Nicotine DependencePhase 2NCT00563563
A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent
A Phase 2 study testing NB32 and Ancillary therapy in people with Nicotine Dependence and Overweight, run by Orexigen Therapeutics, Inc at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence, Overweight, Obesity
- What is being tested?
- NB32 and Ancillary therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Able to comply with all required study procedures and schedule;
- Able to speak and read English;
- Willing and able to give written informed consent.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pharmacology Research Institute
Encino, California, 91316
Pharmacology Research Institute
Los Alamitos, California, 90720
Pharmacology Research Institute
Newport Beach, California, 92660
About this study
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
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
- Being tested
- NB32, Ancillary therapy
- Keywords
- Nicotine-dependence in overweight and obese subjects
- Medical subject headings
- Tobacco Use Disorder, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB32Drug
Also called Contrave, Naltrexone SR 32 mg/Bupropion SR 360 mg daily
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 therapyBehavioural
During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
| Study group | Role | What they receive |
|---|---|---|
| NB32 | Experimental | Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise. Receives: Drug: NB32; Behavioral: Ancillary therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess rates of smoking cessation defined by continuous abstinence.
Measured: 12 weeks
Secondary outcomes (3)
To assess the percent change from baseline in total body weight during the entire study
Measured: Baseline to endpoint
To assess the rates of smoking cessation as measured by expired CO levels <10 ppm
Measured: 12 and 24 weeks
To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary
Measured: Baseline to endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nader Oskooilar, M.D., Ph.D., Principal investigator, Pharmacology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563563
- Sponsor's protocol ID
- NB-401
- Status last verified
- Oct 2012
- First submitted
- 21 Nov 2007
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00563563
- Acronym / sponsor ID
- NB-401
- Conditions
- Nicotine Dependence, Overweight, Obesity
- Keywords
- Nicotine-dependence in overweight and obese subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NB32 | Experimental | Drug: NB32, Behavioral: Ancillary therapyNaltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NB32Also: Contrave, Naltrexone SR 32 mg/Bupropion SR 360 mg dailyAll 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. | Drug | NB32 |
| Ancillary therapyDuring the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise. | Behavioural | NB32 |
Primary outcome
Assess rates of smoking cessation defined by continuous abstinence.
Time frame: 12 weeks
3 secondary outcomes
To assess the percent change from baseline in total body weight during the entire study
Time frame: Baseline to endpoint
To assess the rates of smoking cessation as measured by expired CO levels <10 ppm
Time frame: 12 and 24 weeks
To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary
Time frame: Baseline to endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader Oskooilar, M.D., Ph.D. principal investigator
Pharmacology Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NB32 and Ancillary therapy in people with Nicotine Dependence and Overweight, run by Orexigen Therapeutics, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess rates of smoking cessation defined by continuous abstinence. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.