RECRUITING

Solriamfetol in Binge Eating Disorder

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Solriamfetol in Binge Eating Disorder

Quick Facts

Study Start:2021-06-15

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04602936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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.

Inclusion Criteria

Exclusion Criteria

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.

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.

Contacts and Locations

Study Contact

Anna Guerdjikova

CONTACT

513-536-0700

anna.guerdjikova@lindnercenter.org

Genie Groff

CONTACT

513-536-0700

genie.groff@lindnercenter.org

Study Locations (Sites)

Lindner Center of HOPE

Mason, Ohio, 45040

United States

Collaborators and Investigators

Sponsor: Lindner Center of HOPE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-15

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2021-06-15

Study Completion Date2024-12-30

Terms related to this study

Additional Relevant MeSH Terms

Binge Eating Disorder