Brain Reaction to Treatment of Nicotine Dependence

April 5, 2013 updated by: US Department of Veterans Affairs

Neural Substrates of Treatment for Nicotine Dependence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Drug: Zyban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-FA PET scan results
Time Frame: Within the first few weeks of study initiation
Brain activity and activation in response to cigarette-related cues
Within the first few weeks of study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Arthur L. Brody, MD, VA Greater Los Angeles Healthcare System, West LA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 14, 2005

First Submitted That Met QC Criteria

April 14, 2005

First Posted (Estimate)

April 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADRD-018-02S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe