Clinical trial NCT01840111: Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments (CameraCue)
Official title: Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Healthy
Keywords: smoking environment
cue-exposure
cigarettes
nicotine
fMRI
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal between Personal Environment Pictures Relative to Standard Environment Pictures
timeFrame: following 24 hours of smoking abstinence
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph McClernon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.