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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840111
• Other study ID #: Pro00033975
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: January 30, 2017
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Smoking

Intervention

Behavioral:
• Quit Smoking 6 hours
participants will quit smoking 6 hours prior to the cue-exposure sessions
• Quit Smoking 24 hours
participants will quit smoking 24 hours prior to the fMRI scan

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	following 24 hours of smoking abstinence