NALTREXONE SUMMARY
Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone hydrochloride has the chemical name of 17-(cyclopropylmethyl)-4, 5α-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride.
Naltrexone hydrochloride tablets are indicated:
In the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Naltrexone
Naltrexone for impulse control disorders in Parkinson disease: a
placebo-controlled study. [2014] of ICDs in PD... CONCLUSIONS: Naltrexone treatment was not efficacious for the treatment of ICDs
Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small,
randomized, double-blind, placebo-controlled, counterbalanced, crossover trial
assessing daily pain levels. [2013] fatigue... CONCLUSION: The preliminary evidence continues to show that low-dose naltrexone
Effectiveness of naltrexone in the prevention of delayed respiratory arrest in
opioid-naive methadone-intoxicated patients. [2013] Acute methadone toxicity is a major public health concern in Iran... Further studies are warranted before the generalization of this approach to other
patient populations.
Naltrexone with or without guanfacine for preventing relapse to opiate addiction
in St.-Petersburg, Russia. [2013] induced craving and have reduced opiate relapse in small clinical trials... CONCLUSIONS: Adding guanfacine to naltrexone did not improve treatment retention
Low-dose naltrexone for the treatment of fibromyalgia: findings of a small,
randomized, double-blind, placebo-controlled, counterbalanced, crossover trial
assessing daily pain levels. [2013] fatigue... CONCLUSION: The preliminary evidence continues to show that low-dose naltrexone
Clinical Trials Related to Naltrexone
Naltrexone for Heavy Drinking in Young Adults [Completed]
In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief
counseling and either naltrexone, a medication that is FDA-approved for the treatment of
alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for
administering low-dose naltrexone, in which daily dosing will be combined with targeted
dosing in anticipation of high-risk situations. The main hypotheses are that daily +
targeted naltrexone will result in greater reductions in frequency of heavy and any drinking
compared with daily + targeted placebo.
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease [Completed]
It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing
endogenous enkephalin levels in subjects with active Crohn's disease. This is especially
important in children who often are suffering from nutritional deprivation which retards
their growth.
The key objectives are to:
1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using
the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,
weight, and pediatric quality of life survey.
2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with
active Crohn's Disease.
3. Assess the potential mechanism by which naltrexone exerts its action by measuring
plasma opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
Low Dose Naltrexone for Glioma Patients [Completed]
To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in
high grade glioma patients undergoing standard chemoradiation
Behavioral Naltrexone Therapy (BNT) for Promoting Adherence to Oral Naltrexone (BNT-oral) vs Extended Release Injectable Depot Naltrexone (Depot-BNT); a Randomized Trial. A Free Treatment for Opiate Abuse. [Completed]
In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the
new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide
initial clinical experience with the new Depot-BNT treatment model, while providing a
rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best
behavioral platform for oral naltrexone (BNT).
The following aims will be addressed:
Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves
drug use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT
with oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key
secondary outcomes including dysphoria, HIV risk behavior, and social functioning.
Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition,
in order to optimize Depot-BNT prior to further testing.
Naltrexone and Hypoglycemia in Type 1 Diabetes [Completed]
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly
and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is
left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe
hypoglycemia can lead to seizures, coma, and even death.
Some people with diabetes do not have early warning signs of low blood sugar. This
condition is called hypoglycemia unawareness. It happens when the body stops reacting to
low blood sugar levels and the person does not realize that they need to treat their
hypoglycemia. This can lead to more severe and dangerous hypoglycemia.
The purpose of this early study is to see if a drug called naltrexone should be studied more
in people with Type I diabetes and hypoglycemia unawareness. This study will show whether
naltrexone could reduce hypoglycemia unawareness. The study will also show, by using
magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows
in the brain when a person is experiencing hypoglycemia.
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Naltrexone has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| Naltrexone review by 60 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | No Side Effects | | Treatment Info |
Condition / reason: | | Multiple Sclerosis |
Dosage & duration: | | 4.5 mg. nightly taken 1 nightly for the period of 8 years (still taking it) |
Other conditions: | | None |
Other drugs taken: | | None | | Reported Results |
Benefits: | | It stopped my Multiple Sclerosis progression. I still take it. There are a lot of MS patients who are using it now. It really works and is a very safe inexpensive drug. |
Side effects: | | I dream a little more. |
Comments: | | It is a FDA approved drug at 50 mg. for Drug dependent patients. It has been used in the 3 to 4.5 mg doses for MS for about 10 years. It has gained popularity in the past 5 years and is undergoing various double blind placebo testing at this time for MS, Crones Disease, Aids, and various other conditions. It is extremely safe in the Lower doses such as 4.5 mg. It is also called LDN, as an abbreviation for Low Dose Naltrexone. Once I started taking it for a few days, my MS symptoms improved and according to my Neurologist, my progression has absolutely stopped. I started taking it in 2000. |
|
| Naltrexone review by 54 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | No Side Effects | | Treatment Info |
Condition / reason: | | Crohn's |
Dosage & duration: | | Starting at 1.5 mg night taken 1 time at night for the period of Just started 1-1/2 months |
Other conditions: | | None |
Other drugs taken: | | Entocort, Pentasa | | Reported Results |
Benefits: | | Within 1/1-/2 months I am now starting on 2 pills at night which is 3 mg.
The pain that I normally get in my chest (from my Crohn's) is gone.
I feel better and I am not as tired. It is a wonder drug and I wish they would run more trials so more people can gain the benefits of this drug. Other drugs started out this way and were tested off label for other diseases, why not LDN. |
Side effects: | | Do not have any |
Comments: | | I start out with 1 pill at night for 30 days, then increase to 2 pills a night for 30 days, then 3 pills a night and that is the maximum of dosage. I am
assuming some people just need the 2 pills a night. Seems to be working great for me. |
|
|
Page last updated: 2015-08-10
|