Overview

Solriamfetol in Binge Eating Disorder

Status:
Not yet recruiting
Trial end date:
2023-03-30
Target enrollment:
0
Participant gender:
All
Summary
The goal of this project is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the treatment of binge eating disorder (BED).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lindner Center of HOPE
Collaborator:
Jazz Pharmaceuticals
Criteria
Inclusion Criteria: Criteria for entering this study will include all of the following:

1. Participants will meet DSM-5 criteria for a diagnosis of BED. These criteria are:

1. Recurrent episodes of binge eating. Both of the following characterize a
binge-eating episode: 1. Eating, in a discrete period (e.g., within 2 hours), an
amount of food that is definitely larger than most people would eat in a similar
period under similar conditions; and 2. A sense of lack of control over the
eating (e.g., a feeling that one cannot stop eating or control what or how much
one is eating).

2. The binge-eating episodes are associated with at least three of the following:
eating much more rapidly than normal; eating until uncomfortably full; eating
large amounts of food when not feeling physically hungry; eating alone because of
being embarrassed by how much one is eating; feeling disgusted with oneself,
depressed, or feeling very guilty after overeating.

3. Marked distress regarding binge eating.

4. The binge eating occurs, on average, at least one day a week for 3 months.

5. The episodes of binge eating do not occur exclusively during the course of
bulimia nervosa or anorexia nervosa.

2. In addition, to ensure that BED is of at least moderate severity, participants will
report at least three binge-eating days per week during the 1 week prior to initiation
of study medication, prospectively documented in take-home binge diaries. A
binge-eating day (or binge day) is a day during which at least one binge-eating
episode occurs.

3. Men or women, through the ages of 18 and 65 years, inclusive.

Exclusion Criteria: Criteria for exclusion from this study will be any of the following:

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.