CLINICAL TRIAL

Naltrexone for Eating Disorders

Recruiting · < 65 · All Sexes · Kansas City, MO

This study is evaluating whether fMRI can be used to measure the effects of opioid antagonism in adolescents with eating disorders.

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About the trial for Eating Disorders

Eligible Conditions
Eating Disorders · Eating, Binge · Disease · Bulimia · Feeding and Eating Disorders · Purging (Eating Disorders)

Treatment Groups

This trial involves 2 different treatments. Naltrexone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Naltrexone
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved

Side Effect Profile for Naltrexone + Supportive Counseling

Naltrexone + Supportive Counseling
Show all side effects
Nausea
24%
Headache
12%
Cold
12%
Dry Mouth
10%
Fatigue
10%
Gastrointestinal Issues
7%
Serious Suicidal Ideation
7%
Vomiting
7%
Muscle Aches
7%
Diarrhea
5%
Stomach Pain
5%
Increased Bowel Movements
5%
Constipation
5%
Sedation
5%
Changes to Vision
5%
Increased Irritability
5%
Loose Stool
5%
Stomach Virus
5%
Toothache
2%
Serious Medical Illness
0%
Psychotic Symptoms
0%
Anxiety
0%
Dizziness
0%
Back Pain
0%
Death
0%
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT00006489) in the Naltrexone + Supportive Counseling ARM group. Side effects include: Nausea with 24%, Headache with 12%, Cold with 12%, Dry Mouth with 10%, Fatigue with 10%.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient takes the same doses of their medication every day and has not changed their medication in the past four weeks. show original
The participant and parent/legal guardian are willing and able to provide informed permission, assent, and consent for the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Study day 1
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Study day 1.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Naltrexone will improve 1 primary outcome and 3 secondary outcomes in patients with Eating Disorders. Measurement will happen over the course of Study day 1.

Exposure
STUDY DAY 1
Maximum plasma concentration of naltrexone
Region of interest (ROI)
STUDY DAY 1
Coordinates with largest %BOLD change
Optimal reward paradigm
STUDY DAY 1
Paradigm (e.g., PFV or MID) resulting in largest %BOLD
% Blood oxygenation level dependent change (%BOLD)
STUDY DAY 1
MRI to detect %BOLD changes pre- and post-opioid antagonist treatment (i.e., naltrexone) within individuals during a food reward and general reward task using regions of interest (ROI) analysis

Who is running the study

Principal Investigator
S. S.
Prof. Stephani Stancil, Assistant Professor
Children's Mercy Hospital Kansas City

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is eating disorders?

Results from a recent paper indicated that the risk of developing an eating disorder in a lifetime was higher than in other Western countries. Eating disorders are a heterogenous disorder in terms of symptoms and severity and prevalence rates differ from country to country. Although the etiology of eating disorders is not fully elucidated, a combination of genetic and environmental factors may play an important role in development.

Anonymous Patient Answer

What causes eating disorders?

Eating disorders must be suspected when a person exhibits at least three of the five following symptoms for at least two weeks: unexplained weight loss more than 10% in the preceding 12 months, concern about the appearance of their body, concern that they are not getting enough food, concern that the quality of food is not good enough, and concern with eating frequency. When the person does not want to eat they should visit their doctor. Dietitians can advise patients based on their particular health and circumstances, to develop healthy eating habits and coping techniques. Furthermore, psychotherapists can offer a range of interventions to make a recovery from an eating disorder a reality.

Anonymous Patient Answer

What are common treatments for eating disorders?

A number of medications, psychotherapy and the GI decontamination therapy are commonly used treatments for eating disorders. However, the use of medications for the treatment of eating disorders may be low.

Anonymous Patient Answer

How many people get eating disorders a year in the United States?

The percentage of women who have ED is higher than the percentage of men. For the first time, estimates of the number of cases of ED in the United States were made. The number of cases will continue to increase, especially among adolescents.

Anonymous Patient Answer

What are the signs of eating disorders?

Some common signs can be divided into eating-related (depression related to low mood), general (appetite loss), nutritional (weight loss, poor balance) and behavioral (self-destructive behavior). These symptoms will have  different levels of severity and can be combined. Some signs can signal eating-disease related behaviors.\n

Anonymous Patient Answer

Can eating disorders be cured?

There is no evidence of a cure for anorexia nervosa or bulimia nervosa. There is some evidence that intensive and intensive-outpatient treatment are effective in achieving remission of anorexia nervosa.

Anonymous Patient Answer

Does naltrexone improve quality of life for those with eating disorders?

Naltrexone treatment was associated with improvements in a number of QoL domains and general QoL. These improvements were significant and were not explained by concurrent improvements in body mass index, depression, or binge eating.

Anonymous Patient Answer

What are the latest developments in naltrexone for therapeutic use?

Naltrexone is effective and well tolerated in treating individuals with opioid-dependent heroin users. Naltrexone may be an effective short-term treatment for opioid dependence, and may be considered as a treatment alternative to long-term abstinence.

Anonymous Patient Answer

What is the latest research for eating disorders?

It is critical to summarize and analyze the latest research for individuals seeking help or support related to eating disorders (EDs). These statistics will let the reader learn more about the current state of research for EDs and help make the best decisions regarding the course of treatment and monitoring of patients over time.

Anonymous Patient Answer

Does eating disorders run in families?

Many of the characteristics of ED-families identified in previous studies also appear to cluster together within family members. However, family members of ED-patients could be identified regardless of their own ED status. In a recent study, findings suggest that even if ED can only be detected at the patient level, there are still important family processes that need to be explored. Clinicians may benefit from incorporating specific assessment tools designed to help the family anticipate and manage ED.

Anonymous Patient Answer

Have there been other clinical trials involving naltrexone?

We searched PubMed in order to highlight other studies involving naltrexone and found that most trials are small and have not led to further development. There are currently two large clinical trials that are recruiting patients (see 'Affective Disorders and Related Disorders (AD/D)': ClinicalTrials.gov:http://clinicaltrials.gov/ct2/show/NCT00293650); (Affective Disorders and Related Disorders (AD/D): ClinicalTrials.gov:http://clinicaltrials.gov/ct2/show/NCT00293650)) and they have been under review by the FDA as of 2018.

Anonymous Patient Answer

Is naltrexone typically used in combination with any other treatments?

This review suggests that NRT treatment, as prescribed, is commonly used with many types of treatment for alcohol use disorders. The use of medication is generally found to be prescribed less frequently than NRT, and with relatively high rates of discontinuation. The findings from this review may provide useful information for other researchers interested in treatment of drinking disorders, so that treatment programs can be designed to optimize the benefit of prescription opioid treatment for alcohol use disorders with both naltrexone and medication prescribed.

Anonymous Patient Answer
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