Men and women with bulimia and binge eating disorder are being sought for a clinical trial of a new drug combination that may treat the two eating disorders.
March 24, 2016 - By Erin Digitale
A team of researchers at the Stanford University School of Medicine is seeking adults with either bulimia nervosa or binge eating disorder to participate in a study that will assess whether a new combination of medications lessens symptoms of these illnesses.
“Bulimia and binge eating disorder have significant physical, psychological and social costs,” said principal investigator Debra Safer, MD, associate professor of psychiatry and behavioral sciences. “But there are now very few FDA-approved medications for these two eating disorders. And while psychotherapy can certainly help, it can be expensive and time-consuming. We need other treatment options to help these patients because even after completion of psychotherapy or medication treatment, up to 50 to 70 percent of patients still report continued symptoms.”
The study is enrolling 60 men and women ages 18 to 60 who have a body mass index of at least 21.0. Prospective participants must be available for check-ups at Stanford for the duration of the phase-1 study, which includes six months of treatment and two months of follow-up without medication. Participants must also have a medical provider or be willing to get one.
For 12 weeks, study participants will receive a combination of two drugs, topiramate and low-dose phentermine. This drug combination was approved by the U.S. Food and Drug Administration in 2012 for treatment of obesity, but has never been tested for bulimia or binge eating disorder. All participants in the clinical trial will also receive a placebo, or inactive treatment, for another 12 weeks.
Earlier studies have demonstrated that topiramate alone is effective at reducing symptoms of the two eating disorders, Safer noted. However, it causes some undesirable side effects, such as fatigue and cognitive dysfunction, that the low dose of phentermine is intended to counteract.
“These two eating disorders are difficult and complex, and our team believes it is important to find out if this medication combination can reduce binge eating and purging and thereby help patients achieve remission,” Safer said.
The research is funded by Stanford’s SPARK program, which enables partnerships between the university and industry to advance research discoveries. The medication being tested was donated for the research by the pharmaceutical company Vivus Inc. Participants will receive up to $100 for completing the study assessments.
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