Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment

NCT03063606 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 1506016065-SR01DK049587
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .

Conditions

Binge-Eating Disorder; Obesity

Outcome Measures

Primary Outcomes (2)

• Binge Eating Frequency (Continuous)

  Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.

  Post-treatment (4 months)

• Change in Body Mass Index at 4 Months Post-Treatment From Baseline

  BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline

  Baseline and Post-treatment (4 months)

Secondary Outcomes (2)

• Binge Eating Frequency (Continuous)

  6-Month Follow-up

• Binge Eating Frequency (Continuous)

  12-Month Follow-up

Other Outcomes (2)

• Body Mass Index

  12-Month Follow-up

• Body Mass Index

  6-Month Follow-up

Study Arms (2)

Cognitive-Behavioral Therapy (CBT)

EXPERIMENTAL

CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.

Behavioral: Cognitive-Behavioral Therapy (CBT); Drug: NB Medication (on-going from acute treatment)

Naltrexone/bupropion (NB) (on-going from acute stage)

ACTIVE COMPARATOR

Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.

Drug: NB Medication (on-going from acute treatment)

Interventions

Cognitive-Behavioral Therapy (CBT) BEHAVIORAL

CBT specialist treatment

Cognitive-Behavioral Therapy (CBT)

NB Medication (on-going from acute treatment) DRUG

Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)

Also known as: Contrave

Cognitive-Behavioral Therapy (CBT); Naltrexone/bupropion (NB) (on-going from acute stage)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participated in acute treatment for binge-eating disorder and obesity;
• Did not have a positive response to acute treatment;
• Available for the duration of the treatment and follow-up (20 months);
• Read, comprehend, and write English at a sufficient level to complete study-related materials; and
• Able to travel to study location (New Haven, CT) for weekly visits.

You may not qualify if:

• Currently taking anti-depressant medications;
• Currently taking opioid pain medications or drugs;
• Currently taking medications that influence eating/weight;
• History of seizures;
• Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
• Past or current anorexia nervosa, bulimia nervosa;
• Pregnant or breastfeeding;
• Medical status judged by study physician as contraindication.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity

Interventions

Cognitive Behavioral Therapy; bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Carlos Grilo
• Organization: Yale University

carlos.grilo@yale.edu

203-785-7210

Study Officials

• Carlos M Grilo, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 24, 2017
• Study Start: September 5, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 16, 2022
• Last Updated: February 1, 2024
• Results First Posted: July 7, 2023

Record last verified: 2024-01

Locations

US (1)