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

Sponsor

Orexigen Therapeutics, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00563563

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Dependence Overweight Obesity	Drug: NB32 Behavioral: Ancillary therapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NB32 Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.	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.

Arm

Intervention/Treatment

Experimental: NB32

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

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.

Outcome Measures

Primary Outcome Measures

Assess rates of smoking cessation defined by continuous abstinence. [12 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key 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.

Key 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;
Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmacology Research Institute	Encino	California	United States	91316
2	Pharmacology Research Institute	Los Alamitos	California	United States	90720
3	Pharmacology Research Institute	Newport Beach	California	United States	92660