Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study (2023)


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Clinical Therapeutics

Volume 43, Issue 1,

January 2021

, Pages 112-122.e1

Author links open overlay panelCarlos M.GriloPhD12PersonEnvelopeJanet A.LydeckerPhD1Peter T.MorganMD, PhD13RalitzaGueorguievaPhD14



Binge-eating disorder (BED), the most prevalent eating disorder, is associated strongly with obesity and functional impairments. Few evidence-based treatments for BED exist; a pharmacotherapy effective in reducing both binge eating and weight needs to be identified. This placebo-controlled double-blind pilot RCT evaluated the acute effects of naltrexone+bupropion (NB) on BED with obesity and examined the longer-term effects through 6-month follow-up after the discontinuation of medication.


Twenty-two adult patients with BED were randomized to receive 12 weeks of double-blind treatment with fixed-dose NB (naltrexone+bupropion XL 50/300mg) or placebo. Independent (blinded) researcher–clinicians evaluated patients at major outcome time points (baseline, posttreatment, and 6-month follow-up after the treatment period); patients were also evaluated for the tracking of course/tolerability throughout treatments and at 3-month follow-up. Primary outcomes were changes from baseline in binge-eating frequency and percentage weight. Secondary outcomes were changes in eating-disorder psychopathology and depression.


A total of 22 patients were enrolled (86.4% women; mean age, 50.4 years), with 77.3% of patients completing treatments; completion rates (NB, 83.3%; placebo, 70.0%) and adverse events did not differ significantly between NB and placebo. Analyses revealed significant reductions from baseline in binge-eating, eating-disorder psychopathology, depression, and weight during treatment, but these changes with NB did not differ significantly from those with placebo. The percentage of patients who attained 3% weight loss was significantly greater with NB than with placebo (45.5% vs 0%); weight-loss and binge-eating reductions were significantly correlated in the group that received NB. At 6-month follow-up, outcomes remained improved relative to baseline, with no significant differences between NB and placebo.


The findings from this pilot RCT suggest that NB was well-tolerated in these patients with BED and comorbid obesity. Most outcomes were not statistically different between NB and placebo. A larger-scale, adequately powered RCT is needed for determining the efficacy of NB in the treatment of BED. identifier: NCT02317744.

(Video) Integrating Psychotherapy and Medication in the Treatment of Eating Disorders


Binge-eating disorder (BED) is characterized by recurrent binge eating (ie, eating unusually large quantities of food, accompanied by a feeling of loss of control), marked distress, and the absence of inappropriate weight-compensatory behaviors.1 BED, the most prevalent formal eating-disorder diagnosis,2 has been significantly associated with medical and psychiatric comorbidities,3 and functional impairments.2 BED has been associated strongly with obesity2 and with a heightened risk for obesity-related metabolic problems.4

Although controlled treatment research has provided empiric support for certain pharmacologic approaches,5 many patients do not cease binge eating or lose weight.6 Producing weight loss in patients with BED comorbid with obesity has been particularly challenging. The majority of treatment studies have reported little weight loss,7 and the weight losses reported in studies of treatments for BED are less than those in obesity without BED.8 Of the medications for BED tested to date and available on the market, only 2 have been found to significantly reduce both binge eating and weight. The use of topiramate, an antiseizure agent, has been associated with significantly reduced binge eating and weight relative to placebo9 and with significantly enhanced outcomes compared to placebo, when added to cognitive–behavioral therapy.10 The use of topiramate, however, has been associated with concerning adverse events and limited tolerability, leading to very high discontinuation rates.11

Lisdexamfetamine dimesylate, a prodrug stimulant and the sole medication that the US Food and Drug Administration (FDA) has approved for use in the treatment of BED, in addition to being associated with a significant reduction in binge eating relative to placebo, has been reported to reduce weight.12 Importantly, weight loss was examined as a safety measure rather than as a clinical outcome, and the FDA approval of lisdexamfetamine dimesylate includes a Limitation of Use specifying that it is not indicated or recommended for weight loss and noting that its safety and efficacy in the treatment of obesity have not been demonstrated. Thus, effective pharmacologic approaches to reducing both binge eating and weight in BED remains a pressing need. Such research should include follow-up assessments of longer-term outcomes after discontinuation of medications, which are sorely needed for informing clinicians about the durability of the outcomes and the risk for relapse.13 To date, follow-up assessments in randomized, controlled trials (RCTs) of pharmacotherapy-only for BED have been reported in only 2 studies, and both suggested high and rapid relapse rates.14,15

Although several FDA-approved weight-loss medications are currently available, to date none has been tested as a monotherapy for BED.13 The use of 1 specific agent, the combination of naltrexone + bupropion (NB), seems logical given the putative mechanisms of action relevant for reducing both binge eating and weight, per hypothesized effects on the brain regions involved in the regulation of food intake and weight, based, in turn, on the findings from research on the mechanisms of action of leptin.16 The anorectic effects of leptin result from its excitatory effects on pro-opiomelanocorin (POMC) neurons in the melanocortin system of the hypothalamus.17 Stimulated POMC signaling decreases food intake and increases energy expenditure, but is then inhibited by endogenous feedback.17 The combination of naltrexone + bupropion is thought to stimulate POMC neurons (bupropion) plus block endogenous feedback that inhibits POMC activity (naltrexone).16,18 Several double-blind RCTs have reported that NB was effective in promoting weight loss in patients with obesity.18, 19, 20, 21, 22 Naltrexone and bupropion have been marketed for many years and are now available as generic products. Fixed-dose combination extended-release tablets became available in 2014 as a branded product with FDA approval for use as an adjunct to a reduced-calorie diet and increased physical activity in long-term weight management in adults with obesity (or with a body mass index [BMI] of 27 or greater in the presence of weight-related comorbidity). The present double-blind pilot RCT evaluated the acute effects of NB delivered for 12 weeks and examined the longer-term effects through 6-month follow-up after the discontinuation of medication in patients with BED with obesity.

Section snippets


Participants were 22 consecutively assessed patients who met the criteria for BED and obesity. Respondents to media advertisements for the treatment study at a medical school program and who passed initial screening were assessed for eligibility during in-person evaluations. Eligibility criteria included an age of 18–65 years, full Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)1–defined criteria for BED, and a BMI of 30–50kg/m2. Exclusion criteria in this pilot

Randomization, Patients' Characteristics, and Completion/Follow-up Rates

Figure1 summarizes the flow of patients throughout the study. Of the 268 screened individuals, 40 were evaluated in person, and 22 met eligibility and were randomized to treatment. The mean (SD) age of the participants was 50.4 (8.8) years; BMI, 37.1 (5.9); 86.4% (n=19) were women; 72.7% (n=16) self-identified as white; and 86.4% (n=19) attended or finished college. The 2 treatment groups did not differ significantly with regard to demographic variables (age, sex, race/ethnicity,


This study was the first to evaluate the potential effectiveness of NB, a generic formulation of an FDA-approved weight-loss medication, in the treatment of BED in persons with obesity. The findings from this small-sample double-blind pilot RCT suggest that NB was well tolerated in these patients with BED and comorbid obesity. The NB and placebo groups did not statistically differ with regard to most outcomes. Patients receiving NB were significantly more likely than were those receiving


The findings from this pilot RCT suggest that NB was well tolerated in these patients with BED and comorbid obesity. NB and placebo did not statistically differ with regard to most outcomes. A larger, adequately powered RCT is needed for determining the efficacy of NB in the treatment of BED.

Author Contributions

C.M. Grilo provided conceptualization, methodology; validation; investigation; writing, editing, and final review of the manuscript; and visualization. J.A. Lydecker provided methodology; project administration; validation; formal analysis; investigation; writing, review, editing, and final review of the manuscript; and visualization. P.T. Morgan provided methodology; investigation; and writing, review, editing, and final review of the manuscript. R. Gueorguieva provided formal analysis and

Funding Support

This research was supported, in part, by National Institutes of Health grants R01 DK49587 and K24 DK070052 to CMG. The authors' research was also supported, in part, by National Institutes of Health grants K23 DK115893 to JAL, UL1 TR001863 to JAL, R01 DK114075, and R01 DK112771 to CMG. The funder played no role in the content of this article.


C.M. Grilo has received consultant's fees from Sunovion and Weight Watchers; honoraria for lectures, Continuing Medical Education activities, and presentations at scientific conferences; and royalties from Guilford Press and Taylor & Francis. R. Gueorguieva has received royalties from CRC Press, and consultant's fees from Cohen Veterans Bioscience. The authors have indicated that they have no conflicts of interest with regard to the content of this article.

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    • Neurobiological and neuropharmacological aspects of food addiction

      2022, Neuroscience and Biobehavioral Reviews

      This review aims to draw attention to current studies on syndromes related to food eating behavior, including food addiction, and to highlight the neurobiological and neuropharmacological aspects of food addiction toward the development of new therapies. Food addiction and eating disorders are influenced by several neurobiological factors. Changes in feeding behavior, food addiction, and its pharmacological therapy are related to complex neurobiological processes in the brain. Thus, it is not surprising that there is inconsistency among various individual studies. In this review, we assessed literature including both experimental and clinical studies regarding food addiction as a feeding disorder. We selected articles from animal studies, randomized clinical trials, meta-analyses, narrative, and systemic reviews given that, crucial quantitative data with a measure of neurobiological, neuropharmacological aspects and current therapies of food addiction as an outcome. Thus, the main goal to outline here is to investigate and discuss the association between the brain reward system and feeding behavior in the frame of food addiction in the light of current literature.

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      Emerging work indicates divergence in the neurobiologies of binge-eating disorder (BED) and obesity despite their frequent co-occurrence. This review highlights specific distinguishing aspects of BED, including elevated impulsivity and compulsivity possibly involving the mesocorticolimbic dopamine system, and discusses implications for differential therapeutics for BED.

      This narrative review describes epidemiologic, clinical, genetic, and preclinical differences between BED and obesity. Subsequently, this review discusses human neuroimaging work reporting differences in executive functioning, reward processing, and emotion reactivity in BED compared with obesity. Finally, on the basis of the neurobiology of BED, this review identifies existing and new therapeutic agents that may be most promising given their specific targets based on putative mechanisms of action relevant specifically to BED.

      BED is characterized by elevated impulsivity and compulsivity compared with obesity, which is reflected in divergent neurobiological characteristics and effective pharmacotherapies. Therapeutic agents that influence both reward and executive function systems may be especially effective for BED.

      Greater attention to impulsivity/compulsivity-related, reward-related, and emotion reactivity–related processes may enhance conceptualization and treatment approaches for patients with BED. Consideration of these distinguishing characteristics and processes could have implications for more targeted pharmacologic treatment research and interventions.

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