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Sponsored by: |
Orexigen Therapeutics, Inc |
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Information provided by: | Orexigen Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00563563 |
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and obese subjects.
Condition | Intervention | Phase |
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Nicotine Dependence Overweight Obesity |
Drug: Naltrexone SR/Bupropion SR |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | An Open-Label Study Assessing the Safety and Efficacy of Naltrexone Sustained Release (SR) in Combination With Bupropion Sustained Release (SR) in Overweight and Obese, Nicotine-Dependent Subjects |
Estimated Enrollment: | 30 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Drug: Naltrexone SR/Bupropion SR
All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks. During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
United States, California | |
Pharmacology Research Institute | |
Newport Beach, California, United States, 92660 | |
Pharmacology Research Institute | |
Los Alamitos, California, United States, 90720 | |
Pharmacology Research Institute | |
Encino, California, United States, 91316 |
Principal Investigator: | Nader Oskooilar, M.D., Ph.D. | Pharmacology Research Institute |
Responsible Party: | Orexigen Therapeutics, Inc ( Eduardo Dunayevich, MD ) |
Study ID Numbers: | NB-401 |
Study First Received: | November 21, 2007 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00563563 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Nicotine-dependence in overweight and obese subjects |
Dopamine Uptake Inhibitors Nicotine polacrilex Neurotransmitter Agents Nicotinic Agonists Narcotic Antagonists Psychotropic Drugs Disorders of Environmental Origin Overweight Cholinergic Agents Body Weight Signs and Symptoms Dopamine Mental Disorders |
Nicotine Substance-Related Disorders Nutrition Disorders Antidepressive Agents, Second-Generation Antidepressive Agents Obesity Tobacco Use Disorder Narcotics Naltrexone Bupropion Overnutrition Dopamine Agents Peripheral Nervous System Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Narcotic Antagonists Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Overweight Cholinergic Agents Body Weight Signs and Symptoms Nicotine |
Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Ganglionic Stimulants Nutrition Disorders Antidepressive Agents, Second-Generation Antidepressive Agents Obesity Tobacco Use Disorder Pharmacologic Actions Autonomic Agents Bupropion Naltrexone Dopamine Agents |