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Sponsored by: |
Pfizer |
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00749658 |
The objective of this proposal is to elucidate effects of bupropion SR + varenicline on smoking-cessation related processes in early abstinence using a human laboratory model. A within-subjects design will be used to assess the additive effects of bupropion and varenicline in 48 treatment seeking smokers [bupropion SR (300 mg/day)+placebo, varenicline (2 mg/day+placebo, and bupropion SR (300 mg/day)+varenicline (2 mg/day)]. Outcomes include withdrawal and craving, cognition, stress tolerance, anxiety, the reinforcing effects of smoking, and smoking topography.
Hypotheses: We hypothesize that greatest treatment effects will be observed in the bupropion SR+varenicline group followed by varenicline+placebo and bupropion SR+placebo groups.
Condition | Intervention | Phase |
Nicotine Dependence Nicotine Withdrawal |
Drug: Bupropion SR Drug: Varenicline |
Phase II Phase III |
MedlinePlus related topics: | Smoking Stress |
Drug Information available for: | Varenicline Bupropion hydrochloride Bupropion Nicotine polacrilex Nicotine tartrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence |
Estimated Enrollment: | 48 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline
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Drug: Bupropion SR
Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.
Drug: Varenicline
Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.
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2: Active Comparator
Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline
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Drug: Bupropion SR
Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.
Drug: Varenicline
Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.
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3: Active Comparator
Order 1: Bupropion + Varenicline \Bupropion + Placebo Varenicline; Order 2: Bupropion+ Placebo Varenicline \Bupropion + Varenicline
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Drug: Bupropion SR
Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.
Drug: Varenicline
Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Females who are of childbearing potential must practice effective contraception and meet the following criteria:
Exclusion Criteria:
Unwillingness or inability to give written informed consent.
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Contact: Marc E Mooney, Ph.D. | 612-627-1822 | moon0078@umn.edu |
Contact: Andrew Oliver, B.A. | 612-627-4905 | oliv0190@umn.edu |
United States, Minnesota | |||||
University of Minnesota, Tobacco Use Research Center | |||||
Minneapolis, Minnesota, United States, 55414 |
Pfizer |
Principal Investigator: | Marc E Mooney, Ph.D. | University of Minnesota |
Tobacco Use Research Center 
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Responsible Party: | University of Minnesota ( Marc E. Mooney, Ph.D./Assistant Professor of Psychiatry ) |
Study ID Numbers: | GCRC 10047 |
First Received: | September 5, 2008 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00749658 |
Health Authority: | United States: Federal Government |
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