Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00267813
First received: December 20, 2005
Last updated: May 6, 2008
Last verified: May 2008
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Smoking
U.S. FDA Resources

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

No publications provided by Tel-Aviv Sourasky Medical Center

Additional 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
Study First Received: December 20, 2005
Last Updated: May 6, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013