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

Primary Purpose

Nicotine Dependence, Overweight, Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NB32
Ancillary therapy
Sponsored by
Orexigen Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine-dependence in overweight and obese subjects

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Pharmacology Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NB32

Arm Description

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

Outcomes

Primary Outcome Measures

Assess rates of smoking cessation defined by continuous abstinence.

Secondary Outcome Measures

To assess the percent change from baseline in total body weight during the entire study
To assess the rates of smoking cessation as measured by expired CO levels <10 ppm
To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary

Full Information

First Posted
November 21, 2007
Last Updated
October 31, 2012
Sponsor
Orexigen Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00563563
Brief Title
A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent
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 Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orexigen Therapeutics, Inc

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Overweight, Obesity
Keywords
Nicotine-dependence in overweight and obese subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NB32
Arm Type
Experimental
Arm Description
Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
Intervention Type
Drug
Intervention Name(s)
NB32
Other Intervention Name(s)
Contrave, Naltrexone SR 32 mg/Bupropion SR 360 mg daily
Intervention Description
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
Behavioral
Intervention Name(s)
Ancillary therapy
Intervention Description
During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
Primary Outcome Measure Information:
Title
Assess rates of smoking cessation defined by continuous abstinence.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To assess the percent change from baseline in total body weight during the entire study
Time Frame
Baseline to endpoint
Title
To assess the rates of smoking cessation as measured by expired CO levels <10 ppm
Time Frame
12 and 24 weeks
Title
To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary
Time Frame
Baseline to endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Oskooilar, M.D., Ph.D.
Organizational Affiliation
Pharmacology Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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