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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563563
• Other study ID #: NB-401
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2007
• Last updated: October 31, 2012
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: October 2012
• Source: Orexigen Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Obesity
• Overweight
• Tobacco Use Disorder

Intervention

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.

Behavioral:
• Ancillary therapy
During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.

Locations

Country	Name	City	State
United States	Pharmacology Research Institute	Encino	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Pharmacology Research Institute	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Orexigen Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess rates of smoking cessation defined by continuous abstinence.		12 weeks	No
Secondary	To assess the percent change from baseline in total body weight during the entire study		Baseline to endpoint	No
Secondary	To assess the rates of smoking cessation as measured by expired CO levels <10 ppm		12 and 24 weeks	No
Secondary	To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary		Baseline to endpoint	No