Low Dose Naltrexone
FDA-approved naltrexone, in a low dose, can boost the immune system — helping those with HIV/AIDS, cancer, and autoimmune diseases.


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Welcome to the Low Dose Naltrexone (LDN) Home Page


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> On this page you can find answers to these questions:
What is low-dose naltrexone and why is it important?
How does LDN work?
What diseases has it been useful for and how effective is it?
How can I obtain LDN and what will it cost?
What dosage and frequency should my physician prescribe?
Are there any side effects or cautionary warnings?
When will the low-dose use of naltrexone become FDA approved?
What can I do to spread the word about LDN?
Who sponsored this website?


> You can go to more detailed information on these linked pages:
The Latest News Concerning LDN
LDN in the Treatment of Autoimmune Disease
LDN in the Treatment of Cancer
LDN in the Treatment of HIV/AIDS

In-depth historical reports on LDN for HIV/AIDS:
"Low Dose Naltrexone in the Treatment of Acquired Immune Deficiency Syndrome," a paper presented in 1988 to the International AIDS Conference in Stockholm, Sweden, describing in detail the 1986 LDN HIV/AIDS clinical study.
"Low Dose Naltrexone in the Treatment of HIV Infection," an informal description of the results in Dr. Bernard Bihari's private practice through September, 1996.
LDN in the Treatment of Multiple Sclerosis
What Others Are Saying About LDN
Further Questions and Answers about LDN
Reliability Problem With Compounding Pharmacies
The Developing Nations Project
LDN Events
Curriculum Vitae for Bernard Bihari, M.D.
Excerpts from Patient Interviews:
LDN and HIV
The Developing Nations Project

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What is low-dose naltrexone and why is it important?
> Low-dose naltrexone holds great promise for the millions of people worldwide facing a possible death sentence from virtually incurable cancers and other diseases.
> In the developing world, LDN could provide the first low-cost, easy to administer, and side-effect-free therapy for HIV/AIDS.
Naltrexone itself was approved by the FDA in 1984 in a 50mg dose for the purpose of helping heroin or opium addicts, by blocking the effect of such drugs. By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Many body tissues have receptors for these endorphins and enkephalins, including virtually every cell of the body's immune system.

In 1985, Bernard Bihari, MD, a physician with a clinical practice in New York City, discovered the effects of a much smaller dose of naltrexone (approximately 3mg once a day) on the body's immune system. He found that this low dose, taken at bedtime, was able to enhance a patient's response to infection by HIV, the virus that causes AIDS. [Note: Subsequently, the optimal adult dosage of LDN has been found to be 4.5mg.]

In the mid-1990’s, Dr. Bihari found that patients in his practice with cancer (such as lymphoma or pancreatic cancer) could benefit, in some cases dramatically, from LDN. In addition, people who had autoimmune disease (such as lupus) often showed prompt control of disease activity while taking LDN.


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How does LDN work?
> LDN boosts the immune system, activating the body’s own natural defenses.
Up to the present time, the question of "What controls the immune system?" has not been present in the curricula of medical colleges and the issue has not formed a part of the received wisdom of practicing physicians. Nonetheless, a body of research over the past two decades has pointed repeatedly to one's own endorphin secretions (our internal opioids) as playing the central role in the beneficial orchestration of the immune system, and recognition of the facts is growing.

Witness these statements from a recent review article of medical progress in the November 13, 2003 issue of the prestigious New England Journal of Medicine: "Opioid-Induced Immune Modulation: .... Preclinical evidence indicates overwhelmingly that opioids alter the development, differentiation, and function of immune cells, and that both innate and adaptive systems are affected.1,2 Bone marrow progenitor cells, macrophages, natural killer cells, immature thymocytes and T cells, and B cells are all involved. The relatively recent identification of opioid-related receptors on immune cells makes it even more likely that opioids have direct effects on the immune system.3"

The brief blockade of opioid receptors between 2 a.m. and 4 a.m. that is caused by taking LDN at bedtime each night is believed to produce a prolonged up-regulation of vital elements of the immune system by causing an increase in endorphin and enkephalin production. Normal volunteers who have taken LDN in this fashion have been found to have much higher levels of beta-endorphins circulating in their blood in the following days. Animal research by I. Zagon, Ph.D., and his colleagues has shown a marked increase in metenkephalin levels as well. [Note: Additional information for Dr. Zagon can be found at the end of this page.]

Bihari says that his patients with HIV/AIDS who regularly took LDN before the availability of HAART were generally spared any deterioration of their important helper T cells (CD4+).

In human cancer, research by Zagon over many years has demonstrated inhibition of a number of different human tumors in laboratory studies by using endorphins and low dose naltrexone. It is suggested that the increased endorphin and enkephalin levels, induced by LDN, work directly on the tumors' opioid receptors — and, perhaps, induce cancer cell death (apoptosis). In addition, it is believed that they act to increase natural killer cells and other healthy immune defenses against cancer.

In general, in people with diseases that are partially or largely triggered by a deficiency of endorphins (including cancer and autoimmune diseases), or are accelerated by a deficiency of endorphins (such as HIV/AIDS), restoration of the body's normal production of endorphins is the major therapeutic action of LDN.


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What diseases has it been useful for and how effective is it?
> Bernard Bihari, MD has described beneficial effects of LDN on a variety of diseases:
Cancers: Other Diseases:
Breast Cancer
Carcinoid
Colon & Rectal Cancer
Glioblastoma
Liver Cancer
Lung Cancer (Non-Small Cell)
Lymphocytic Leukemia
Lymphoma (Hodgkin's and
Non-Hodgkin's)
Malignant Melanoma
Multiple Myeloma
Neuroblastoma
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer (untreated)
Renal Cell Carcinoma
Throat Cancer
Uterine Cancer
ALS (Lou Gehrig's Disease)
Alzheimer's Disease
Behcet's Disease
Celiac Disease
Chronic Fatigue Syndrome
Crohn's Disease
Emphysema (COPD)
Fibromyalgia
HIV/AIDS
Irritable Bowel Syndrome (IBS)
Multiple Sclerosis (MS)
Parkinson's Disease
Pemphigoid
Primary Lateral Sclerosis (PLS)
Psoriasis
Rheumatoid Arthritis
Sarcoidosis
Systemic Lupus (SLE)
Ulcerative Colitis
Wegener's Granulomatosis


> LDN has demonstrated efficacy in hundreds of cases.
Cancer. As of mid-2004, Dr. Bihari reports having treated over 300 patients with cancer that had failed to respond to standard treatments. Of that group, some 50%, after four to six months treatment with LDN, began to demonstrate a halt in cancer growth and, of those, over one-third have shown objective signs of tumor shrinkage.

Autoimmune disease. Within the group of patients who presented with an autoimmune disease (see above list), none have failed to respond to LDN; all have experienced a halt in progression of their illness. In many patients there was a marked remission in signs and symptoms of the disease. The greatest number of patients within the autoimmune group are people with multiple sclerosis, of whom there are now some 400 in Dr. Bihari's practice. Less than 1% of these patients has ever experienced a fresh attack of MS while they maintained their regular LDN nightly therapy.

HIV/AIDS. As of September 2003, Dr. Bihari has been treating 350 AIDS patients using LDN in conjunction with accepted AIDS therapies. Over the past 7 years over 85% of these patients showed no detectable levels of the HIV virus — a much higher success rate than most current AIDS treatments, and with no significant side effects. It is also worth noting that many HIV/AIDS patients under Dr. Bihari's care have been living symptom-free for years taking only LDN with no other medications.

> How is it possible that one medication can impact such a wide range of disorders?
The disorders listed above all share a particular feature: in all of them, the immune system plays a central role — and low blood levels of endorphins are generally present, playing a role in the disease-associated immune deficiencies.

Research by others — on neuropeptide receptors expressed by various human tumors — has found opioid receptors in many types of cancer:

Brain tumors (both astrocytoma and glioblastoma)
Breast cancer
Endometrial cancer
Head and neck squamous cell carcinoma
Myeloid leukemia
Lung cancer (both small cell and non-small cell)
Neuroblastoma and others...
These findings suggest the possibility for a beneficial LDN effect in a wide variety of common cancers.


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How can I obtain LDN and what will it cost?
> LDN can be prescribed by your doctor, and prepared by your local pharmacy.
Naltrexone is a prescription drug, so your physician would have to give you a prescription after deciding that LDN appears appropriate for you.

Naltrexone in the large 50mg size, originally manufactured by DuPont under the brand name ReVia, is now sold by Mallinckrodt as Depade and by Barr Laboratories under the generic name naltrexone.

LDN is now being made available by hundreds of local pharmacies, as well as by some mail-order pharmacies, around the US. Some pharmacists have been grinding up the 50mg tablets of naltrexone to prepare the 4.5mg capsules of LDN; others use naltrexone, purchased as a powder, from a primary manufacturer.

One of the first pharmacies to do so was Irmat Pharmacy in Manhattan. Their recent price for a one-month's supply of 4.5mg LDN (30 capsules) was $38. Irmat will ship it anywhere, in the US or to other countries, and will accept prescriptions from any licensed physician.

> Pharmacies that are good sources of LDN:
Irmat Pharmacy, New York, NY (212) 685-0500
The Compounder Pharmacy, Aurora, IL (800) 679-4667
The Medicine Shoppe, Canandaigua, NY (800) 396-9970
Skip's Pharmacy, Boca Raton, FL (800) 553-7429
Smith's Pharmacy, Toronto, Canada (800) 361-6624



> IMPORTANT: Make sure to specify that you do NOT want LDN in a slow-release form.
Reports have been received from patients that their pharmacies have been supplying a slow-release form of naltrexone. Pharmacies should be instructed NOT to provide LDN in an "SR" or slow-release or timed-release form. Unless the low dose of naltrexone is in an unaltered form, which permits it to reach a prompt "spike" in the blood stream, its therapeutic effects may be inhibited.

> IMPORTANT: Make sure to fill your Rx at a compounding pharmacy that has a reputation for consistent reliability in the quality of the LDN it delivers.
The FDA has found a significant error rate in compounded prescriptions produced at randomly selected pharmacies. Dr. Bihari has reported seeing adverse effects from this problem. Please see our report, Reliability Problem With Compounding Pharmacies. Please see the above list of recommended pharmacies for some suggested sources.


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What dosage and frequency should my physician prescribe?
The usual adult dosage is 4.5mg taken once daily at night. Because of the rhythms of the body's production of master hormones, LDN is best taken between 9pm and 3am. Most patients take it at bedtime.

Rarely, the naltrexone may need to be purchased as a solution — in distilled water — with 1mg per ml dispensed with a 5ml medicine dropper. If LDN is used in a liquid form, it is important to keep it refrigerated.

The therapeutic dosage range for LDN is from 1.75mg to 4.5mg every night. Dosages below this range are likely to have no effect at all, and dosages above this range are likely to block endorphins for too long a period of time and interfere with its effectiveness.

> IMPORTANT: Make sure to specify that you do NOT want LDN in a slow-release form (see above).

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Are there any side effects or cautionary warnings?
> Side effects:
LDN has virtually no side effects. Occasionally, during the first week's use of LDN, patients may complain of some difficulty sleeping. This rarely persists after the first week. Should it do so, dosage can be reduced from 4.5mg to 3mg nightly.

> Cautionary warnings:
Because LDN blocks opioid receptors throughout the body for three or four hours, people using medicine that is an opioid agonist, i.e. narcotic medication — such as Ultram, morphine, Percocet, Duragesic patch or codeine-containing medication — should not take LDN until such medicine is completely out of one's system. In addition, LDN should probably not be taken during pregnancy.

Full-dose naltrexone (50mg) carries a cautionary warning against its use in those with liver disease. This warning was placed because of adverse liver effects that were found in experiments involving 300mg daily. The 50mg dose does not apparently produce impairment of liver function nor, of course, do the much smaller 3mg and 4.5mg doses.


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When will the low-dose use of naltrexone become FDA approved?
> Although naltrexone itself is an FDA-approved drug, LDN still awaits clinical trials.
The FDA approved naltrexone at the 50mg dosage in 1984. LDN (in the 3mg or 4.5mg dosage) has not yet been submitted for approval because the prospective clinical trials that are required for FDA approval need to be funded at the cost of many millions of dollars.

All physicians understand that appropriate off-label use of an already FDA-approved medication such as naltrexone is perfectly ethical and legal. Because naltrexone itself has already passed animal toxicity studies, one could expect that once testing is able to begin, LDN could complete its clinical trials in humans and receive FDA approval for one or more uses within two to four years.


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What You Can Do
> Talk to your doctor.
If you are suffering from HIV/AIDS, cancer, or an autoimmune disease, LDN could help. In AIDS and cancer therapy, LDN is often used in conjunction with other medications.

Cancer. Anyone with cancer or a pre-cancerous condition should consider LDN. Many use LDN as a preventive treatment. Post-treatment, others have been using LDN to prevent a recurrence of their cancer. LDN has been shown in many cases to work with virtually incurable cancers such as neuroblastoma, multiple myeloma, and pancreatic cancer.

HIV/AIDS. As an AIDS drug, LDN leads to far fewer side effects than the standard “AIDS cocktail”. When used in conjunction with HAART therapies, LDN can boost T-cell populations, prevent disfiguring lipodystrophy, and lower rates of treatment failure.

Do not be afraid to approach your doctors — physicians today are increasingly open to learning about new therapies in development. Tell your doctors about this website, or print out and hand them the information, and let them weigh the evidence.

> Tell others.
If someone you know has HIV/AIDS, cancer, or an autoimmune disease, LDN could save them from a great deal of suffering. If they use e-mail, send them the address of this website (www.lowdosenaltrexone.org). Or, print out the site and mail them the information.

> Help spread the word to the media, the medical community, and to developing countries.
Low-dose naltrexone has the potential to reduce the terrible human loss now taking place throughout the globe. It is a drug that could prevent millions of children from becoming AIDS orphans. It is a drug that could be a powerful ally in the war against cancer.

If you or someone you know has connections in the media, the medical community, or to those in developing countries involved in AIDS policy or treatment, please let them know about LDN.

> Raise funds to help run clinical trials.
If possible, consider contributing to the Foundation for Immunologic Research (FFIR), a 501(c)(3) non-profit organization, founded by Bernard Bihari, MD, in order to help assist the implementation of clinical trials for LDN. The goal is to achieve general scientific acceptance of LDN. This, in turn, should lead to international availability for people everywhere. See the Foundation's website.


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About This Website
> This is a not-for-profit website.
This website is sponsored by Advocates For Therapeutic Immunology. The purpose of this website is to provide information to patients and physicians about important therapeutic breakthroughs in advanced medical immunology. The authors of this site do not profit from the sale of low-dose naltrexone or from website traffic, and are in no way associated with any pharmaceutical manufacturer or pharmacy.

> Consult your doctor.
This website is not intended as a substitute for professional medical help or advice. A physician should always be consulted for any medical condition.

> Contact us.
For information on how to contact us with questions or comments, click here.

Please note that no response can be given to individual questions concerning medical symptoms or treatment.


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Additional Information
Bernard Bihari, MD, 29 W. 15th Street, New York, NY 10011; (212) 929-4196.
Click here to see Dr. Bihari's curriculum vitae.
Ian S. Zagon, Ph.D., Professor of Neuroscience and Anatomy, Pennsylvania State University, Department of Neuroscience and Anatomy, H-109, The M.S. Hershey Medical Center, Hershey, PA 17033; office phone: (717) 531-8650; email: isz1@psu.edu (click here and here for Dr. Zagon's websites).

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Footnotes
Roy S, Loh HH. Effects of opioids on the immune system. Neurochem Res 1996;21:1375-1386
Risdahl JM, Khanna KV, Peterson PK, Molitor TW. Opiates and infection. J Neuroimmunol 1998;83:4-18
Makman MH. Morphine receptors in immunocytes and neurons. Adv Neuroimmunol 1994;4:69-82

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www.ldninfo.org

Oh boy...where do I begin. Yikes....no one could be further from the truth on this issue. I will have you know that I am very very against most of that pharmaceutical propaganda and am one of those people that won't even take an aspirin unless entirely necessary. I realize that the Mycoplasma link to diseases might be very important but at the same time so is LDN as it relates to auto immune disorders. Please do your research and when you are going to spread the news about something, please make sure that it is accurate. I'm afraid that you are doing these readers a huge diservice as this therapy could very well be life altering. Do you have an auto immune disorder much less MS? I seriously doubt that you do or you would know just how urgent the need to find something to halt any progress of this horrible disease is. Now as far as liver damage. Are you aware that this possible side effect is from studies that were done using 300mg of Naltrexone? It is currently FDA approved at 50mg and a low dose of this drug is 4.5mg.....approx 66 times less then the tested dose and 11 times less then the FDA approved dose. My doctor said that this dose was almost homeopathic at such a low dose and was not at all afraid to presribe it for me. Thank God is what I say almost 3 years into this therapy and leading a very normal life with no MS problems to speak of. I'd say that this is a good reason to share what I know about this to anyone who will listen don't you? Ok and as far as your reference to me possibly being a pharma guy...well first of all, I am a girl and as I stated, pharmaceutical companies are definitely a thorn in my side and a big hill to hurdle as Naltrexone is out of patent and therefore not on any pharmaceutical companies list to support any sort of clinical trials for MS. Us MS patients are currently seeking out and trying to finance our own studies because we believe that much in this very life affirming therapy.
I am trying to answer your comments as best I can and it is I that must now say that you are forgiven cuz I am quite sure you are not deliberatly trying to sabatoge the information. I must also state that Crohns, while it is terrible disease I'm sure, is not quite as urgent as MS. After all, every attack has the ability to render one disabled. Oh and as far as the comment about trying to get to the bottom of the cause of an ailment. Not at all aware of the cause for Crohns but I suspect that it might very be similar to MS in that the shortage of endorphins might be the root cause. That is where the LDN comes in. I understand your concern but when faced with a choice between some very expensive injectable pharmaceutical and taking one tiny harmless pill daily, I'm opting for the latter.