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Sponsored by: |
Pfizer |
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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 |
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Nicotine Dependence Nicotine Withdrawal |
Drug: Bupropion SR Drug: Varenicline |
Phase II Phase III |
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 |
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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 |
Principal Investigator: | Marc E Mooney, Ph.D. | University of Minnesota |
Responsible Party: | University of Minnesota ( Marc E. Mooney, Ph.D./Assistant Professor of Psychiatry ) |
Study ID Numbers: | GCRC 10047 |
Study First Received: | September 5, 2008 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00749658 History of Changes |
Health Authority: | United States: Federal Government |
Tobacco Nicotine Smoking Varenicline Bupropion Human laboratory study |
Stress tolerance Startle response Cognitive assessment Progressive ratio Stress tolerance Motivation |
Dopamine Uptake Inhibitors Nicotine polacrilex Neurotransmitter Agents Substance Withdrawal Syndrome Tobacco Use Disorder Nicotinic Agonists Psychotropic Drugs Stress Disorders of Environmental Origin Cholinergic Agents Varenicline |
Smoking Dopamine Mental Disorders Nicotine Bupropion Substance-Related Disorders Dopamine Agents Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Substance Withdrawal Syndrome Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Cholinergic Agents Nicotine Mental Disorders |
Therapeutic Uses Ganglionic Stimulants Substance-Related Disorders Antidepressive Agents, Second-Generation Antidepressive Agents Tobacco Use Disorder Pharmacologic Actions Autonomic Agents Bupropion Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |