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NB Medication (on-going from acute treatment) for Obesity

Phase 2 & 3
Waitlist Available
Led By Carlos M Grilo, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participated in acute treatment for binge-eating disorder and obesity;
Did not have a positive response to acute treatment;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month follow-up
Awards & highlights

Study Summary

This trial will test whether cognitive-behavioral therapy, when added to existing pharmacotherapy, helps people with binge eating disorder who are also obese.

Eligible Conditions
  • Obesity
  • Binge Eating Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Mass Index at 4 Months Post-Treatment From Baseline
Secondary outcome measures
Binge Eating Frequency (Continuous)
Other outcome measures
Body Mass Index

Side effects data

From 2022 Phase 2 & 3 trial • 31 Patients • NCT03063606
13%
Diarrhea
7%
Insomnia
7%
Constipation
7%
Nausea
7%
Vomiting
7%
Dry Mouth
7%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
On-going Blinded Pharmacotherapy (NB)
On-going Blinded Pharmacotherapy (Placebo)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive-Behavioral Therapy (CBT)Experimental Treatment2 Interventions
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.
Group II: Naltrexone/bupropion (NB) (on-going from acute stage)Active Control1 Intervention
Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive-Behavioral Therapy (CBT)
2014
Completed Phase 3
~870
NB Medication (on-going from acute treatment)
2017
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,314,168 Total Patients Enrolled
440 Trials studying Obesity
588,084 Patients Enrolled for Obesity
Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,382 Total Patients Enrolled
59 Trials studying Obesity
248,117 Patients Enrolled for Obesity
Carlos M Grilo, PhDPrincipal InvestigatorYale School of Medicine
4 Previous Clinical Trials
427 Total Patients Enrolled
3 Trials studying Obesity
338 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a potential test subject is middle-aged, will they still be able to participate in this research?

"This trial is only open to adults aged 18-70. Out of the 963 active clinical trials, 252 are for patients under 18 and 718 are for people 65 and older."

Answered by AI

What does NB Medication help patients with when they take it over an extended period of time?

"NB Medication (on-going from acute treatment) is not only useful in treating ADHD, but also seasonal affective disorder, smoking cessation, and smoke."

Answered by AI

How can I participate in this research trial?

"Up to 38 individuals between 18 and 70 years old may be enrolled in this trial if they currently suffer from binge-eating disorder. Furthermore, it is imperative that potential patients also meet the following conditions: a recent history of treatment for both binge-eating disorder and obesity with no positive response, being available for the next 20 months, travelling ability to New Haven, Connecticut for weekly visits."

Answered by AI

Are patients needed for this experiment currently?

"Although this particular trial is not looking for more participants, the clinicaltrial.gov website indicates that it was last updated on 7/27/2022 and was initially posted on 9/5/2017. There are 1161 other trials that are actively recruiting right now if you're interested in participating in medical research."

Answered by AI
~4 spots leftby Mar 2025