Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment
NCT ID: NCT03063606
Last Updated: 2024-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
31 participants
INTERVENTIONAL
2017-09-05
2022-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Cognitive-Behavioral Therapy (CBT)
CBT specialist treatment
NB Medication (on-going from acute treatment)
Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
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.
NB Medication (on-going from acute treatment)
Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Interventions
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Cognitive-Behavioral Therapy (CBT)
CBT specialist treatment
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Carlos M Grilo, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1506016065-S
Identifier Type: -
Identifier Source: org_study_id
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