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Cited by 558Pharmacology and Obesity TreatmentEating Disorders and BehaviorsRegulation of Appetite and Obesity

Weight loss with naltrexone sr/bupropion sr combination therapy as an adjunct to behavior modification: the COR-BMOD trial

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Wadden, Thomas A., Foreyt, John P., Foster, Gary D., Hill, James O., Klein, Samuel, O'Neil, Patrick M., Perri, Michael G., Pi‐Sunyer, F. Xavier +5 more·2011·Obesity
DOI 10.1038/oby.2010.147PMC PMC4459776
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Abstract

This 56‐week, randomized, placebo‐controlled trial examined the efficacy and safety of naltrexone plus bupropion as an adjunct to intensive behavior modification (BMOD). A total of 793 participants (BMI = 36.5 ± 4.2 kg/m 2 ) was randomly assigned in a 1:3 ratio to: (i) placebo + BMOD ( N = 202); or (ii) naltrexone sustained‐release (SR, 32 mg/day), combined with bupropion SR (360 mg/day) plus BMOD (i.e., NB32 + BMOD; N = 591). Both groups were prescribed an energy‐reduced diet and 28 group BMOD sessions. Co‐primary end points were percentage change in weight and the proportion of participants who lost ≥5% weight at week 56. Efficacy analyses were performed on a modified intent‐to‐treat population (ITT; i.e., participants with ≥1 postbaseline weight while taking study drug (placebo + BMOD, N = 193; NB32 + BMOD, N = 482)). Missing data were replaced with the last observation obtained on study drug. At week 56, weight loss was 5.1 ± 0.6% with placebo + BMOD vs. 9.3 ± 0.4% with NB32 + BMOD ( P < 0.001). A completers analysis revealed weight losses of 7.3 ± 0.9% ( N = 106) vs. 11.5 ± 0.6% ( N = 301), respectively ( P < 0.001). A third analysis, which included all randomized participants, yielded losses of 4.9 ± 0.6 vs. 7.8 ± 0.4%, respectively ( P < 0.001). Significantly more NB32 + BMOD‐ vs. placebo + BMOD‐treated participants lost ≥5 and ≥10% of initial weight, and the former had significantly greater improvements in markers of cardiometabolic disease risk. NB32 + BMOD was generally well tolerated, although associated with more reports of nausea than placebo + BMOD. The present findings support the efficacy of combined naltrexone/bupropion therapy as an adjunct to intensive BMOD for obesity.

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  • Naltrexone/bupropion pooled data from COR trials show ~5% weight loss and reduced cravings.

    “Pooled data from COR trials show ~ 5% loss and reduced cravings [27, 75].”

    From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [75]

    The Results (co-primary end points; page unavailable) show that naltrexone/bupropion plus behavior modification produced weight loss, but this paper reports one COR trial, not pooled COR data; its reported mean loss was 9.3%, not approximately 5%. In the Results (food cravings and control of eating; page unavailable), craving scores fell in both groups, with no significant difference between them. Thus the paper does not establish that the medication reduced cravings relative to placebo. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • Phentermine/topiramate-extended release produced placebo-subtracted weight loss of about 8% to 9% in phase 3 randomized controlled trials that enrolled participants without type 2 diabetes.

    “Phentermine/topiramate-extended release (ER) resulted in placebo-subtracted weight loss of ~8% to 9% in phase 3 RCTs that enrolled participants without T2D.746–748”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [747]

    The Introduction and Results describe a phase 3 trial of naltrexone/bupropion plus behavior modification, not phentermine/topiramate ER. Searches for phentermine/topiramate and the claimed 8%–9% placebo-subtracted loss found no passage in our copy addressing that claim; the Results instead report 9.3% weight loss with naltrexone/bupropion versus 5.1% with placebo. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

  • Naltrexone plus bupropion extended-release reduces weight on average by about 7% (about 5% placebo-subtracted) and more than either agent alone.

    “Naltrexone plus bupropion extended-release reduces weight on average by ≈7% (≈5% placebo-subtracted) [51][52][53][54] and also more than either agent administered alone.55”

    From Approach to Obesity Treatment in Primary Care: A Review (2024) · cites this paper as [51]

  • In COR-I, COR-II, and COR-BMOD, percent weight loss with 32/360 mg naltrexone/bupropion for 56 weeks versus placebo was 6.1 vs 1.3%, 6.4 vs 1.2%, and 9.3 vs 5.1%, respectively.

    “The percent weight loss observed in patients taking 32/360 mg of naltrexone/bupropion for 56 weeks in COR-I, COR-II, and COR-BMOD as compared to those taking placebo in the same groups was 6.1 vs. 1.3%, 6.4 vs. 1.2%, and 9.3 vs. 5.1%, respectively [42–44].”

    From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [44]

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Research works printed but not linked: 1

  1. [26]Vivtrol (naltrexone) [package insert] 2009 Alkermes Cambridge, MA

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Authors
Wadden, T. A., Foreyt, J. P., Foster, G. D., Hill, J. O., Klein, S., O'Neil, P. M., Perri, M. G., Pi‐Sunyer, F. X., Rock, C. L., Erickson, J. S., Maier, H. N., Kim, D. D., & Dunayevich, E.
Affiliations
  • University of Pennsylvania (US)
  • Baylor College of Medicine (US)
  • Temple University (US)
  • University of Colorado Denver (US)
  • Washington University in St. Louis (US)
  • Medical University of South Carolina (US)
  • University of Florida Health (US)
  • University of California San Diego (US)
  • Orexigen Therapeutics (United States) (US)
Corresponding author
Wadden, Thomas A.
ORCID
Venue
Obesity
Publisher
Wiley
Published
2011-01
Volume
19
Issue
1
Pages
110-120
ISSN
  • 1930-7381 (ISSN-L)
  • 1930-739X
DOI
10.1038/oby.2010.147
PMC
PMC4459776
OpenAlex
W1997115741
Cited by
558
References
29
Citations by year
2026: 44 · 2025: 38 · 2024: 52 · 2023: 45 · 2022: 27 · 2021: 29 · 2020: 41 · 2019: 32 · 2018: 37 · 2017: 38 · 2016: 46 · 2015: 46 · 2014: 23 · 2013: 21 · 2012: 19
FWCI
13.85
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor, 614 d)
Locations
  • Obesity (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • Orexigen Therapeutics
  • National Institute on Aging (P30AG028740)
  • National Institute of Diabetes and Digestive and Kidney Diseases (P30DK026687, P30DK056341)
Topics
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Social Sciences › Psychology › Clinical Psychology › Eating Disorders and Behaviors
  • Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
Keywords
naltrexone, bupropion, combination pharmacotherapy, behavior modification, weight loss, sustained-release formulation, hypocaloric diet, cardiometabolic risk, nausea, drug safety
MeSH terms
Adult, Antidepressive Agents, Behavior Therapy, Combined Modality Therapy, Delayed-Action Preparations, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Naltrexone, Narcotic Antagonists, Obesity, Placebos, Weight Loss, Bupropion, Treatment Outcome, Chemotherapy, Adjuvant

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