Brain Reaction to Treatment of Nicotine Dependence
This study has been completed.
Sponsor:
VA Office of Research and Development
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
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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 VA Office of Research and Development:
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) |
| 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) |
| 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
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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
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 |
| Health Authority: | United States: Federal Government |
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 September 30, 2016