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

NCT00563563 | Completed Phase 2

• 1 other identifier: NB-401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Assess rates of smoking cessation defined by continuous abstinence.

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

NB32

EXPERIMENTAL

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

Drug: NB32; Behavioral: Ancillary therapy

Interventions

NB32 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.

Also known as: Contrave, Naltrexone SR 32 mg/Bupropion SR 360 mg daily

NB32

Ancillary therapy BEHAVIORAL

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

NB32

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Orexigen Therapeutics, Inc: lead

Study Sites (3)

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Overweight; Obesity

Interventions

bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nader Oskooilar, M.D., Ph.D.

  Pharmacology Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 2, 2012

Record last verified: 2012-10

Locations

US (3)