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

Phase 2

Completed

• Conditions: Nicotine Dependence; Overweight; Obesity
• Interventions: Drug: NB32; Behavioral: Ancillary therapy

• Registration Number: NCT00563563
• Lead Sponsor: Orexigen Therapeutics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-23
• Study First Posted: 2007-11-26
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-25
• Disposition First Submitted QC: 2012-10-25
• Disposition First Posted: 2012-10-31
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NB32	NB32	Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
NB32	Ancillary therapy	Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.

Primary Outcome Measures

Name	Time	Method
Assess rates of smoking cessation defined by continuous abstinence.	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pharmacology Research Institute; 🇺🇸 Newport Beach, California, United States