A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent

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”

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Primary Measures

• Assess rates of smoking cessation defined by continuous abstinence.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To assess the percent change from baseline in total body weight during the entire study
  • Time Frame: Baseline to endpoint
    Safety Issue?: No
• To assess the rates of smoking cessation as measured by expired CO levels <10 ppm
  • Time Frame: 12 and 24 weeks
    Safety Issue?: No
• To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary
  • Time Frame: Baseline to endpoint
    Safety Issue?: No

Key Inclusion Criteria:

• 1. Female and male subjects must be 18 to 65 years of age;
• 2. Have body mass index (BMI) greater than or equal to 27 and less than or equal to 45kg/m2;
• 3. Have smoked an average of at least 10 cigarettes/day in the preceding year, with < 3 month total abstinence period;
• 4. Self-reported level of motivation to stop smoking ≥ 7, on a scale of 1-to-10;
• 5. At least moderately concerned about gaining weight after quitting smoking
• 6. Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
• 7. Able to comply with all required study procedures and schedule;
• 8. Able to speak and read English;
• 9. Willing and able to give written informed consent.

Key Exclusion Criteria:

• 1. Obesity of known endocrine origin
• 2. Serious medical condition
• 3. History of drug or alcohol abuse or dependence
• 4. Use of excluded concomitant medications
• 5. History of surgical or device (e.g. gastric banding) intervention for obesity;
• 6. History or predisposition to seizures
• 7. Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
• 8. Planned surgical procedure that can impact the conduct of the study;
• 9. Use of investigational drug, device or procedure within 30 days prior to Screening;
• 10. Participation in any previous clinical trial conducted by Orexigen Therapeutics;
• 11. Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Orexigen Therapeutics, Inc Industry

Overall Clinical Trial Officials and Contacts

Nader Oskooilar, M.D., Ph.D. Principal Investigator Pharmacology Research Institute  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563563

Study ID Number: NB-401

ClinicalTrials.gov Identifier: NCT00563563

Health Authority: United States: Food and Drug Administration