cues. Before scanning, participants will complete a training session where they will be familiarized with the tasks.
All participants will have to pass a screening visit in order to be included in the study.
- Keywords
- fMRI, non-smokers
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 |
|---|---|---|
| A | non-smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain reactivity
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Duke 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Joseph McClernon, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736203
- Sponsor's protocol ID
- Pro00008250
- Acronym
- MPVS
- Status last verified
- Jan 2013
- First submitted
- 13 Aug 2008
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory and Picture Viewing Study
- ClinicalTrials.gov ID
- NCT00736203
- Acronym / sponsor ID
- MPVS / Pro00008250
- Keywords
- fMRI, non-smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Aug 2008 (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 purpose of this study is to obtain a database of brain function from a sample of non-smokers while they do tasks in an MRI (magnetic resonance imaging) machine. Our hypothesis is that among nonsmokers, reactivity to smoking cues will be highly similar to control cues but may vary as a function of attitudes toward smoking and/or family history of smoking. We also hypothesize that brain activity during the n-back task will be more similar to data collected during this task when smokers are not abstinent.
Detailed description
Thirty six non-smokers will undergo functional magnetic resonance imaging (fMRI) scanning. During scanning participants will complete the n-back task-a measure of working memory-and the cue-reactivity task-a measure of responses to smoking cues. Before scanning, participants will complete a training session where they will be familiarized with the tasks.
All participants will have to pass a screening visit in order to be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –non-smokers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- generally healthy, right-handed non-smokers, between the ages of 18-55, having smoked less than 50 cigarettes in their lifetime
Key inclusion criteria (5 listed)
- generally healthy
- right-handed non-smokers
- between the ages of 18-55
- an expired CO concentration of 5 ppm or less; or a negative urine cotinine test of 100 ng/mL or less (to confirm a non-smoker)
- having smoked < 50 cigarettes in their lifetime
Key exclusion criteria (7 listed)
- inability to attend all sessions
- significant health problems (hypertension, emphysema, seizure disorder, history of significant heart problems)
- use of psychoactive medications
- use of any tobacco or nicotine containing products
- current alcohol or drug abuse
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
brain reactivity
Time frame: 3 weeks
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 7 Feb 2013.
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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.
Joseph McClernon, PhD principal investigator
Duke University
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 Healthy and Brain Reactivity of Non-smokers Undergoing fMRI Scanning, run by Duke 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 5 inclusion and 7 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 7 Feb 2013. 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?
brain reactivity (time frame: 3 weeks). 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 7 Feb 2013.