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Brain Reaction to Treatment of Nicotine Dependence

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ClinicalTrials.gov Identifier: NCT00108173
Recruitment Status : Completed
First Posted : April 15, 2005
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Zyban Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neural Substrates of Treatment for Nicotine Dependence
Study Start Date : October 2002
Actual Primary Completion Date : April 2007
Actual Study Completion Date : June 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Arm 1 Drug: Zyban


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108173


Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Arthur L. Brody, MD VA Greater Los Angeles Healthcare System, West LA
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00108173     History of Changes
Other Study ID Numbers: ADRD-018-02S
First Posted: April 15, 2005    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013

Keywords provided by VA Office of Research and Development:
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
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action