Brain Reaction to Treatment of Nicotine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108173
First received: April 14, 2005
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: Zyban
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Neural Substrates of Treatment for Nicotine Dependence

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 2-FA PET scan results [ Time Frame: Within the first few weeks of study initiation ] [ Designated as safety issue: No ]
    Brain activity and activation in response to cigarette-related cues


Enrollment: 104
Study Start Date: October 2002
Study Completion Date: June 2011
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108173

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Arthur L. Brody, MD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108173     History of Changes
Other Study ID Numbers: ADRD-018-02S
Study First Received: April 14, 2005
Last Updated: April 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Position Emission Tomography (PET)
Nicotine dependence
functional magnetic resonance imaging
cigarette cues

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014