Genetic Differences in Limbic Activation Associated With Nicotine Withdrawal

NCT00664404 | Completed Phase 3 DMC

• 1 other identifier: 2005-0829
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

• To evaluate neural correlates associated with emotional processing during nicotine withdrawal preferentially involving the amygdala and associated areas within the corticolimbic and mesolimbic circuitry. We hypothesize that relative to a pre-quit baseline, post-quit nicotine withdrawal will result in increased activity to negative emotional cues, in contrast to other cues, in one or more areas of interest, and particularly in the right cerebral hemisphere.
• To determine if bupropion and varenicline moderate patterns of brain activation during post-quit nicotine withdrawal. We hypothesize that relative to placebo, bupropion and varenicline will attenuate the effects of post-quit nicotine withdrawal on emotional processing, reducing activation to negative emotional cues, relative to other cues, in one or more areas of interest, and particularly in the right cerebral hemisphere.
• To determine if genotype (DRD2 TaqA2 allele and the ins variant of the -141C ins/del DRD2) moderates patterns of brain activation during post-quit nicotine withdrawal.

Conditions

Smoking

Keywords

Smoking; Smoking Cessation; Nicotine Withdrawal; Nicotine Dependence; Neuroregulatory Effects; Magnetic Resonance Imaging; MRI

Outcome Measures

Primary Outcomes (1)

• Stimulus type (positive, negative, neutral, cigarette) by group (Bupropion/ Varenicline/Placebo)

  Pre-quit to 1-2 days post-quit

Study Arms (1)

fMRI

OTHER

Functional Magnetic Resonance Imaging (fMRI)

Other: Functional Magnetic Resonance Imaging (fMRI)

Interventions

Functional Magnetic Resonance Imaging (fMRI) OTHER

Functional Magnetic Resonance Imaging (fMRI)of the Brain, one session while smoking, and one session while abstinent from smoking (not smoking).

fMRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be a participant in 'Pharmacogenetics, Emotional Reactivity \& Smoking' (protocol 2003-1024).
• Both parents must be of European descent. The sample will be limited to individuals of European descent because the majority of the published work on the genes of interest has been limited to this racial group. This has been done mostly to prevent population stratification in genetic studies, since allele frequency differences often exist among groups with differing continents of origin.
• Age: 18 years or older

You may not qualify if:

• \. Contraindications for MR imaging procedures (e.g., subjects with certain types of implanted medical devices, such as pacemakers, neurostimulators, etc., or subjects who are claustrophobic).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Paul Cinciripini, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

US (1)