Condition or disease | Intervention/treatment | Phase |
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Binge-Eating Disorder Obesity | Drug: Naltrexone and Bupropion Other: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity |
Actual Study Start Date : | August 7, 2019 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
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Experimental: Naltrexone/Bupropion |
Drug: Naltrexone and Bupropion
Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.
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Placebo Comparator: Placebo |
Other: Placebo
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Valentina Ivezaj, Ph.D. | 203-785-7210 | valentina.ivezaj@yale.edu |
United States, Connecticut | |
Yale Department of Psychiatry | Recruiting |
New Haven, Connecticut, United States, 06510 | |
Contact: Valentina Ivezaj, Ph.D. 203-785-7210 valentina.ivezaj@yale.edu | |
Principal Investigator: Carlos M Grilo, Ph.D. |
Principal Investigator: | Carlos M Grilo, Ph.D. | Yale School of Medicine |
Tracking Information | |||||
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First Submitted Date ICMJE | April 22, 2019 | ||||
First Posted Date ICMJE | May 10, 2019 | ||||
Last Update Posted Date | January 14, 2021 | ||||
Actual Study Start Date ICMJE | August 7, 2019 | ||||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders | ||||
Official Title ICMJE | Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity | ||||
Brief Summary | This study will test the relative efficacy and effectiveness of the combination of naltrexone and bupropion (NB) medication as a treatment for binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, NB medication results in superior outcomes compared with placebo. | ||||
Detailed Description | Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether Naltrexone/Bupropion medication results in superior and longer-term outcomes than placebo. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 2024 | ||||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 64 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03946111 | ||||
Other Study ID Numbers ICMJE | 2000022480_a | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Yale University | ||||
Study Sponsor ICMJE | Yale University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Yale University | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |