Brain Reaction to Treatment of Nicotine Dependence

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00108173
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arm: 1
• Duration (Months): 104
• Patients Per Site Per Month: 1

Study Details

Study Description

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

• Study Type: Interventional
• 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: Oct 1, 2002
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1	Drug: Zyban

Outcome Measures

Primary Outcome Measures

1. 2-FA PET scan results [Within the first few weeks of study initiation]

   Brain activity and activation in response to cigarette-related cues

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California	United States	90073

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00108173
• Other Study ID Numbers: ADRD-018-02S
• First Posted: Apr 15, 2005
• Last Update Posted: Apr 9, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by US Department of Veterans Affairs: Position Emission Tomography (PET); Nicotine dependence; functional magnetic resonance imaging; cigarette cues
• Additional relevant MeSH terms: Tobacco Use Disorder

Study Results

No Results Posted as of Apr 9, 2013