Brain Reaction to Treatment of Nicotine Dependence

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00108173

First received: April 14, 2005

Last updated: April 5, 2013

Last verified: April 2013

History of Changes

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:

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

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


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)

Arms	Assigned Interventions
Arm 1	Drug: Zyban

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 (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

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

VA Office of Research and Development

Investigators


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

More Information


Responsible Party:	VA Office of Research and Development
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

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

ClinicalTrials.gov processed this record on June 22, 2017

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