Back to resultsBrain Reaction to Treatment of Nicotine Dependence
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zyban
Sponsored by
About this trial
This is an interventional diagnostic trial for Nicotine Dependence focused on measuring Position Emission Tomography (PET), Nicotine dependence, functional magnetic resonance imaging, cigarette cues
Eligibility Criteria
Inclusion Criteria: Heavy smoker, more than one pack per day Free of medical conditions or medications that affect brain activity Not pregnant Exclusion Criteria: Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions
Sites / Locations
- VA Greater Los Angeles Healthcare System, West LA
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
2-FA PET scan results
Brain activity and activation in response to cigarette-related cues
Secondary Outcome Measures
Full Information
NCT ID
NCT00108173
First Posted
April 14, 2005
Last Updated
April 5, 2013
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00108173
Brief Title
Brain Reaction to Treatment of Nicotine Dependence
Official Title
Neural Substrates of Treatment for Nicotine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study was to determine how the treatments for cigarette craving work.
Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.
Detailed Description
PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Position Emission Tomography (PET), Nicotine dependence, functional magnetic resonance imaging, cigarette cues
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Zyban
Primary Outcome Measure Information:
Title
2-FA PET scan results
Description
Brain activity and activation in response to cigarette-related cues
Time Frame
Within the first few weeks of study initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heavy smoker, more than one pack per day
Free of medical conditions or medications that affect brain activity
Not pregnant
Exclusion Criteria:
Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur L. Brody, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West LA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West LA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brain Reaction to Treatment of Nicotine Dependence
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