The ENGAGE binge eating disorder study is looking for people who are*:
Ages 18-55 years old
Currently experiencing symptoms of binge eating disorder (BED) including recurrent episodes of consuming excessive amounts of food accompanied by a sense of loss of control over the eating
Experiencing at least 2 binge eating episodes per week for the past 6 months
*Additional criteria apply
Complete the online questionnaire here to see if you may qualify!
If you meet certain conditions and want to learn more, your information will be sent to a research center near you.
Study center staff will contact you to talk more about the study and get more information on your health history. You may be invited to the research center to take some tests.
At the research center, the study doctor will talk to you about your participation in the study. After you have asked all of your questions, you will be asked to sign a consent form.
Click the button below to fill out a brief 7 question form to see if you may be eligible for the ENGAGE study.
By filling out this form, you are under no obligation to participate in the study. Your information will be forwarded to the study site closest to you where a member of the staff will reach out via phone, email, or text to collect more information.
Click to take a brief 7-question self-assessment to determine study eligibilityComplete the online questionnaire here to see if you may qualify!
If you meet certain conditions and want to learn more, your information will be sent to a research center near you.
Study center staff will contact you to talk more about the study and get more information on your health history. You may be invited to the research center to take some tests.
At the research center, the study doctor will talk to you about your participation in the study. After you have asked all of your questions, you will be asked to sign a consent form.
Click the button below to fill out a brief 7 question form to see if you may be eligible for the ENGAGE study.
By filling out this form, you are under no obligation to participate in the study. Your information will be forwarded to the study site closest to you where a member of the staff will reach out via phone, email, or text to collect more information.
Click to take a brief 7-question self-assessment to determine study eligibility
The ENGAGE study is a clinical research study currently being conducted at select centers in the US, evaluating the safety
and efficacy of an investigational oral medication (solriamfetol) in adults with binge eating disorder.
Solriamfetol is approved by the U.S. Food and Drug Administration (FDA) for people who have excessive daytime sleepiness
associated with narcolepsy or obstructive sleep apnea (OSA), which are sleep related disorders. Solriamfetol is an investigational
treatment for BED, meaning it has not yet been approved by any health authority for the treatment of BED.
If the study doctor and staff determine you are eligible and you choose to participate in the ENGAGE study, you may be in the study for up to 18 weeks. There are 10 in-person visits at the study site you choose and 2 remote visits by phone. As a participant in the study, it is important to understand how many visits you need to attend when you make the decision to participate.
Screening Period
(up to 5 weeks)
This is the time when the study doctor and staff determine if you are eligible for the study. You will come in for your first visit and will answer some questions and do some medical tests to see if you may be a good fit for the study.
Study Treatment Period
(12 weeks)
If you are eligible for the study, you will then enter the study treatment period which lasts for up to 12 weeks and involves 9 clinic visits and 1 remote visit. You will be randomly assigned to take either solriamfetol or placebo*.
Follow-Up Period
(1 week)
At the end of the study treatment period, you may be given the option to enter an open-label study, where all participants receive solriamfetol.
If you choose to not enter the open-label study, you will be contacted via phone by the site 1 week after your final in-clinic visit to check in and see how you are doing.
Screening Period
(up to 5 weeks)
This is the time when the study doctor and staff determine if you are eligible for the study. You will come in for your first visit and will answer some questions and do some medical tests to see if you may be a good fit for the study.
Study Treatment Period
(12 weeks)
If you are eligible for the study, you will then enter the study treatment period which lasts for up to 12 weeks and involves 9 clinic visits and 1 remote visit. You will be randomly assigned to take either solriamfetol or placebo*.
Follow Up Period
(1 week)
At the end of the study treatment period, you may be given the option to enter an open-label study, where all participants receive solriamfetol.
If you choose to not enter the open-label study, you will be contacted via phone by the site 1 week after your final in-clinic visit to check in and see how you are doing.
*A placebo is a capsule that looks like the investigational medication but does not contain any active ingredients. It is used to compare the effectiveness of the investigational medication. Neither you nor the study doctor will know which you are taking in order for the results of the study to be fair.
If you're living with binge eating disorder, the ENGAGE study may be right for you. If you are eligible to participate:
You may receive study-related care and study evaluations at no cost.
You may also receive compensation for your time and travel.
You may have the opportunity to help advance potential new treatments for people with binge eating disorder*.
*Solriamfetol is an investigational oral medication being studied for binge eating disorder.
Binge Eating Disorder (BED) is characterized by recurrent episodes of binge eating.
A binge eating episode consists of consuming an excessive amount of food within a discrete period of time (e.g., within any 2-hour
period) accompanied by a sense of lack of control over the eating during the episode (e.g., a feeling that one cannot stop eating
or control what or how much one is eating).
In binge eating disorder, the binge eating is not associated with regular use of weight-compensatory behaviors (like making oneself
sick, fasting, or excessive exercise).
Living with binge eating disorder can be difficult. If you've been experiencing any of the following behaviors or symptoms, you may be experiencing symptoms of BED:
Eating a large amount of food in a short amount of time; for example, within 2 hours 1
Feeling a lack of control over one's eating; for example, someone who cannot stop eating or control what or how much they are eating
Feelings of guilt, disgust, depression, or worthlessness after overeating1
Eating alone because of embarrassment about the amount of food one may eat
Eating more quickly than usual during binge episodes
Eating until feeling uncomfortably full
Eating large amounts of food even when not hungry
Click here to see if you may be eligible for the ENGAGE study.
[1] American Psychiatric Association. DSM-5-Eating Disorders. Updated 2013. Accessed January 26, 2021.
www.psychiatry.org/
psychiatrists/practice/dsm
