NCT02317744

Brief Summary

This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

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

December 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 22, 2017

Completed
Last Updated

December 22, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

December 11, 2014

Results QC Date

October 13, 2017

Last Update Submit

November 21, 2017

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (2)

  • Binge Eating Frequency (Continuous)

    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).

    Post-treatment (at 3 months)

  • Binge Eating Frequency (Continuous)

    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).

    6 month follow-up (an average of 6 months following treatment)

Secondary Outcomes (2)

  • Body Mass Index (BMI)

    Post-treatment (at 3 months)

  • Body Mass Index (BMI)

    6 month follow-up (an average of 6 months following treatment)

Study Arms (2)

Naltrexone/ Bupropion combination

EXPERIMENTAL

50 mg naltrexone and 300 mg bupropion per day for 3 months

Drug: Naltrexone and bupropion combination

Pill placebo

PLACEBO COMPARATOR

Daily placebo medication for 3 months

Other: Pill Placebo

Interventions

Naltrexone and bupropion combinationDRUG
Naltrexone/ Bupropion combination
Pill PlaceboOTHER
Pill placebo

Eligibility Criteria

Age21 Years - 65 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 between 30 kg/m2 and 50 kg/m2
  • Not taking anti-depressant medications
  • Read English proficiently enough to read study assessments
  • Available for duration of treatment plus follow-up period
  • Able to travel to study location (New Haven, CT) for monthly visits
  • Agree to study procedures

You may not qualify if:

  • Medical status judged by study physician as contraindication
  • History of seizures
  • Past or current anorexia nervosa, bulimia nervosa
  • Current medications that influence eating/weight
  • Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18.

    PMID: 33218742DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Naltrexone-Bupropion combination

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Results Point of Contact

Title
Dr. Carlos Grilo
Organization
Yale School of Medicine
carlos.grilo@yale.edu
203-785-2792

Study Officials

  • Carlos M Grilo, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
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

December 11, 2014

First Posted

December 16, 2014

Study Start

December 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 22, 2017

Results First Posted

December 22, 2017

Record last verified: 2017-11

Locations

US(1)