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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00602927 |
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.
Condition | Intervention |
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Nicotine Dependence |
Drug: Varenicline Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation |
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Placebo
2mg/day
|
2: Active Comparator |
Drug: Varenicline
Varenicline 2mg/day
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Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Smoking Behavior
Alcohol/Drug Exclusion Criteria
Medication Exclusion Criteria
Current use or recent discontinuation (within last 14-days) of the following medications:
Any form of anti-psychotic medications that includes:
Medical Exclusion Criteria
General Exclusion
Contact: Riju Ray, MBBS, PhD | 215-746-7152 | rijuray@mail.med.upenn.edu |
Contact: Angela Pinto, MBA | 215-746-7171 | pintoa@mail.med.upenn.edu |
United States, Pennsylvania | |
Tobbaco Use Research Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Riju Ray, MBBS, PhD 215-746-7152 rijuray@mail.med.upenn.edu | |
Contact: Angela Pinto, MBA 215-746-7171 pintoa@mail.med.upenn.edu | |
Principal Investigator: Caryn Lerman, PhD |
Principal Investigator: | Caryn Lerman, PhD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Dr. Caryn Lerman ) |
Study ID Numbers: | 806623, GA30517A, TTURC P50 84718 |
Study First Received: | January 15, 2008 |
Last Updated: | January 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00602927 |
Health Authority: | United States: Institutional Review Board |
Nicotine polacrilex Smoking Nicotine Mental Disorders |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |