The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Bupropion (Zyban)
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring craving, nicotine, imaging, FDG, PET, smoking, Bupropion
Eligibility Criteria
Inclusion Criteria: Cigarette smokers (over 1 pack a day) Age 20-65, male-females Exclusion Criteria: Dependence on other substances Psychiatric diagnosis Neurological disorder Obesity Young persons Pregnant women
Sites / Locations
- Department of Nuclear Medicine
Outcomes
Primary Outcome Measures
Brain metabolic activity (FDG) in response to craving and neutral cues.
Secondary Outcome Measures
Subjective ratings of craving
Full Information
NCT ID
NCT00267813
First Posted
December 20, 2005
Last Updated
May 6, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00267813
Brief Title
The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers
Official Title
The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.
Detailed Description
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity after exposure to videotapes showing smoking and neutral scenes in Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking videotape and one with a neutral video separated by a week. So far we have compared the brain's metabolic activity in 6 abstinent smokers and 6 still smokers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
craving, nicotine, imaging, FDG, PET, smoking, Bupropion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bupropion (Zyban)
Intervention Description
1 tablet a day increasing to 2 tablets a day after a week
Primary Outcome Measure Information:
Title
Brain metabolic activity (FDG) in response to craving and neutral cues.
Time Frame
30-40 minutes
Secondary Outcome Measure Information:
Title
Subjective ratings of craving
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cigarette smokers (over 1 pack a day)
Age 20-65, male-females
Exclusion Criteria:
Dependence on other substances
Psychiatric diagnosis
Neurological disorder
Obesity
Young persons
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Even-Sapir, M.D, Ph.D
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aviv M Weinstein, Ph.D
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hedva Lerman, M.D
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Department of Nuclear Medicine
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
19648219
Citation
Weinstein A, Greif J, Yemini Z, Lerman H, Weizman A, Even-Sapir E. Attenuation of cue-induced smoking urges and brain reward activity in smokers treated successfully with bupropion. J Psychopharmacol. 2010 Jun;24(6):829-38. doi: 10.1177/0269881109105456. Epub 2009 Jul 31.
Results Reference
derived
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The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers
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