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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00563563
First received: November 21, 2007
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Nicotine Dependence
Overweight
Obesity
Drug: NB32
Behavioral: Ancillary therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Assess rates of smoking cessation defined by continuous abstinence. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the percent change from baseline in total body weight during the entire study [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]
  • To assess the rates of smoking cessation as measured by expired CO levels <10 ppm [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563563

Locations
United States, California
Pharmacology Research Institute
Encino, California, United States, 91316
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Nader Oskooilar, M.D., Ph.D. Pharmacology Research Institute
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00563563     History of Changes
Other Study ID Numbers: NB-401
Study First Received: November 21, 2007
Last Updated: October 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
Nicotine-dependence in overweight and obese subjects

Additional relevant MeSH terms:
Overweight
Tobacco Use Disorder
Body Weight
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Bupropion
Naltrexone
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014