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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00267813
First Posted: December 21, 2005
Last Update Posted: May 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  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)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Subjective ratings of craving [ Time Frame: 10 minutes ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Aviv M. Weinstein, Sourasky Medical Center Tel Aviv
ClinicalTrials.gov Identifier: NCT00267813     History of Changes
Other Study ID Numbers: TASMC-O5-EE-065-CTIL
First Submitted: December 20, 2005
First Posted: December 21, 2005
Last Update Posted: May 7, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors