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

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267813
• Other study ID #: TASMC-O5-EE-065-CTIL
• Status: Completed
• Phase: N/A
• First received: December 20, 2005
• Last updated: May 6, 2008
• Start date: July 2004
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

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

Locations

Country	Name	City	State
Israel	Department of Nuclear Medicine	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain metabolic activity (FDG) in response to craving and neutral cues.		30-40 minutes	No
Secondary	Subjective ratings of craving		10 minutes	No