A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent
NCT00563563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2012-11-02
Summary
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.
Conditions
- Nicotine Dependence
- Overweight
- Obesity
Interventions
- DRUG
-
NB32
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.
- BEHAVIORAL
-
Ancillary therapy
During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
Sponsors & Collaborators
-
Orexigen Therapeutics, Inc
lead INDUSTRY
Principal Investigators
-
Nader Oskooilar, M.D., Ph.D. · Pharmacology Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2008-09-30
- Completion
- 2008-09-30
Countries
- United States
Study Locations
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