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

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ClinicalTrials.gov Identifier: NCT03063606
Recruitment Status : Enrolling by invitation
First Posted : February 24, 2017
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

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 .

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Obesity Behavioral: Cognitive-Behavioral Therapy (CBT) Drug: NB Medication (on-going from acute treatment) Phase 2 Phase 3

Detailed Description:
Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive-Behavioral Therapy (CBT)
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)
CBT specialist treatment

Drug: NB Medication (on-going from acute treatment)
Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Other Name: Contrave

Active Comparator: Naltrexone/bupropion (NB) (on-going from acute stage)
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)
Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Other Name: Contrave




Primary Outcome Measures :
  1. Binge Eating Frequency (Continuous) [ Time Frame: Post-treatment (4 months) ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

  2. Body Mass Index [ Time Frame: Post-treatment (4 months) ]
    BMI is calculated using measured height and weight (e.g., percent loss).


Secondary Outcome Measures :
  1. Binge Eating Frequency (Continuous) [ Time Frame: 6-Month Follow-up ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

  2. Binge Eating Frequency (Continuous) [ Time Frame: 12-Month Follow-up ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

  3. Body Mass Index [ Time Frame: 6-Month Follow-up ]
    BMI is calculated using measured height and weight (e.g., percent loss).

  4. Body Mass Index [ Time Frame: 12-Month Follow-up ]
    BMI is calculated using measured height and weight (e.g., percent loss).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063606


Locations
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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Carlos M Grilo, PhD Yale School of Medicine

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03063606     History of Changes
Other Study ID Numbers: 1506016065-S
R01DK049587 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Nutrition Disorders
Mental Disorders
Hyperphagia
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Naltrexone
Bupropion
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors