Solriamfetol in Binge Eating Disorder

Exclusion Criteria

• •1. Have a current diagnosis of bulimia nervosa or anorexia nervosa.
• •2. Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered adequate methods of birth control: 1. intrauterine device (IUD); 2. barrier protection; 3. a contraceptive implantation system (Norplant); 4. oral contraceptive pills; 5. a surgically sterile patient; and 6. abstinence. All female participants will have a negative pregnancy test prior to randomization.
• •3. Individuals who are displaying clinically significant suicidality or homicidality.
• •4. Individuals who are receiving a psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED that was begun within the 3 months before study entry. Individuals beginning such treatment more than 3 months prior to study entry may be enrolled as long as they to agree to not make any changes to the frequency or nature of their treatment during the course of the drug trial.
• •5. A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
• •6. Individuals who have used psychostimulants to facilitate fasting or dieting as a part of their eating disorder within the past 6 months, individuals who have misused psychostimulants within the past 6 months, and individuals who have a drug screen at the Screening visit positive for psychostimulants.
• •7. Individuals with a lifetime DSM-IV-TR history of psychosis, mania or hypomania, or dementia.
• •8. Individuals with a history of any psychiatric disorder that might interfere with a diagnostic assessment, treatment, or study compliance.
• •9. Individuals who have a body mass index (BMI) ≤ 18 mg/kg2
• •10. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.
• •11. Have a history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problem.
• •12. History of seizures, including clinically febrile seizures in childhood.
• •13. Have uncontrolled hypertension (\>160/100) or tachycardia (heart rate \>110).
• •14. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator precludes study participation.
• •15. Have clinically relevant abnormal laboratory results, specifically including hypokalemia.
• •16. Have a history of narcolepsy or obstructive sleep apnea, or currently receiving treatment with an alerting agent.
• •17. Individuals requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes warfarin, anticonvulsants, clonidine, theophylline, and pseudoephedrine.
• •18. Individuals who have received any psychotropic medications (other than hypnotics) within four weeks prior to randomization, including antidepressants (including monoamine oxidase inhibitors), antipsychotics, mood stabilizers, or psychostimulants.
• •19. Individuals who have received investigational medications or depot neuroleptics within three months prior to randomization.
• •20. Individuals who have a known allergy to solriamfetol or its constituents.