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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00563563
First received: November 21, 2007
Last updated: October 31, 2012
Last verified: October 2012

November 21, 2007
October 31, 2012
October 2007
September 2008   (final data collection date for primary outcome measure)
Assess rates of smoking cessation defined by continuous abstinence. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Assess rates of smoking cessation defined by continuous abstinence. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00563563 on ClinicalTrials.gov Archive Site
  • To assess the percent change from baseline in total body weight during the entire study [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]
  • To assess the rates of smoking cessation as measured by expired CO levels <10 ppm [ Time Frame: 12 and 24 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • To assess the percent change from baseline in total body weight during the entire study [ Time Frame: Baseline to endpoint ]
  • To assess the rates of smoking cessation as measured by expired CO levels <10 ppm [ Time Frame: 12 and 24 weeks ]
  • To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary [ Time Frame: Baseline to endpoint ]
Not Provided
Not Provided
 
A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent
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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nicotine Dependence
  • Overweight
  • Obesity
  • 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.
    Other Names:
    • Contrave
    • Naltrexone SR 32 mg/Bupropion SR 360 mg daily
  • Behavioral: Ancillary therapy
    During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
Experimental: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
Interventions:
  • Drug: NB32
  • Behavioral: Ancillary therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00563563
NB-401
No
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
Principal Investigator: Nader Oskooilar, M.D., Ph.D. Pharmacology Research Institute
Orexigen Therapeutics, Inc
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP