Anorexia Nervosa/BulimiaPhase 2/3ONPEDNCT05073679
Oral Naltrexone In Pediatric Eating Disorders
A Phase 2/3 study testing Naltrexone Hydrochloride in people with Anorexia Nervosa/Bulimia and Anorexia in Adolescence, run by Rosemary Claire Roden at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Anorexia Nervosa/Bulimia, Anorexia in Adolescence, Anorexia Nervosa, Atypical
- What is being tested?
- Naltrexone Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 21 May 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 13-25 (inclusive)
- Any sex
- Diagnoses of anorexia nervosa binge-purge subtype, bulimia nervosa, purging disorder, or atypical anorexia nervosa with bingeing or purging behaviors according to the Diagnostic and Statistical Manual version 5 diagnostic criteria
- Electing to participate in child or adult partial hospitalization program for eating disorder treatment at MSHMC
- The diagnostic criteria for anorexia nervosa, binge-purge subtype, are:
- Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than minimally expected.
Show all 16Show fewer
- Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight.
- Disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight D. During the last three months the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting, or the misuse of laxatives, diuretics, or enemas).19 E. A diagnosis of atypical anorexia nervosa can be made when the body weight is normal or high If these patients engage in bingeing or purging behaviors as defined in anorexia nervosa, binge-purge subtype, they are eligible for inclusion in this study
- The diagnostic criteria for bulimia nervosa are:
- Recurrent episodes of binge eating. An episode of binge eating is characterized by
- both:
- Eating in a discrete period of time (e.g. within any 2 hour period), an amount of food that is definitely larger than what most individuals would eat in a similar period of time under similar circumstances; ii. A sense of lack of control over eating during the episodes (e.g. a feeling that one cannot stop eating or control what or how much one is eating.
- Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise.
- The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months.
- Self-evaluation is unduly influenced by body shape and weight. F. The disturbance does not occur exclusively during episodes of anorexia nervosa.
- The diagnostic criteria for purging disorder are: recurrent purging behavior to influence weight or shape (e.g. self-induced vomiting; misuse of laxatives, diuretics, or other medications) in the absence of binge eating.
Who cannot join
- Diagnosis of intellectual disability
- History of known genetic or neurologic disease
- Need for treatment with opioid painkillers
- Weight <25kg
- Inability to swallow pills
- Lack of proficiency in written or spoken English
Show all 10Show fewer
- Urine drug screen positive for opioids at enrollment
- Positive serum pregnancy test at enrollment
- Lactation
- Elevation of three times the upper limit of normal for age in either alanine aminotransferase (ALT) or asparagine aminotransferase (AST).High risk of suicide at enrollment on Columbia Suicide Severity Rating Scale (C-SSRS, for participants age 18-25) or Ask Suicide Screening Questions (ASQ, participants age 13 to 17)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder.
Read the detailed description
Subjects participating in this study will receive routine care for eating disorder at a partial hospitalization (PHP) level of care at MSHMC. In PHP, all patients have weekly medical screening visits for the duration of their time in care, as well as weekly individual therapy sessions, individual dietician sessions, and psychiatry appointments. They have supervised meals and numerous group therapy sessions. Every three weeks, patients in PHP complete a battery of mood and eating disorder indices including those evaluated in this study; participants in this study will complete an additional two surveys with this routine battery. Participants in this study will have no alterations in their routine eating disorder care outside of study article use and these additional surveys.
Subjects will be enrolled at their first visit for eating disorder programming at child or adult partial hospitalization (PHP) programming at MSHMC adolescent medicine eating disorders clinic. Informed consent/assent will be obtained as described above.
The subject will be provided with oral naltrexone or placebo weekly from the MSHMC research pharmacy. Subjects will be given one weeks' worth of medication at a time. Subjects will be randomized at enrollment to receive either study drug (naltrexone) or placebo. Participants or parents of minor participants will be provided study drug or placebo following completion of urine drug screen and consent/assent. Patients will take the medication daily for six weeks. For subjects who are enrolled in child PHP and who eat meals with parents, the families may choose to administer study drug during meals at programming. For adult patients enrolled in adult programming, subjects may choose to self-administer the medication.
On their first contact with PHP, all patients in Child PHP complete various eating disorder indices as a part of routine care, including the ED-15, EDE-Q, RCMAS, CDI, GAD-7, and PHQ-9. This battery of indices is repeated every 3 weeks while a patient is in programming.
For those who are enrolled in this study, they will complete their routine indices, in addition they will also complete the BIS/BAS and the ABUSI at enrollment and at weeks 3, 6, and 9 (after completion of medication) while in programming. Participants will receive routine eating disorder care while in PHP.
Patients in Adult PHP typically complete a different inventory every three weeks. If a patient chooses to participate in this study they will be asked to complete the same surveys as participants in Child PHP, and they will receive the same amount and type of compensation.
Six months after enrollment, subjects will be sent copies of ED-15, EDE-Q, GAD-7, PHQ-9, BIS/BAS, and ABUSI indices either in an in-person medical appointment or via RedCap to complete. If the patient returns for medical follow-up between 5 and 7 months after enrollment, their height, weight, and body mass index will also be recorded to determine if weight restoration was maintained.
At initial contact with the eating disorders clinic, all patients receive an initial battery of laboratory tests as a part of the standard of care for eating disorder. These tests include liver function assays and transaminase levels.
- Conditions
- Anorexia Nervosa/Bulimia, Anorexia in Adolescence, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Purging (Eating Disorders), Impulsive Behavior
- Being tested
- Naltrexone Hydrochloride, Control
- Medical subject headings
- Anorexia Nervosa, Bulimia, Feeding and Eating Disorders, Impulsive Behavior, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HydrochlorideDrug
25mg x 3 days then 50mg a day thereafter
ControlOther
Methylcellulose and gelatin capsule only
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Receives: Drug: Naltrexone Hydrochloride |
| Control | Placebo comparator | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Measured: Time Frame: Measured at the following timepoints: enrollment
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Measured: Time Frame: Measured at the following timepoints: one week
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Measured: Time Frame: Measured at the following timepoints: three week
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Measured: Time Frame: Measured at the following timepoints: six weeks
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Measured: Time Frame: Measured at the following timepoints: nine weeks (last week of treatment)
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Measured: Time Frame: Measured at the following timepoints: 6 months after enrollment
Secondary outcomes (34)
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Measured: Measured at the following timepoints: enrollment
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Measured: Measured at the following timepoints: one week
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Measured: Measured at the following timepoints: three weeks
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Measured: Measured at the following timepoints: six weeks
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Measured: Measured at the following timepoints: nine weeks (last week of treatment)
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Measured: Measured at the following timepoints: 6 months after enrollment
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Measured: Measured at the following timepoints: enrollment
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Measured: Measured at the following timepoints: one week
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Measured: Measured at the following timepoints: three weeks
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Measured: Measured at the following timepoints: six weeks
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Measured: Measured at the following timepoints: nine weeks (last week of treatment)
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Measured: Measured at the following timepoints: 6 months after enrollment
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Measured: Measured at the following timepoints: enrollment
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Measured: Measured at the following timepoints: one week
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Measured: Measured at the following timepoints: three weeks
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Measured: Measured at the following timepoints: six weeks
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Measured: Measured at the following timepoints: nine weeks (last week of treatment)
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Measured: Measured at the following timepoints: 6 months after enrollment
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Measured: Measured at the following timepoints: enrollment
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Measured: Measured at the following timepoints: one week
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Measured: Measured at the following timepoints: three weeks
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Measured: Measured at the following timepoints: six weeks
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Measured: Measured at the following timepoints: nine weeks (last week of treatment)
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Measured: Measured at the following timepoints: 6 months after enrollment
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Measured: Measured at the following timepoints: enrollment
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Measured: Measured at the following timepoints: one week
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Measured: Measured at the following timepoints: three weeks
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Measured: Measured at the following timepoints: six weeks
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Measured: Measured at the following timepoints: nine weeks (last week of treatment)
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Measured: Measured at the following timepoints: 6 months after enrollment
Percent of Weight Restoration
For participants who need to restore weight, will evaluate the percent of weight gain in care
Measured: Will evaluate total percent of weight restoration via chart review at 9 weeks
Percent of Weight Restoration
For participants who need to restore weight, will evaluate the percent of weight gain in care
Measured: Will evaluate total percent of weight restoration via chart review 6 months after enrollment at about 33 weeks
Need For Higher Level of Care
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
Measured: Will evaluate need for higher level of care at nine weeks
Need For Higher Level of Care
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
Measured: Will evaluate need for higher level of care at 6 months after the end of the study at about 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start22 Apr 2022
- Primary completion21 May 2024
- Study completion21 May 2024
Why it stopped: Low enrollment numbers, pharmacy not able to acquire sufficient study article component (methylcellulose) due to manufacturer backorder
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anorexia Nervosa/BulimiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, placebo controlled randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosemary Claire Roden
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Sponsor-investigator, Rosemary Claire Roden, Milton S. Hershey Medical Center
- Investigators
- Rosemary C Roden, MD, Principal investigator, PennState Health Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073679
- Sponsor's protocol ID
- STUDY00014382
- Other IDs
- 150408
- Acronym
- ONPED
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2021
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data is planned to be shared at the moment to protect patient privacy, as participants are all enrolled in a partial hospitalization program for mental health conditions.
Publications
Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: The ED-15. Int J Eat Disord. 2015 Nov;48(7):1005-15. doi: 10.1002/eat.22430. Epub 2015 May 26.
PubMed 26011054Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
PubMed 7866415Smucker MR, Craighead WE, Craighead LW, Green BJ. Normative and reliability data for the Children's Depression Inventory. J Abnorm Child Psychol. 1986 Mar;14(1):25-39. doi: 10.1007/BF00917219.
PubMed 3950219Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276.
PubMed 23027429Campbell K, Peebles R. Eating disorders in children and adolescents: state of the art review. Pediatrics. 2014 Sep;134(3):582-92. doi: 10.1542/peds.2014-0194.
PubMed 25157017Roden RC, Billman M, Lane-Loney S, Essayli J, Mahr F, Vrana K, Ryan S. An experimental protocol for a double-blind placebo-controlled evaluation of the effectiveness of oral naltrexone in management of adolescent eating disorders. Contemp Clin Trials. 2022 Nov;122:106937. doi: 10.1016/j.cct.2022.106937. Epub 2022 Sep 24.
PubMed 36167287
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders
- ClinicalTrials.gov ID
- NCT05073679
- Acronym / sponsor ID
- ONPED / STUDY00014382
- Conditions
- Anorexia Nervosa/Bulimia, Anorexia in Adolescence, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Purging (Eating Disorders), Impulsive Behavior
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment numbers, pharmacy not able to acquire sufficient study article component (methylcellulose) due to manufacturer backorder
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rosemary Claire RodenUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder.
Detailed description
Subjects participating in this study will receive routine care for eating disorder at a partial hospitalization (PHP) level of care at MSHMC. In PHP, all patients have weekly medical screening visits for the duration of their time in care, as well as weekly individual therapy sessions, individual dietician sessions, and psychiatry appointments. They have supervised meals and numerous group therapy sessions. Every three weeks, patients in PHP complete a battery of mood and eating disorder indices including those evaluated in this study; participants in this study will complete an additional two surveys with this routine battery. Participants in this study will have no alterations in their routine eating disorder care outside of study article use and these additional surveys.
Subjects will be enrolled at their first visit for eating disorder programming at child or adult partial hospitalization (PHP) programming at MSHMC adolescent medicine eating disorders clinic. Informed consent/assent will be obtained as described above.
The subject will be provided with oral naltrexone or placebo weekly from the MSHMC research pharmacy. Subjects will be given one weeks' worth of medication at a time. Subjects will be randomized at enrollment to receive either study drug (naltrexone) or placebo. Participants or parents of minor participants will be provided study drug or placebo following completion of urine drug screen and consent/assent. Patients will take the medication daily for six weeks. For subjects who are enrolled in child PHP and who eat meals with parents, the families may choose to administer study drug during meals at programming. For adult patients enrolled in adult programming, subjects may choose to self-administer the medication.
On their first contact with PHP, all patients in Child PHP complete various eating disorder indices as a part of routine care, including the ED-15, EDE-Q, RCMAS, CDI, GAD-7, and PHQ-9. This battery of indices is repeated every 3 weeks while a patient is in programming.
For those who are enrolled in this study, they will complete their routine indices, in addition they will also complete the BIS/BAS and the ABUSI at enrollment and at weeks 3, 6, and 9 (after completion of medication) while in programming. Participants will receive routine eating disorder care while in PHP.
Patients in Adult PHP typically complete a different inventory every three weeks. If a patient chooses to participate in this study they will be asked to complete the same surveys as participants in Child PHP, and they will receive the same amount and type of compensation.
Six months after enrollment, subjects will be sent copies of ED-15, EDE-Q, GAD-7, PHQ-9, BIS/BAS, and ABUSI indices either in an in-person medical appointment or via RedCap to complete. If the patient returns for medical follow-up between 5 and 7 months after enrollment, their height, weight, and body mass index will also be recorded to determine if weight restoration was maintained.
At initial contact with the eating disorders clinic, all patients receive an initial battery of laboratory tests as a part of the standard of care for eating disorder. These tests include liver function assays and transaminase levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blind, placebo controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Naltrexone HydrochlorideOral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler |
| Control | Placebo comparator | Other: ControlOpaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Ages 13-25 (inclusive)
- Any sex
- Diagnoses of anorexia nervosa binge-purge subtype, bulimia nervosa, purging disorder, or atypical anorexia nervosa with bingeing or purging behaviors according to the Diagnostic and Statistical Manual version 5 diagnostic criteria
- Electing to participate in child or adult partial hospitalization program for eating disorder treatment at MSHMC
- Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than minimally expected.
Key exclusion criteria (10 listed)
- Diagnosis of intellectual disability
- History of known genetic or neurologic disease
- Need for treatment with opioid painkillers
- Weight <25kg
- Inability to swallow pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone Hydrochloride25mg x 3 days then 50mg a day thereafter | Drug | Intervention |
| ControlMethylcellulose and gelatin capsule only | Other | Control |
Primary outcome
ED-15 Score
Time frame: Time Frame: Measured at the following timepoints: enrollment
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
ED-15 Score
Time frame: Time Frame: Measured at the following timepoints: one week
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
ED-15 Score
Time frame: Time Frame: Measured at the following timepoints: three week
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
ED-15 Score
Time frame: Time Frame: Measured at the following timepoints: six weeks
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
ED-15 Score
Time frame: Time Frame: Measured at the following timepoints: nine weeks (last week of treatment)
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
ED-15 Score
Time frame: Time Frame: Measured at the following timepoints: 6 months after enrollment
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
34 secondary outcomes
Eating Disorder Examination Questionnaire Score (EDE-Q)
Time frame: Measured at the following timepoints: enrollment
Eating Disorder Examination Questionnaire Score (EDE-Q)
Time frame: Measured at the following timepoints: one week
Eating Disorder Examination Questionnaire Score (EDE-Q)
Time frame: Measured at the following timepoints: three weeks
Eating Disorder Examination Questionnaire Score (EDE-Q)
Time frame: Measured at the following timepoints: six weeks
Eating Disorder Examination Questionnaire Score (EDE-Q)
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Eating Disorder Examination Questionnaire Score (EDE-Q)
Time frame: Measured at the following timepoints: 6 months after enrollment
Patient Health Questionnaire Score (PHQ-9)
Time frame: Measured at the following timepoints: enrollment
Patient Health Questionnaire Score (PHQ-9)
Time frame: Measured at the following timepoints: one week
Patient Health Questionnaire Score (PHQ-9)
Time frame: Measured at the following timepoints: three weeks
Patient Health Questionnaire Score (PHQ-9)
Time frame: Measured at the following timepoints: six weeks
Patient Health Questionnaire Score (PHQ-9)
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Patient Health Questionnaire Score (PHQ-9)
Time frame: Measured at the following timepoints: 6 months after enrollment
Generalized Anxiety Disorder Screener Score (GAD-7)
Time frame: Measured at the following timepoints: enrollment
Generalized Anxiety Disorder Screener Score (GAD-7)
Time frame: Measured at the following timepoints: one week
Generalized Anxiety Disorder Screener Score (GAD-7)
Time frame: Measured at the following timepoints: three weeks
Generalized Anxiety Disorder Screener Score (GAD-7)
Time frame: Measured at the following timepoints: six weeks
Generalized Anxiety Disorder Screener Score (GAD-7)
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Generalized Anxiety Disorder Screener Score (GAD-7)
Time frame: Measured at the following timepoints: 6 months after enrollment
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Time frame: Measured at the following timepoints: enrollment
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Time frame: Measured at the following timepoints: one week
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Time frame: Measured at the following timepoints: three weeks
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Time frame: Measured at the following timepoints: six weeks
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Time frame: Measured at the following timepoints: 6 months after enrollment
Barratt Impulsiveness Scale (BIS-11)
Time frame: Measured at the following timepoints: enrollment
Barratt Impulsiveness Scale (BIS-11)
Time frame: Measured at the following timepoints: one week
Barratt Impulsiveness Scale (BIS-11)
Time frame: Measured at the following timepoints: three weeks
Barratt Impulsiveness Scale (BIS-11)
Time frame: Measured at the following timepoints: six weeks
Barratt Impulsiveness Scale (BIS-11)
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Barratt Impulsiveness Scale (BIS-11)
Time frame: Measured at the following timepoints: 6 months after enrollment
Percent of Weight Restoration
Time frame: Will evaluate total percent of weight restoration via chart review at 9 weeks
Percent of Weight Restoration
Time frame: Will evaluate total percent of weight restoration via chart review 6 months after enrollment at about 33 weeks
Need For Higher Level of Care
Time frame: Will evaluate need for higher level of care at nine weeks
Need For Higher Level of Care
Time frame: Will evaluate need for higher level of care at 6 months after the end of the study at about 33 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26011054Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: The ED-15. Int J Eat Disord. 2015 Nov;48(7):1005-15. doi: 10.1002/eat.22430. Epub 2015 May 26.
- Background: PubMed 7866415Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Background: PubMed 3950219Smucker MR, Craighead WE, Craighead LW, Green BJ. Normative and reliability data for the Children's Depression Inventory. J Abnorm Child Psychol. 1986 Mar;14(1):25-39. doi: 10.1007/BF00917219.
- Background: PubMed 22193671Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
- Background: PubMed 23027429Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276.
- Background: PubMed 25157017Campbell K, Peebles R. Eating disorders in children and adolescents: state of the art review. Pediatrics. 2014 Sep;134(3):582-92. doi: 10.1542/peds.2014-0194.
- Derived from this study: PubMed 36167287Roden RC, Billman M, Lane-Loney S, Essayli J, Mahr F, Vrana K, Ryan S. An experimental protocol for a double-blind placebo-controlled evaluation of the effectiveness of oral naltrexone in management of adolescent eating disorders. Contemp Clin Trials. 2022 Nov;122:106937. doi: 10.1016/j.cct.2022.106937. Epub 2022 Sep 24.
- Oral naltrexone package insertLink provided by the sponsor.
- DSM-5 Chapter on Feeding and Eating DisordersLink provided by the sponsor.
- Individual participant dataSharing planned: No. No participant data is planned to be shared at the moment to protect patient privacy, as participants are all enrolled in a partial hospitalization program for mental health conditions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary C Roden, MD principal investigator
PennState Health Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Naltrexone Hydrochloride in people with Anorexia Nervosa/Bulimia and Anorexia in Adolescence, run by Rosemary Claire Roden at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED-15 Score (time frame: Time Frame: Measured at the following timepoints: enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05073679, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.