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

NCT ID: NCT00563563

Last Updated: 2012-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-09-30

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.

Conditions

Nicotine Dependence; Overweight; Obesity

Keywords

Nicotine-dependence in overweight and obese subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NB32

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

Group Type: EXPERIMENTAL

NB32

Intervention Type: DRUG

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.

Ancillary therapy

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DRUG

Ancillary therapy

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Contrave; Naltrexone SR 32 mg/Bupropion SR 360 mg daily

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orexigen Therapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nader Oskooilar, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pharmacology Research Institute

Locations

Pharmacology Research Institute

Encino, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Pharmacology Research Institute

Newport Beach, California, United States

Countries

United States

Other Identifiers

NB-401

Identifier Type: -

Identifier Source: org_study_id