NCT03539900

Brief Summary

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 24, 2023

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

May 16, 2018

Results QC Date

April 17, 2023

Last Update Submit

March 11, 2024

Conditions

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (2)

  • Change in Binge Eating Frequency

    Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."

    Post-treatment (3 months)

  • Percent BMI Change

    BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss.

    Post-treatment (3 months)

Secondary Outcomes (4)

  • Change in Binge Eating Frequency

    6 months post-treatment

  • Change in Binge Eating Frequency

    12 months post-treatment

  • Body Mass Index

    6 months post-treatment

  • Body Mass Index

    12 months post-treatment

Study Arms (2)

NB Medication

EXPERIMENTAL

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Placebo

PLACEBO COMPARATOR

Placebo will be inactive and taken daily in pill form.

Other: Placebo

Interventions

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug CombinationDRUG

NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.

Also known as: Contrave
NB Medication
PlaceboOTHER

Placebo will be inactive and taken daily in pill form.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
  • BMI in the obesity (BMI \>30 and \<50) or non-obesity (BMI \>21.5 and \<29.9) range;
  • Available for the duration of the treatment and follow-up (15 months);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials.

You may not qualify if:

  • Currently taking opioid pain medications or drugs; or positive drug screen for opiates
  • 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 or bulimia nervosa;
  • Pregnant or breastfeeding;
  • Medical status judged by study physician as contraindication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

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

  • Sherry McKee, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 29, 2018

Study Start

April 17, 2018

Primary Completion

April 19, 2022

Study Completion

March 22, 2023

Last Updated

April 3, 2024

Results First Posted

July 24, 2023

Record last verified: 2024-03

Locations

US(1)