Solriamfetol for Binge Eating Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness and tolerability of solriamfetol for treating binge eating disorder (BED). Solriamfetol affects brain chemicals to help control urges to binge eat. Participants will receive either solriamfetol or a placebo (an inactive pill) to compare outcomes. Individuals who have experienced frequent binge eating episodes, at least three times a week for the past week, might be a good fit for this trial.
As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop taking any psychotropic medications (medications affecting mood, perception, or behavior) at least four weeks before starting the study. This includes antidepressants, antipsychotics, mood stabilizers, and psychostimulants. If you are on any medications that might interact with the study drug, like warfarin or anticonvulsants, you may also need to stop those.
What is the safety track record for solriamfetol?
Research has shown that solriamfetol is generally safe and well-tolerated in people. In previous studies, the observed side effects were expected and manageable. Solriamfetol has already received approval for other uses, providing some reassurance about its safety. While no treatment is without risk, current evidence suggests that solriamfetol is a relatively safe option for those considering joining a clinical trial for binge eating disorder.12345
Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for binge eating disorder, which typically include options like cognitive behavioral therapy and medications such as selective serotonin reuptake inhibitors (SSRIs), solriamfetol offers a novel approach by acting as a dopamine and norepinephrine reuptake inhibitor. This unique mechanism of action potentially enhances focus and energy levels, which could help reduce binge-eating episodes. Researchers are excited about solriamfetol because it might provide quicker behavioral improvements compared to other medications, offering a promising alternative for those who don't respond well to existing treatments.
What evidence suggests that solriamfetol might be an effective treatment for binge eating disorder?
This trial will evaluate the effectiveness of solriamfetol for binge eating disorder (BED). Research has shown that solriamfetol, a type of medication, is effective for certain conditions. It is approved for treating excessive daytime sleepiness in people with narcolepsy and sleep apnea. Although direct evidence for its use in BED is limited, its mechanism suggests it might help reduce binge eating episodes. Solriamfetol increases levels of certain brain chemicals, dopamine and norepinephrine, which can influence mood and impulse control. Early signs are promising, but more research is needed to confirm its effectiveness for BED specifically. Participants in this trial will receive either solriamfetol or a placebo to assess its potential benefits for BED.13456
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with Binge Eating Disorder (BED), experiencing significant distress and at least three binge-eating days per week. They must meet DSM-5 criteria for BED without a history of bulimia or anorexia nervosa. Excluded are pregnant individuals, those with recent substance abuse, serious psychiatric or medical conditions, uncontrolled hypertension or heart issues, misuse of stimulants, and anyone on certain medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive solriamfetol or placebo for 12 weeks, with weekly evaluations for the first 4 weeks and biweekly evaluations for the next 8 weeks
Treatment Discontinuation
Participants discontinue treatment and are monitored for any withdrawal effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Solriamfetol
Solriamfetol is already approved in United States for the following indications:
- Excessive daytime sleepiness in patients with narcolepsy
- Excessive daytime sleepiness in patients with obstructive sleep apnea
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lindner Center of HOPE
Lead Sponsor
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland