Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial

Grilo, Carlos M.; Lydecker, Janet A.; Fineberg, Sarah K.; Moreno, Jorge O; Ivezaj, Valentina; Gueorguieva, Ralitza

doi:10.1176/appi.ajp.20220267

Cited by 41 publications

(51 citation statements)

References 39 publications

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“…Participant flow through this randomized controlled trial (RCT) testing CBT versus no‐CBT in addition to continuing double‐blinded pharmacotherapy from Stage 1 initial acute trial (either naltrexone/bupropion (NB) or placebo) for patients with binge‐eating disorder who were non‐responders to acute treatments (Stage 1). Stage 1 treatment ( N = 136) was a RCT testing naltrexone/bupropion and behavioral weight loss (BWL), alone and together, using a 2 × 2 balanced factorial design, described previously (Grilo et al, 2022). Of the 136 participants receiving Stage 1 treatments, 38 were categorized as treatment non‐responders and were eligible for this Stage 2 trial for non‐responders.…”

Section: Methodsmentioning

confidence: 99%

“…Pharmacotherapy . Pharmacotherapy involved continuing the double‐blind medication (naltrexone/bupropion or placebo) from the acute Stage 1 treatment trial (Grilo et al, 2022). Naltrexone/bupropion combination full dosing comprised naltrexone‐sustained‐release (32 mg/day) plus bupropion‐sustained‐release (360 mg/day) as in previous trials with obesity (Greenway et al, 2010; Wadden et al, 2011).…”

Section: Methodsmentioning

confidence: 99%

“…Taken together, the field needs controlled research on treatments for non‐responders to acute treatments for BED. This report describes a prospective, randomized controlled test of the efficacy of CBT for patients with BED comorbid with obesity who failed to respond to acute “generalist” treatments delivered in a randomized double‐blind placebo‐controlled trial (Grilo et al, 2022). Specifically, the acute treatment trial tested naltrexone/bupropion and behavioral therapy, alone and combined, for BED comorbid with obesity (Grilo et al, 2022).…”

Section: Overall No Cbt Cbt N = 31 N = 13 N = 18 Test Statistic P ...mentioning

confidence: 99%

“…This report describes a prospective, randomized controlled test of the efficacy of CBT for patients with BED comorbid with obesity who failed to respond to acute “generalist” treatments delivered in a randomized double‐blind placebo‐controlled trial (Grilo et al, 2022). Specifically, the acute treatment trial tested naltrexone/bupropion and behavioral therapy, alone and combined, for BED comorbid with obesity (Grilo et al, 2022). The putative mechanisms of naltrexone/bupropion combination, an FDA‐approved medication for the treatment of obesity (Yanovski & Yanovski, 2015), are relevant for BED.…”

Section: Overall No Cbt Cbt N = 31 N = 13 N = 18 Test Statistic P ...mentioning

confidence: 99%

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Cognitive‐behavioral therapy for binge‐eating disorder for non‐responders to initial acute treatments: Randomized controlled trial

Grilo

Lydecker

Gueorguieva

2023

Intl J Eating Disorders

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ObjectiveCertain treatments have demonstrated acute efficacy for binge‐eating disorder (BED) but many patients who receive “evidence‐based” interventions do not derive sufficient benefit. Given the dearth of controlled research examining treatments for patients who fail to respond to initial interventions, this study tested the efficacy of cognitive‐behavioral therapy (CBT) for patients with BED who do not respond to initial acute treatments.MethodsProspective randomized double‐blind placebo‐controlled single‐site trial, conducted August 2017–December 2021, tested 16‐weeks of therapist‐led CBT for non‐responders to initial treatment (naltrexone/bupropion and/or behavioral therapy) for BED with obesity. Thirty‐one patients (mean age 46.3 years, 77.4% women, 80.6% White, mean BMI 38.99 kg/m2) who were non‐responders to initial acute treatments were randomized to CBT (N = 18) or no‐CBT (N = 13), in addition to continuing double‐blinded pharmacotherapy. Independent assessments were performed at baseline, throughout treatment, and posttreatment; 83.9% completed posttreatment assessments.ResultsIntention‐to‐treat remission rates were significantly higher for CBT (61.1%; N = 11/18) than no‐CBT (7.7%; N = 1/13). Mixed models of binge‐eating frequency (assessed using complementary methods) converged revealing a significant interaction between CBT and time and a significant main effect of CBT. Binge‐eating frequency decreased significantly with CBT but did not change significantly with no‐CBT. Since only four patients received behavioral treatment during the acute treatments, we performed “sensitivity‐type” analyses restricted to the 27 patients who received pharmacotherapy during the acute treatment and found the same pattern of findings for CBT versus no‐CBT.ConclusionsAdult patients with BED who fail to respond to initial pharmacological treatments should be offered CBT.Public SignificanceEven with leading evidence‐based treatments for binge‐eating disorder, many patients do not derive sufficient benefit. Almost no controlled research has examined treatments for patients who fail to respond to initial interventions. This study found that that cognitive‐behavioral therapy was effective for patients with binge‐eating disorder who did not respond to initial interventions, with 61% achieving abstinence.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Overall No Cbt Cbt N = 31 N = 13 N = 18 Test Statistic P ...mentioning

confidence: 99%

Section: Overall No Cbt Cbt N = 31 N = 13 N = 18 Test Statistic P ...mentioning

confidence: 99%

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Cognitive‐behavioral therapy for binge‐eating disorder for non‐responders to initial acute treatments: Randomized controlled trial

Grilo

Lydecker

Gueorguieva

2023

Intl J Eating Disorders

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“…Further, BED is the most common eating disorder, impacting up to 3.5% of adults in their lifetime (Hudson, et al, 2007; Kessler et al, 2013; Smink et al, 2012; Udo & Grilo, 2018). At present, even the best interventions for BED demonstrate suboptimal outcomes (Grilo et al, 2021, 2022; Hilbert et al, 2019; Linardon, 2018), underscoring the need for improved models of binge-eating maintenance to help inform new or enhanced treatment approaches.…”

mentioning

confidence: 99%

Examining the role of craving in affect regulation models of binge eating: Evidence from an ecological momentary assessment study.

Schaefer¹,

Forester²,

Burr³

et al. 2023

Journal of Psychopathology and Clinical Science

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Affect regulation models hypothesize that aversive affective states drive binge-eating behavior, which serves to regulate unpleasant emotions. Research using ecological momentary assessment (EMA) demonstrates that increases in guilt most strongly predict subsequent binge-eating episodes, raising the question: why would individuals with binge-eating pathology engage in a binge-eating episode when they feel guilty? Food craving is a robust predictor of binge eating and is commonly associated with subsequent feelings of guilt. The current study used EMA to test the hypothesis that food craving may promote increased feelings of guilt, which then predict an increased risk of binge eating within a sample of 109 individuals with binge-eating disorder. Multilevel mediation models indicated that increased momentary craving at Time 1 directly predicted a greater likelihood of binge eating at Time 2, and craving also indirectly predicted binge eating at Time 2 through momentary increases in guilt at Time 2. In other words, experiencing food craving at one time point was related to an increased likelihood of binge eating at the next time point, and a portion of this influence was attributable to increasing feelings of guilt. These results challenge simple affect regulation models of binge eating, suggesting that food-related anticipatory reward processes (i.e., craving) may be the primary driver of binge-eating risk and account for the increases in guilt commonly observed prior to binge-eating episodes. Although experimental studies are needed to confirm this possibility, these results suggest the importance of addressing food cravings within interventions for binge-eating disorder.

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Improvements in cardiovascular disease risk factors associated with modest weight loss following treatment in patients with binge‐eating disorder and obesity

Yurkow,

Ivezaj,

Grilo

2023

Intl J Eating Disorders

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BackgroundModest weight losses may be associated with improvements in cardiovascular disease risk factors (CVDRF) in patients with obesity. The effects of weight losses on CVDRF in persons with binge‐eating disorder (BED) are unknown. This study prospectively examined changes in CVDRF among patients receiving behaviorally‐based weight‐loss treatment (BBWLT) who attained modest weight losses (≥5 to <10% and ≥10%).MethodOf 191 participants, CVDRF variables were re‐assessed in 168 participants at posttreatment and in 151 at 12‐month follow‐up. Participants who attained ≥5 to <10% weight loss were compared to those who did not on CVDRFs (total cholesterol, HDL, LDL, triglycerides, HbA1C, mean plasma glucose, heart rate, and systolic/diastolic blood pressure); similar comparisons were completed for those who attained ≥10% weight loss.ResultsAt posttreatment, ≥5 to <10% weight loss (N = 42; 25.0%) was associated with significant improvements in HbA1c and mean plasma glucose, whereas ≥10% weight loss (N = 40, 23.8%) was associated with significant improvements in total cholesterol, triglycerides, HbA1c, mean plasma glucose, and heart rate. At 12‐month follow‐up, ≥5 to <10% weight loss (N = 17; 11.1%) was related to significant improvements on HDL, triglycerides, HbA1c, and mean plasma glucose, whereas ≥10% weight loss (N = 40, 26.0%) was associated with significant improvements on all the CVDRF variables (except blood pressure).ConclusionsModest weight loss is associated with significant improvements in CVDRFs in patients with BED and obesity following treatment and at 12‐month follow‐up. Future work should examine whether improvements in CVDRF are attributable to weight loss per se and/or to other related lifestyle changes.Public significance statementIndividuals with binge‐eating disorder and obesity who attain modest weight loss following treatment exhibit improvements in various measures of cardiovascular disease risk compared to those who do not. While weight loss has been challenging for individuals with binge‐eating disorder, clinicians should inform patients of the potential health benefits of modest weight loss. Future research should investigate whether weight loss itself and/or related behavioral lifestyle changes drive improved cardiovascular disease risk factors.

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Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial

Cited by 41 publications

References 39 publications

Cognitive‐behavioral therapy for binge‐eating disorder for non‐responders to initial acute treatments: Randomized controlled trial

Cognitive‐behavioral therapy for binge‐eating disorder for non‐responders to initial acute treatments: Randomized controlled trial

Examining the role of craving in affect regulation models of binge eating: Evidence from an ecological momentary assessment study.

Improvements in cardiovascular disease risk factors associated with modest weight loss following treatment in patients with binge‐eating disorder and obesity

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