NCT00108173

Brief Summary

The purpose of the study was to determine how the treatments for cigarette craving work. Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_1

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

October 1, 2002

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

4.5 years

First QC Date

April 14, 2005

Last Update Submit

April 5, 2013

Conditions

Nicotine Dependence

Keywords

Position Emission Tomography (PET)Nicotine dependencefunctional magnetic resonance imagingcigarette cues

Outcome Measures

Primary Outcomes (1)

  • 2-FA PET scan results

    Brain activity and activation in response to cigarette-related cues

    Within the first few weeks of study initiation

Study Arms (1)

Arm 1

OTHER
Drug: Zyban

Interventions

ZybanDRUG
Arm 1

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Heavy smoker, more than one pack per day
  • Free of medical conditions or medications that affect brain activity
  • Not pregnant

You may not qualify if:

  • Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Arthur L. Brody, MD

    VA Greater Los Angeles Healthcare System, West LA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Start

October 1, 2002

Primary Completion

April 1, 2007

Study Completion

June 1, 2011

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

US(1)