Official Title: “The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study

Study Primary Completion Date: October 2007

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.

Intervention(s) in this Clinical Trial

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

Primary Measures

• Brain metabolic activity (FDG) in response to craving and neutral cues.
  • Time Frame: 30-40 minutes
    Safety Issue?: No

Secondary Measures

• Subjective ratings of craving
  • Time Frame: 10 minutes
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Overall Clinical Trial Officials and Contacts

Einat Even-Sapir, M.D, Ph.D Principal Investigator Tel-Aviv Sourasky Medical Center  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00267813

Study ID Number: TASMC-O5-EE-065-CTIL

ClinicalTrials.gov Identifier: NCT00267813

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration