Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments (CameraCue)

NCT ID: NCT01840111

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-07-31

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.

Conditions

Smoking; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Quit Smoking 6 hours

participants will quit smoking 6 hours prior to the cue-exposure sessions

Intervention Type: BEHAVIORAL

Quit Smoking 24 hours

participants will quit smoking 24 hours prior to the fMRI scan

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph McClernon, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26179147 (View on PubMed)

Other Identifiers

Pro00033975

Identifier Type: -

Identifier Source: org_study_id