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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563563
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : November 2, 2012
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Overweight Obesity Drug: NB32 Behavioral: Ancillary therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Assess rates of smoking cessation defined by continuous abstinence. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. To assess the percent change from baseline in total body weight during the entire study [ Time Frame: Baseline to endpoint ]
  2. To assess the rates of smoking cessation as measured by expired CO levels <10 ppm [ Time Frame: 12 and 24 weeks ]
  3. To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary [ Time Frame: Baseline to endpoint ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563563

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
Principal Investigator: Nader Oskooilar, M.D., Ph.D. Pharmacology Research Institute

Responsible Party: Orexigen Therapeutics, Inc Identifier: NCT00563563     History of Changes
Other Study ID Numbers: NB-401
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Body Weight
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Sensory System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors