Naltrexone for Eating Disorders (NN-RCT Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Children's Mercy Hospital Kansas City
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests if brain scans can show how naltrexone affects the brain in adolescents with binge/purge eating disorders. Naltrexone may help reduce harmful eating behaviors. Naltrexone is a well-tolerated drug used to help with behaviors like substance use, obesity, and eating disorders.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that your medication regimen has been stable for at least 4 weeks before joining. This means no changes in dose or type of medication during that time.
What data supports the effectiveness of the drug naltrexone for eating disorders?
Research shows that naltrexone, when used in clinical trials, helped reduce binge-purge behaviors in people with bulimia and anorexia nervosa of the bulimic subtype. Additionally, a study found that naltrexone combined with bupropion was effective in reducing binge eating and weight in individuals with binge-eating disorder and obesity.
12345Is naltrexone safe for treating eating disorders?
Naltrexone is generally safe for treating eating disorders, with studies showing it is well tolerated in adolescents and adults. Some patients may experience mild side effects like nausea, but liver function tests in adolescents were normal, indicating no serious safety concerns.
13567How does the drug naltrexone differ from other treatments for eating disorders?
Naltrexone is unique because it targets the opioid reward system in the brain, which may help reduce binge eating and purging behaviors. Unlike standard treatments, it is an opioid antagonist (a substance that blocks opioid receptors) and has shown promise in cases where traditional therapies, like antidepressants, are ineffective.
178910Eligibility Criteria
Adolescents and young adults aged 13-21 with an eating disorder characterized by binge eating and/or purging can join this trial. They must have a stable medication regimen, be able to give informed consent, and not be allergic to naltrexone or pregnant. Those with metal implants incompatible with MRI or recent opioid use are excluded.Participant Groups
The study is testing if fMRI can show changes in the brain's reward system when given Naltrexone, an opioid blocker, compared to a placebo. Participants will randomly receive either Naltrexone or placebo first, then switch to the other after a period of time.
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
All participants will receive both naltrexone and placebo, separated by a washout period, in a randomized, crossover fashion. Those randomized to group A will receive naltrexone then placebo. Those randomized to group B will receive placebo then naltrexone.
Group II: Group AExperimental Treatment2 Interventions
All participants will receive both naltrexone and placebo, separated by a washout period, in a randomized, crossover fashion. Those randomized to group A will receive naltrexone then placebo. Those randomized to group B will receive placebo then naltrexone.
Naltrexone is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Vivitrol for:
- Alcohol dependence
- Opioid use disorder
🇪🇺 Approved in European Union as Naltrexone for:
- Opioid dependence
- Alcohol dependence
🇨🇦 Approved in Canada as Vivitrol for:
- Opioid use disorder
- Alcohol dependence
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Children's Mercy Research InstituteKansas City, MO
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Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
University of Kansas Medical CenterCollaborator
National Institute of Mental Health (NIMH)Collaborator
References
Naltrexone use in the treatment of anorexia nervosa and bulimia nervosa. [2019]Our auto-addiction model suggests that opiate blockade may be therapeutically useful in anorexia nervosa and bulimia nervosa. Naltrexone was administered to out-patient subjects in double-blind clinical trials with randomized cross-over designs. Reduction in binge-purge symptomatology was evident in the naltrexone period over placebo for 18 out of 19 subjects with either bulimia or anorexia nervosa of the bulimic subtype. In every case, the decoding of drug or placebo double blinding confirmed the assessments of both the investigator and the subjects, based on the blind analysis of the data and on their therapeutic response, respectively. Statistical analysis done on the total population and two diagnostic subgroups found highly significant differences.
Rapid response in psychological treatments for binge eating disorder. [2022]Analysis of short- and long-term effects of rapid response across 3 different treatments for binge eating disorder (BED).
Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. [2022]Binge-eating disorder (BED), the most prevalent eating disorder, is associated strongly with obesity and functional impairments. Few evidence-based treatments for BED exist; a pharmacotherapy effective in reducing both binge eating and weight needs to be identified. This placebo-controlled double-blind pilot RCT evaluated the acute effects of naltrexone + bupropion (NB) on BED with obesity and examined the longer-term effects through 6-month follow-up after the discontinuation of medication.
Progress in Developing Pharmacologic Agents to Treat Bulimia Nervosa. [2020]This paper reviews past and current progress in developing pharmacologic agents for the treatment of individuals with bulimia nervosa (BN). We searched the literature and clinical trial registries for compounds studied in BN, the related condition, binge eating disorder (BED), and preclinical models of binge-eating behavior. Drug classes evaluated included antidepressants, antiepileptic drugs, stimulants and other medications for attention-deficit/hyperactivity disorder, opioid antagonists, and weight loss agents, among others. The only available drugs with established efficacy in BN at this time include antidepressants (especially selective serotonin reuptake inhibitors [SSRIs]) and the antiepileptic topiramate, though the efficacy of these compounds is modest at best. The only medications we found currently receiving empirical study in people with BN were fluoxetine, other serotonergic antidepressants, intranasal naloxone, lisdexamfetamine dimesylate, phentermine-topiramate combination, the antiandrogenic oral contraceptive ethinyl estradiol plus drospirenone, and prazosin. Preclinical models suggest that nociceptin receptor antagonists, the selective serotonin 5-HT2C receptor agonist lorcaserin, monoamine stabilizers, and selective orexin-1 receptor antagonists might be helpful. We found no evidence of a drug developed specifically for the treatment of individuals with BN. Future areas for research in the pharmacotherapy of BN are suggested. Importantly, until drugs are developed specifically for eating disorders, drugs developed for other conditions that are centrally acting and associated with beneficial psychotropic effects and/or reduced appetite or weight loss might be considered for repurposing in BN.
An experimental protocol for a double-blind placebo-controlled evaluation of the effectiveness of oral naltrexone in management of adolescent eating disorders. [2023]This double-blind, placebo-controlled study evaluates the effectiveness of oral naltrexone in adolescents and young adults with eating disorders (EDs) characterized by purging with or without binge-eating behaviors. We hypothesize that participants receiving oral naltrexone will demonstrate greater improvements in body mass index in underweight participants and self-reported ED symptomatology compared to placebo.
Opiate antagonists and eating behavior in humans: a review. [2015]Animal studies have demonstrated a robust role for the endogenous opioid system in the control of food intake. In humans, selective opioid antagonists such as naloxone, naltrexone, and nalmefene have been shown in some studies to reduce total food intake by up to 30% and to alter food preferences in short-term experimental trials in normal-weight subjects, as well as in obese and bulimic patients. The value of naloxone and naltrexone in the long-term treatment of eating disordered patients, however, must be considered very limited. The published treatment studies do not justify the routine use of naloxone and naltrexone in patients with Prader-Willi syndrome, obesity, bulimia nervosa, or anorexia nervosa because of their unprofitable risk/benefit ratios, although further work, particularly focused on some of the newer antagonists, should be undertaken.
Naltrexone Reduces Binge Eating and Purging in Adolescents in an Eating Disorder Program. [2020]Objective: Little evidence exists for pharmacologic treatment of binge eating and purging in adolescents with eating disorders. Given the role of the opioid reward system in compulsive binge eating and purging, naltrexone, an opioid antagonist, may be effective in reducing these behaviors. Previous studies have demonstrated that naltrexone reduces binge eating and purging in adults, yet evidence for its use in adolescents is lacking. This case series describes naltrexone utilization, response, and safety in adolescents with eating disorders. Methods: A retrospective chart review of adolescent patients prescribed naltrexone at an academic eating disorder program was completed. Results: Thirty-three adolescents aged 15.3 ± 1.49 years, 94% female gender identity, were treated with naltrexone with the most common expected outcome "to reduce vomiting." Naltrexone was prescribed for 129 ± 125 days. Over half of patients (52%, n = 17) had liver function tests during follow-up, all of which were within normal limits. Three patients (9.1%) experienced nausea related to naltrexone. Just over half of adolescents (67%; n = 22) had documentation of positive naltrexone response (e.g., reduced purging or urge to purge). The mean Clinical Global Impressions-Improvement score was 2.7 ± 1.3 (2 = much improved; 3 = minimally improved). Conclusions: Naltrexone is safe, well tolerated, and effective for the treatment of adolescents with binge eating and/or purging as part of a comprehensive eating disorder treatment plan. Further study is necessary to confirm the effectiveness of naltrexone prospectively and evaluate factors contributing to naltrexone response vs. nonresponse to promote an individualized approach to treatment of binge eating and purging behavior.
Treatment of antidepressant-resistant bulimia with naltrexone. [2019]Ten individuals with antidepressant-resistant bulimia were treated with the long-acting opiate antagonist naltrexone. Seven of the ten experienced at least a 75 percent reduction of their bulimic symptoms, and have maintained their improvement on three to five month follow-up. These preliminary data suggest that naltrexone may be of use in bulimia unresponsive to standard antidepressant therapy, and may provide insight into the role of endogenous opioids in the etiology of eating disorders.
Binge eating disorder: response to naltrexone. [2015]Binge eating disorder (BED) is characterized by a bulimic binge eating pattern without the compensatory behaviors of purging or laxative abuse. It is often associated with obesity. The treatment response characteristics are more like bulimia than other forms of obesity. We have shown the opiate antagonist naltrexone to attenuate bulimia nervosa in controlled clinical trials. We report here a response to naltrexone in a subject with BED similar to that previously reported for the larger population of bulimic subjects. Three consecutive periods of drug, placebo and double dose drug were used, with the order of the first two periods double blind until after the data analysis. Symptoms were reduced in the naltrexone compared to placebo period. Statistical significance was demonstrated using time series analysis for this 'n of one' study. Psychotherapy was carried out throughout all periods. Naltrexone plus psychotherapy may be more efficient than psychotherapy alone.
A detailed longitudinal analysis on the use of naltrexone in the treatment of bulimia. [2019]In accord with our auto-addiction opioid model, naltrexone was previously reported to be effective in the treatment of bulimia in a controlled double-blind clinical trial with a randomized cross-over design. This is a detailed longitudinal analysis over a 16 month period of one subject from that study. Attenuation in bulimic symptoms in two-drug as compared to no-drug periods was demonstrated. The duration for which the drug was needed was also addressed. The subject is an illustration of a therapeutic response on multiple parameters including binges, purges, urges to perform both behaviors, eating patterns, scaled feelings and Eating Disorder Inventory questionnaire scores. A rare allergic reaction to the drug is reported. It appeared to be heat and photosensitive, even in the presence of sun screen, occurred after a delay and did not appear immediately on skin testing. Use of naltrexone after desensitization is also reported.