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Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

NCT ID: NCT02317744

Last Updated: 2017-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Binge Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Naltrexone/ Bupropion combination

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

Group Type EXPERIMENTAL

Naltrexone and bupropion combination

Intervention Type DRUG

Pill placebo

Daily placebo medication for 3 months

Group Type PLACEBO_COMPARATOR

Pill Placebo

Intervention Type OTHER

Interventions

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Naltrexone and bupropion combination

Intervention Type DRUG

Pill Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos M Grilo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33218742 (View on PubMed)

Other Identifiers

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1409014705

Identifier Type: -

Identifier Source: org_study_id