Brain Reaction to Treatment of Nicotine Dependence

Nicotine Dependence Clinical Trial

Official title:

Neural Substrates of Treatment for Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108173
• Other study ID #: ADRD-018-02S
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2005
• Last updated: April 5, 2013
• Start date: October 2002
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2011
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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 Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Zyban

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-FA PET scan results	Brain activity and activation in response to cigarette-related cues	Within the first few weeks of study initiation	No