- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01840111
Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments (CameraCue)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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
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following 24 hours of smoking abstinence
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph McClernon, Ph.D, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00033975
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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