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

Orexigen Therapeutics, Inc1 site in 1 country30 target enrollmentOctober 2007

ConditionsNicotine Dependence Overweight Obesity

InterventionsNB32 Ancillary therapy

DrugsNB32

Overview

Phase: Phase 2
Intervention: NB32
Conditions: Nicotine Dependence
Sponsor: Orexigen Therapeutics, Inc
Enrollment: 30
Locations: 1
Primary Endpoint: Assess rates of smoking cessation defined by continuous abstinence.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

September 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Orexigen Therapeutics, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Obesity of known endocrine origin
•Serious medical condition
•History of drug or alcohol abuse or dependence
•Use of excluded concomitant medications
•History of surgical or device (e.g. gastric banding) intervention for obesity;
•History or predisposition to seizures
•Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
•Planned surgical procedure that can impact the conduct of the study;
•Use of investigational drug, device or procedure within 30 days prior to Screening;
•Participation in any previous clinical trial conducted by Orexigen Therapeutics;

Arms & Interventions

NB32

Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.

Intervention: NB32

NB32

Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.

Intervention: Ancillary therapy

Outcomes

Primary Outcomes

Assess rates of smoking cessation defined by continuous abstinence.

Time Frame: 12 weeks

Secondary Outcomes

To assess the percent change from baseline in total body weight during the entire study(Baseline to endpoint)
To assess the rates of smoking cessation as measured by expired CO levels <10 ppm(12 and 24 weeks)
To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary(Baseline to endpoint)