SmokingNCT01719471
fMRI of Stress in Smoking Behavior
An observational study of Smoking, run by Yale University at 1 site in United States.
Trial summary
To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 30 tobacco dependent and 30 matched healthy controls who have never smoked will be recruited for this study
Who may be able to join
- age 18-50 years inclusive;
- able to read and write English;
- for women, being in follicular phase of menstrual cycle;
- 5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year; Non-smokers, no tobacco consumption for more than one year and never having used tobacco daily.
Who cannot join
- any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with possible exception of nicotine dependence) as determined by SCID interview;
- use of any psychoactive medication within past four weeks;
- any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk;
- IQ<70 based on past intelligence testing;
- any metal in body that would pose a risk with MRI; and
- claustrophobia that would interfere with MRI;
- alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;
- pregnancy for women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions
Read the detailed description
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different stress and 2 different tobacco cue scripts.
- Conditions
- Smoking
- 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 | Nicotine dependent individuals otherwise medically healthy | |
| Healthy | Medically healthy individuals who do not smoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
No outcome measures for this study, this is an imaging study only
Measured: Upon study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionDec 2014
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Marc Potenza, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719471
- Sponsor's protocol ID
- 0805003898
- Other IDs
- RL1AA017539
- Status last verified
- Dec 2014
- First submitted
- 29 Oct 2012
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI of Stress in Smoking Behavior
- ClinicalTrials.gov ID
- NCT01719471
- Acronym / sponsor ID
- 0805003898
- Conditions
- Smoking
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Nov 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.
To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions
Detailed description
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different stress and 2 different tobacco cue scripts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | –Nicotine dependent individuals otherwise medically healthy |
| Healthy | – | –Medically healthy individuals who do not smoke |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 tobacco dependent and 30 matched healthy controls who have never smoked will be recruited for this study
Key inclusion criteria (4 listed)
- age 18-50 years inclusive;
- able to read and write English;
- for women, being in follicular phase of menstrual cycle;
- 5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year; Non-smokers, no tobacco consumption for more than one year and never having used tobacco daily.
Key exclusion criteria (8 listed)
- any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with possible exception of nicotine dependence) as determined by SCID interview;
- use of any psychoactive medication within past four weeks;
- any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk;
- IQ<70 based on past intelligence testing;
- any metal in body that would pose a risk with MRI; and
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
No outcome measures for this study, this is an imaging study only
Time frame: Upon study completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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.
Marc Potenza, MD, PhD principal investigator
Yale 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 Smoking, 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 15 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
No outcome measures for this study, this is an imaging study only (time frame: Upon study completion). 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 Dec 2014.