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The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers

This study has been completed.

Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00267813
  Purpose

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.


Condition Intervention
Nicotine Dependence
Drug: Bupropion (Zyban)

MedlinePlus related topics:   Smoking   

Drug Information available for:   Bupropion hydrochloride    Bupropion    Nicotine polacrilex    Nicotine tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:   The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Brain metabolic activity (FDG) in response to craving and neutral cues. [ Time Frame: 30-40 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective ratings of craving [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Enrollment:   24
Study Start Date:   July 2004
Study Completion Date:   October 2007
Primary Completion Date:   October 2007 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Bupropion (Zyban)
    1 tablet a day increasing to 2 tablets a day after a week
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.

  Eligibility
Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267813

Locations
Israel
Department of Nuclear Medicine    
      Tel Aviv, Israel, 64239

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Investigators
Principal Investigator:     Einat Even-Sapir, M.D, Ph.D     Tel-Aviv Sourasky Medical Center    
Principal Investigator:     Aviv M Weinstein, Ph.D     Tel-Aviv Sourasky Medical Center    
Study Director:     Hedva Lerman, M.D     Tel-Aviv Sourasky Medical Center    
  More Information


Responsible Party:   Sourasky Medical Center Tel Aviv ( Dr. Aviv M. Weinstein )
Study ID Numbers:   TASMC-O5-EE-065-CTIL
First Received:   December 20, 2005
Last Updated:   May 6, 2008
ClinicalTrials.gov Identifier:   NCT00267813
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Tel-Aviv Sourasky Medical Center:
craving  
nicotine  
imaging  
FDG  
PET
smoking
Bupropion

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Dopamine
Nicotine
Mental Disorders
Tobacco Use Disorder
Bupropion
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2008




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