A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
Public ClinicalTrials.gov record NCT00456521. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.
Study identification
- NCT ID
- NCT00456521
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 793 participants
Conditions and interventions
Conditions
Interventions
- Naltrexone SR 32 mg/ bupropion SR 360 mg/ day Drug
- Placebo Drug
- Intensive group lifestyle modification counseling Behavioral
Drug · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2007 (Type not available)
- Primary completion
- Dec 2008 (Actual)
- Completion
- Dec 2008 (Actual)
- Last update posted
- Dec 17, 2014
2007 – 2008
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Diego: Dept of Family & Preventive Medicine | La Jolla | California | 92093 | — |
| Center for Human Nutrition, University of Colorado Health Services Center | Denver | Colorado | 80220 | — |
| Univ. of Florida, College of Public Health, and Health Professions | Gainesville | Florida | 32611 | — |
| Washington Univ. Center for Human Nutrition | St Louis | Missouri | 63110 | — |
| New York Obesity Research Center, St. Luke's-Roosevelt Hospital Center | New York | New York | 10025 | — |
| Center for Weight and Eating Disorders, School of Med., University of Penn. | Philadelphia | Pennsylvania | 19104 | — |
| Center for Obesity Research and Education, Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Medical University of S. Carolina Weight Management Center | Charleston | South Carolina | 29425 | — |
| Behavioral Medicine Research Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00456521, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 17, 2014 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00456521 live on ClinicalTrials.gov.