BOX WARNING
Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses.
Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis.
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NALTREXONE SUMMARY
NALTREXONE HYDROCHLORIDE TABLETS, USP
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.
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NEWS HIGHLIGHTS
Published Studies Related to Naltrexone
Improving clinical outcomes in treating heroin dependence: randomized, controlled trial of oral or implant naltrexone. [2009.10]
CONTEXT: Oral naltrexone hydrochloride effectively antagonizes heroin, but its utility is limited by patient noncompliance. Sustained-release preparations may overcome this limitation. OBJECTIVE: To compare the safety and efficacy of a single-treatment sustained-release naltrexone implant with daily oral naltrexone treatment... CONCLUSIONS: The naltrexone implant effectively reduced relapse to regular heroin use compared with oral naltrexone and was not associated with major adverse events. Clinical Trial Registration anzctr.org.au Identifier: ACTRN12606000308594.
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Naltrexone in Outpatients With Bipolar Disorder and Alcohol Dependence. [2009.08.10]
Background: Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence, violence, increased hospitalization, and decreased quality of life. While naltrexone is a standard treatment for alcohol dependence, no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence...
Targeted naltrexone for problem drinkers. [2009.08]
This study aimed to replicate and extend prior research showing that the targeted use of naltrexone is a useful strategy to reduce heavy drinking. We compared the effects of naltrexone with those of placebo in a sample of 163 individuals (58.3% male) whose goal was to reduce their drinking to safe limits...
Efficacy of oral naltrexone on pruritus in atopic eczema: a double-blind, placebo-controlled study. [2009.08]
AIM: The intent of our study was to determine the efficacy of oral naltrexone, an opioid antagonist, in the treatment of pruritus in patients with chronic eczema... CONCLUSION: Naltrexone is more effective than placebo in the treatment of pruritus in patient with eczema. Naltrexone might be considered as an adjunct treatment in the treatment of pruritus. However, further studies in this aspect are highly fostered.
Predicting the effect of naltrexone and acamprosate in alcohol-dependent patients using genetic indicators. [2009.07]
Acamprosate and naltrexone are effective medications in the treatment of alcoholism. However, effect sizes are modest... It is expected that more effective treatments can be offered when genetic information is used in patient-treatment-matching.
Clinical Trials Related to Naltrexone
Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI) [Active, not recruiting]
The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone as compared with oral naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone as compared with oral naltrexone in reducing alcohol use from baseline levels
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treament: A Pilot Trial [Recruiting]
The goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. Moreover, the use of medications for alcohol dependence among veterans is rare, despite VA treatment guidelines that recommend such use. Finally, when medications are prescribed, patients may have difficulties with adherence.
The primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone [Active, not recruiting]
The purpose of this study is to determine whether, after a period of abstinence, adding 6
weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week
naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence)
treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone
or placebo. All participants will receive alcohol counseling.
Behavioral Therapy Plus Naltrexone for Alcoholism [Active, not recruiting]
This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.
Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence [Recruiting]
The overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 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. |
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Page last updated: 2009-10-20
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