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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Institutes of Health (NIH) |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00507728 |
Recent advances in smoking cessation have focused on the use of Varenicline and antidepressants (e.g., Bupropion) for the treatment of nicotine dependence. While the efficacy of these treatments has been established in previous studies, we know little about how they work. The specific aims of this project are to assess the effects of these drugs on changes in emotional reactivity during cessation, to determine if these effects are moderated by genotype, and to determine whether emotional reactivity predicts time to relapse. A standardized laboratory assessment procedure, known as the acoustic startle probe, will be used to assess emotional reactivity. In this study, 375 smokers will be randomly assigned to receive Bupropion, Varenicline or placebo. Participants will complete three startle assessments consisting of the presentation of an acoustic stimulus (startle probe), immediately preceded by positive, negative or neutral emotional cues or smoking related stimuli. We hypothesize that the emotional reactivity of all smokers during cessation will be significantly less for those treated with either Varenicline or Bupropion in comparison to placebo. It is also hypothesized that emotional reactivity will be lower for those carrying the DRD2 A1 allele and using Varenicline vs. A1 smokers using either Bupropion or placebo. Homozygous A2s are expected to respond similarly to both drugs with higher levels of emotional reactivity being observed for placebo. We will also characterize other potential markers for neurotransmitter function (DRD4, DAT, SERT, NET) in terms of differences in both baseline emotional reactivity, and response to pharmacotherapy vs. the control. We hope to understand more fully how pharmacotherapies for smoking cessation affect emotional reactivity during cessation (nicotine withdrawal) and what role genetics may play in conferring an advantage to one treatment vs. another, through this mechanism.
Condition | Intervention | Phase |
Tobacco Use Disorder Smoking Cessation |
Drug: Bupropion Drug: Varenicline Drug: Placebo Behavioral: Smoking Cessation Counseling |
Phase II Phase III |
MedlinePlus related topics: | Smoking Smoking Cessation |
ChemIDplus related topics: | Varenicline Bupropion hydrochloride Bupropion |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Pharmacogenetics, Emotional Reactivity and Smoking |
Estimated Enrollment: | 375 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Bupropion
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Drug: Bupropion
150 mg PO Daily
Behavioral: Smoking Cessation Counseling
Counseling over 8 months and telephone support calls.
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2: Experimental
Varenicline
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Drug: Varenicline
0.5 mg PO Daily
Behavioral: Smoking Cessation Counseling
Counseling over 8 months and telephone support calls.
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3: Placebo Comparator
Placebo
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Drug: Placebo
Placebo by mouth for 12 weeks.
Behavioral: Smoking Cessation Counseling
Counseling over 8 months and telephone support calls.
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Cinciripini, PhD | 713-792-0919 |
United States, Texas | |||||
U.T.M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Paul Cinciripini, PhD |
M.D. Anderson Cancer Center |
National Institutes of Health (NIH) |
Principal Investigator: | Paul Cinciripini, PhD | U.T.M.D. Anderson Cancer Center |
UT MD Anderson Cancer Center Website 
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Responsible Party: | U.T.M.D. Anderson Cancer Center ( Paul Cinciripini, PhD/Professor ) |
Study ID Numbers: | 2003-1024 |
First Received: | July 25, 2007 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00507728 |
Health Authority: | United States: Institutional Review Board |
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