SmokingNCT01840111
Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments (CameraCue)
A study testing Quit Smoking 6 hours and Quit Smoking 24 hours in people with Smoking and Healthy, run by Duke University at 1 site in United States.
Trial summary
The overarching goals of this proposal are to 1) identify the network of brain regions specifically activated by personal smoking environment cues and 2) to evaluate the effects of exposure to these cues on smoke self-administration and subjective reactivity. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Quit Smoking 6 hours and Quit Smoking 24 hours
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2014
- Phase
- Interventional
- 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
Who may be able to join
- generally healthy
- between the ages of 18 and 55
- smoking an average of 5 cigarettes per day for at least one year
- breath CO (carbon monoxide) level > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)
- no interest in quitting smoking for the duration of time required for the experiment
- right-handed as measured by a three-item scale used in our laboratory
- ability to identify 4 personal smoking and 4 personal non-smoking places
Who cannot join
- inability to attend all required experimental sessions
- significant health problems
- use of psychoactive medications
- use of smokeless tobacco
- current alcohol or drug abuse
- use of illegal drugs as measured by urine drug screen
- current use of nicotine replacement therapy or other smoking cessation treatment
- presence of conditions that would make MRI unsafe (e.g., pacemaker)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments
The overarching goals of this proposal are to 1) identify the network of brain regions specifically activated by personal smoking environment cues and 2) to evaluate the effects of exposure to these cues on smoke self-administration and subjective reactivity. The results of this study will inform the development of novel and more efficacious cue-exposures therapies targeted at helping smokers quit smoking and will provide novel mechanism information regarding the influence of environmental context on drug taking.
The investigator hypothesizes that cue-exposure treatments (CETs), in which drug use is prevented during exposure to drug cues (e.g. lit cigarette) have been of limited efficacy in part because they have not included cues representative of the contexts in which drug use occurs. By demonstrating that context cues have a differential and robust influence on brain and behavioral responses, we will have provided a substantial basis for including such stimuli in the context of treatment. At the same time, we will have identified novel mechanisms by which such stimuli promote continued drug use and relapse.
- Being tested
- Quit Smoking 6 hours, Quit Smoking 24 hours
- Keywords
- smoking environment, cue-exposure, cigarettes, nicotine, fMRI
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit Smoking 6 hoursBehavioural
participants will quit smoking 6 hours prior to the cue-exposure sessions
Quit Smoking 24 hoursBehavioural
participants will quit smoking 24 hours prior to the fMRI scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal between Personal Environment Pictures Relative to Standard Environment Pictures
During fMRI scanning participants will view pictures of personal and standard smoking and non-smoking environments; and also pictures of smoking-related and non-smoking related objects
Measured: following 24 hours of smoking abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph McClernon, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840111
- Sponsor's protocol ID
- Pro00033975
- Status last verified
- Jan 2017
- First submitted
- 23 Apr 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
McClernon FJ, Conklin CA, Kozink RV, Adcock RA, Sweitzer MM, Addicott MA, Chou YH, Chen NK, Hallyburton MB, DeVito AM. Hippocampal and Insular Response to Smoking-Related Environments: Neuroimaging Evidence for Drug-Context Effects in Nicotine Dependence. Neuropsychopharmacology. 2016 Feb;41(3):877-85. doi: 10.1038/npp.2015.214. Epub 2015 Jul 16.
PubMed 26179147
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments
- ClinicalTrials.gov ID
- NCT01840111
- Acronym / sponsor ID
- Pro00033975
- Keywords
- smoking environment, cue-exposure, cigarettes, nicotine, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Apr 2013 (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 goals of this proposal are to 1) identify the network of brain regions specifically activated by personal smoking environment cues and 2) to evaluate the effects of exposure to these cues on smoke self-administration and subjective reactivity. The results of this study will inform the development of novel and more efficacious cue-exposures therapies targeted at helping smokers quit smoking and will provide novel mechanism information regarding the influence of environmental context on drug taking.
The investigator hypothesizes that cue-exposure treatments (CETs), in which drug use is prevented during exposure to drug cues (e.g. lit cigarette) have been of limited efficacy in part because they have not included cues representative of the contexts in which drug use occurs. By demonstrating that context cues have a differential and robust influence on brain and behavioral responses, we will have provided a substantial basis for including such stimuli in the context of treatment. At the same time, we will have identified novel mechanisms by which such stimuli promote continued drug use and relapse.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- generally healthy
- between the ages of 18 and 55
- smoking an average of 5 cigarettes per day for at least one year
- breath CO (carbon monoxide) level > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)
- no interest in quitting smoking for the duration of time required for the experiment
Key exclusion criteria (8 listed)
- inability to attend all required experimental sessions
- significant health problems
- use of psychoactive medications
- use of smokeless tobacco
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quit Smoking 6 hoursparticipants will quit smoking 6 hours prior to the cue-exposure sessions | Behavioural | – |
| Quit Smoking 24 hoursparticipants will quit smoking 24 hours prior to the fMRI scan | Behavioural | – |
Primary outcome
Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal between Personal Environment Pictures Relative to Standard Environment Pictures
Time frame: following 24 hours of smoking abstinence
During fMRI scanning participants will view pictures of personal and standard smoking and non-smoking environments; and also pictures of smoking-related and non-smoking related objects
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 31 Jan 2017.
- Derived from this study: PubMed 26179147McClernon FJ, Conklin CA, Kozink RV, Adcock RA, Sweitzer MM, Addicott MA, Chou YH, Chen NK, Hallyburton MB, DeVito AM. Hippocampal and Insular Response to Smoking-Related Environments: Neuroimaging Evidence for Drug-Context Effects in Nicotine Dependence. Neuropsychopharmacology. 2016 Feb;41(3):877-85. doi: 10.1038/npp.2015.214. Epub 2015 Jul 16.
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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, Ph.D 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?
A study testing Quit Smoking 6 hours and Quit Smoking 24 hours in people with Smoking and Healthy, 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 7 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: finished, as of the sponsor's last update on 31 Jan 2017. 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?
Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal between Personal Environment Pictures Relative to Standard Environment Pictures (time frame: following 24 hours of smoking abstinence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840111, which also lists 1 linked publication.
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 31 Jan 2017; AzTrials last refreshed its copy on 2 Nov 2026.