NCT00267813

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

3.3 years

First QC Date

December 20, 2005

Last Update Submit

May 6, 2008

Conditions

Nicotine Dependence

Keywords

cravingnicotineimagingFDGPETsmokingBupropion

Outcome Measures

Primary Outcomes (1)

  • Brain metabolic activity (FDG) in response to craving and neutral cues.

    30-40 minutes

Secondary Outcomes (1)

  • Subjective ratings of craving

    10 minutes

Interventions

Bupropion (Zyban)DRUG

1 tablet a day increasing to 2 tablets a day after a week

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cigarette smokers (over 1 pack a day)
  • Age 20-65, male-females

You may not qualify if:

  • Dependence on other substances
  • Psychiatric diagnosis
  • Neurological disorder
  • Obesity
  • Young persons
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • Weinstein A, Greif J, Yemini Z, Lerman H, Weizman A, Even-Sapir E. Attenuation of cue-induced smoking urges and brain reward activity in smokers treated successfully with bupropion. J Psychopharmacol. 2010 Jun;24(6):829-38. doi: 10.1177/0269881109105456. Epub 2009 Jul 31.

    PMID: 19648219DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Einat Even-Sapir, M.D, Ph.D

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Aviv M Weinstein, Ph.D

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Hedva Lerman, M.D

    Tel-Aviv Sourasky Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

July 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

IL(1)