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Low Dose Naltrexone for Longevity


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#181 ajnast4r

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Posted 24 April 2010 - 02:10 AM

whats the deal with allergies and LDN? does it make them better or worse? theres contradicting info in this thread.

#182 FunkOdyssey

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Posted 27 April 2010 - 02:49 PM

Funk, on weekends I go out to the bars at around 11 pm and get back home at around 3am, sometimes mildly inebriated (3 beers) and with company. So my question is if there's any problem taking LDN at 10: 30 pm just before going out. Potential problems I have in mind:

- 1. the gap between taking it and actually getting into sleeping (4 hours or so);
- 2. any chance that it would interfere with sexual performance that night?
- 3. (alcohol interaction - you told me already that this is not a problem really)

I would not take it before you go out -- just take it when you go to sleep, whenever that may be. It will not interfere with sexual peformance at any time in relation to dosing. If its in your system while you are drinking alcohol it will limit your enjoyment of drinking.

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#183 FunkOdyssey

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Posted 27 April 2010 - 02:50 PM

whats the deal with allergies and LDN? does it make them better or worse? theres contradicting info in this thread.

Search "allergies" on the LDN yahoo group, you'll see the vast majority reporting improvements. This hasn't been studied yet but the anecdotes are clearly in favor of reduced allergic responses.

#184 Chaos Theory

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Posted 28 April 2010 - 04:02 PM

I'm currently on day 2 of my second attempt at LDN. The effects today seem the same as the last time I tried it. Instant increase in libido. Higher energy, but an anxious, on-edge type of energy. It helps in the gym but does not feel too good otherwise.

As far as negatives I just feel a bit anxious and on-edge all day. Not in an overstimulated kind of way. More like unable to relax. Not really a pleasant feeling. Sleep was also terrible the first night, and slightly less so last night.

I only took .25mg-.5mg.

I like the extra energy but personally I think straight stimulants would feel cleaner. Any chance of the anxiety subsiding?

#185 FunkOdyssey

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Posted 28 April 2010 - 04:13 PM

I like the extra energy but personally I think straight stimulants would feel cleaner. Any chance of the anxiety subsiding?


Absolutely, give it some time. I bet by day five its gone.

#186 Chaos Theory

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Posted 28 April 2010 - 07:51 PM

Do you guys notice dry skin when starting LDN? I remember from my first trial it messed my skin up. Coincidentally the first day after taking it again I woke up with really dry skin. I chalked it up to the lack of sound sleep which always makes skin look worse. Medications in general can have this effect though, and I'm hoping with LDN that's not the case.

#187 Berama

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Posted 30 April 2010 - 08:30 AM

Anyone out there with migraine, taking ldn?

I've gone down from a dose of 4 mg to 2 mg and am still getting migraines so I think that's the end of ldn for me. Such a shame because when I don't have migraine - it's amazing - never felt better.

Would love to know why it's making them worse.

#188 zeropoint

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Posted 30 April 2010 - 02:38 PM

Maybe helpful some stuff:

From Dr.Bob.org:
The second list is for discussion of starting with very low doses, as low as 0.1 mg and increasing by 0.25mg increments to minimize side effects for those who have had issues due to being very sensitive or due to accumulation.

We also discuss Dr Zagon's ideas on skipping days
between doses, based on his animal studies. Many report improved results with skipping days. And with starting out very low, most are starting at 0.5 mg. Some do not go beyond 1 mg, which is actually in opposition to the Bihari Protocol which says that less than 1.75 mg is not effective.

Regarding this idea the occurence of vivid dreams at even 0.5 mg implies that less that even 0.5mg of LDN is doing something at even this very low dose.

As reported by many LDN users it may take 4 - 6 months to notice results and up to 18 months to reach maximum benefit. I have noticed some threads on this board where people quit after just three weeks, or never try lowering the dose or skipping days between.

Many have noted increased benefits and lessened side effects with doses in the 1 - 2 mg range over
2.5 - 3 mg. No longer is 3.0 - 4.5 mg considered the optimal dose range for all. There is much variation, thought to possible be due to tissue accumulation or individual sensitivity.

Your welcome Deneb. I just wanted to set the record straight as many seemed to have some common misconceptions about Low Dose Naltrexone. It is a very beneficial therapy for the vast majority of users. The statistics quoted in regard to those who benefit were also inaccurate with some 70 - 90%, depending on how you are measuring, of users do find it effective.

About 10 - 20% will experience mild transient side effects such as sleep disturbance and vivid dreaming, among others. Most of these pass quickly and are often avoided by starting with a very low dose and increasing gradually.

Many use a natural sleep aid such as Melatonin, GABA, Tryptophan, Herbal Sleep Aids or at times prescription sleep aids. Personally I find Melatonin adequate for this. Although I do use a combination of a sustained release and a fast release sub lingual Melatonin to work the best for me.

Please everyone remember to sign the EU Petition. And tell your friends and networks about LDN and the Petition. Our power to overcome the disinformation from Big Pharma is to spread the word directly!

Anyone in any country can sign so please help us promote the human right to access and full disclosure by physicians of information on the benefits of LDN in MS. HIV/AIDS, Autism and all autoimmune diseases and some Cancers.

Many people take it for Hashimoto's Thyroiditis as far as I know. There is a Thyroid list that discusses it, among other treatments. And the main list has reports of many people having to reduce their Thyoid supplement after starting LDN, not sure of the time frame, some rather quickly if memory serves.

Increased libido and decreased hot flashes have been reported by some. Dr Jaquelyn McCandless, who is 75, takes it and has all her patients over 60 take it. She is also running an HIV/Aids trial in Mali, Africa. As well as modertaing two LDN Yahoo lists, one for Autism and one for HIV/AIDS.

She is a neuro psychiatrist who became involved in LDN when one of her grandchildren was diagnosed with Autism. She wrote a book called Chilren With Starving Brains.

Many take LDN for prevention of degenerative and infectious diseases. Personally my hot flashes have lessened, not eliminated yet but it has not been that long. Arthritis is better. I have not had a cold or the flu since taking it -- used to get every thing that went around. I take 2.0 mg every three or four days. Worked up slowly though from 0.5 mg, increasing by 0.25 mg every two weeks.

I am a big fan of LDN. My first trial with it ended in failure when I tried to increase higher from 1.5mg after 2 weeks. Knowing what I know now, my optimum dose is probably 1.5mg max, less maybe better, every other day instead of daily makes a lot of sense to try too. I also discovered that taking in the prescribed timeframe (9pm-midnight) was too late. It worked better for me if taken around 7pm-8pm. Everyone's body clocks and biochemistries are different, so some experimentation makes sense. One size rarely fits all, I think.

There are few pills, herbs, or supplements that have the potential to benefit a wide variety of ailments from A to Z, but I think LDN is one of them, if not the only one.

The common side effect of sleep disturbance I think I only had for one night. After that my sleep was greatly improved. Anxiety went to zero. Social comfort in a crowd was perfect. Very peaceful even in a heated argument. More energy. More clear-headed instead of brain fog. Better moods, that came in sporadic waves (probably a hint of improvement beginning). But 3mg definitely worsened my depression and erased all the gains I had made on 1.5mg. Scared me off.

So a retry is definitely in order.

You are not the first person I have found that had problems when they tried to go to 3 mg. Whether it is a matter of how fast you are increasing or how often you are dosing, or the actual dose I am not clear.

I started the Very Low Dose Naltrexone list to try and collect all of these stories on one list, share experiences and see if putting our heads together might not lead to new solutions for those who encounter difficulties with the Bihari Protocol.

Some people actually prefer to take their LDN in the morning. There are two endorphin peaks every 24 hours, one around 3 AM and one around 1 PM. The idea is to reach peak plasma levels of LDN, which takes about an hour, maybe less if you are using liquid or cream, by the time the endorphin levels are peaking.

But results are what tells the real story so I am with you on playing around until you find what works for you. As I have often said in relation to LDN you can not argue with success.

Thanks for your comments.

Everyone's endorphins peak at the same time, with the night time peak around 3 AM being larger and the afternoon peak around 1 PM being smaller.

If it is interfering with your schedule taking it in the evening then try to take it in the morning,
between 9 and 11 AM, should produce a peak blood level in time to affect the endorphin production at 1 PM.

There are people who only take LDN twice a week or every other day, and they still benefit.

Dr Ian Zagon has stated that twice a week may be all that is needed, based on his research in animal models with LDN and Met5enkephaline, the main endorphin that is increased and through which LDN seems to work.

Due to tissue accumulation and variance in rate of clearing LDN some people do better taking it every other or every three days.

There are no clinically available tests for endorphins yet. They are limited to research environments, so yes they exist but not for patients unless you are in a study.

#189 adamh

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Posted 30 April 2010 - 07:12 PM

Very good info especially the part about it taking 6 months to give results for some people and up to 18 months. I've been experimenting with it for about a month. I started with .5 mg which was a little too much. I am now at .25 which may be about right. I might try upping it later on. I may try taking it every other day. I've been skipping 1 to 3 days a week.

I tried taking it late in the day and it interfered with sleep. It seems to peak at around 2 to 4 hours after taking it with food. It does not wear off very fast. The benefits I've noticed so far are that my sinuses are not acting up as much as they did. Also, I seem to get a lot more done now days. I guess thats the motivation they speak of. I have enough for years at my present rate so I'll keep it up at least until the end of the year.

#190 Chaos Theory

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Posted 11 May 2010 - 03:34 PM

Well I had to abort my second attempt to acclimate to an LDN regimen. My sleep has always been very fragile, mostly when it comes to shutting off and falling asleep. I have no trouble staying asleep.

The LDN just seems to make it impossible for me to get to sleep. It still feels great for the first couple days. More energy in the gym and higher libido. However after a week of lost sleep all of the benefits are negated and it seems to put me in a terrible mood. That was only using .25-.5mg.

I do want to give it another try at some point. Especially once more research comes out on LDN.

#191 adamh

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Posted 14 May 2010 - 07:52 PM

CT, I can relate to that very well. I love the benefits; improved mood, more energy, getting things done and so on. And my sinuses are not bothering me. But the sleep issues were a major issue. I went down to 0.25 mg once every 2 days and I got to where I was sleeping ok. But then the benefits started fading out. Mood was not as great and sinuses started acting up a little. I'm now at 2 days on and then skip a day. That seems to work and I hope I will be able to acclimate to the side effects. Can anyone describe side effects besides sleep issues?

I've been taking stuff for sleep. An over the counter pill, which I use about 2x per week. Phenibut which I use less than 1x per week. Hops herb which helps some and molungu tea which helps some. I am ordering scullcap, black cohosh, lemon balm and wild lettuce, all of which are reputed to help with sleep. I figure to rotate them so that they don't lose effectiveness. I also take ashwaganda and bacopa

Unfortunately, I also take piracetam, ala, and alcar all of which have stimulating effects. So I need something to calm me down. I figure each herb will do something different so I won't build up a tolerance to any one. I hope to build up to .5 mg per day after a while.

#192 adamh

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Posted 27 May 2010 - 06:55 PM

I went down to .25 mg per day and the sleep issues seemed to fade mostly away but so did most of the benefits. I'm back to .30 mg per day and no problems and seem to have more energy and some motivation. Sinuses are not too bad. I plan to go to about .35 a day in a few days time and gradually ramp up.

One thing I noticed was it's easier to stay on my diet now. I'm dropping about 5 lb per month. This is what you might expect on a stimulant. Anybody else notice this? I'm not overweight but do have some excess body fat. I could lose another 10 lb and look leaner. If I lost 20 lb I would look really cut but that might be too much. I want to maintain muscle and even increase so I don't want to diet too hard. This makes it easier.

#193 debu

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Posted 15 July 2010 - 09:52 PM

been reading around about LDN and it has me interested. Questions: if I source it from someone other than my doctor I'm going to run into problems finding a place to compound it down to low-dose levels right? I haven't read the whole thread here for a while, is it possible to do this on your own (basic chemistry knowledge) in some sort of suspension? thanks

#194 FunkOdyssey

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Posted 15 July 2010 - 09:55 PM

been reading around about LDN and it has me interested. Questions: if I source it from someone other than my doctor I'm going to run into problems finding a place to compound it down to low-dose levels right? I haven't read the whole thread here for a while, is it possible to do this on your own (basic chemistry knowledge) in some sort of suspension? thanks


50mL distilled water + 50mg tablet = 1mg/mL. More detailed instructions available anywhere LDN is discussed including multiple times previously on this forum.

#195 debu

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Posted 15 July 2010 - 09:59 PM

been reading around about LDN and it has me interested. Questions: if I source it from someone other than my doctor I'm going to run into problems finding a place to compound it down to low-dose levels right? I haven't read the whole thread here for a while, is it possible to do this on your own (basic chemistry knowledge) in some sort of suspension? thanks


50mL distilled water + 50mg tablet = 1mg/mL. More detailed instructions available anywhere LDN is discussed including multiple times previously on this forum.


I came back to the end of the thread to edit that I'd found the info within the thread. You're quick on the trigger! ;) thanks

#196 aLurker

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Posted 16 July 2010 - 01:02 AM

Very interesting thread.
But is LDN viable long-term? Does tolerance build up and do the positive effects fade? Is it healthy to do this indefinitely (especially since it might affect sleep quality)? Any good studies on this?

This entire study for instance reads like a commercial for LDN. It might have been mentioned before but here is the abstract:

Low-dose naltrexone for disease prevention and quality of life.
Brown N, Panksepp J.

Department of Humanities and Social Sciences, Embry-Riddle Aeronautical University, Daytona Beach, FL 32114, United States. NPHbrown@aol.com
Abstract

The use of low-dose naltrexone (LDN) for the treatment and prophylaxis of various bodily disorders is discussed. Accumulating evidence suggests that LDN can promote health supporting immune-modulation which may reduce various oncogenic and inflammatory autoimmune processes. Since LDN can upregulate endogenous opioid activity, it may also have a role in promoting stress resilience, exercise, social bonding, and emotional well-being, as well as amelioration of psychiatric problems such a autism and depression. It is proposed that LDN can be used effectively as a buffer for a large variety of bodily and mental ailments through its ability to beneficially modulate both the immune system and the brain neurochemistries that regulate positive affect.



#197 atar

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Posted 18 July 2010 - 02:27 PM

Naltrexone does make you feel miserable -- that's why they take it at bedtime, so it hits you while you're sleeping. They're after the rebound effect that comes when the opioid receptors become more sensitive or more endogenous opioids are produced in response to naltrexone's antagonism.

I prescribe LDN for treatment refractory patients and found out that sometimes people have difficulty on falling asleep, taking it during morning time reduces the sleep-related side effects and will not create much problems in doses between 3-4.5 mg!

#198 atar

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Posted 18 July 2010 - 02:31 PM

I'm currently on day 2 of my second attempt at LDN. The effects today seem the same as the last time I tried it. Instant increase in libido. Higher energy, but an anxious, on-edge type of energy. It helps in the gym but does not feel too good otherwise.

As far as negatives I just feel a bit anxious and on-edge all day. Not in an overstimulated kind of way. More like unable to relax. Not really a pleasant feeling. Sleep was also terrible the first night, and slightly less so last night.

I only took .25mg-.5mg.

I like the extra energy but personally I think straight stimulants would feel cleaner. Any chance of the anxiety subsiding?

That is highly interesting to me, what was the exact dose you were taking? Most clinical trials report only sleep related side effects.

#199 atar

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Posted 18 July 2010 - 02:55 PM

Shepard, are you currently on selegiline, or are you considering stacking selegiline and LDN?


I am not. I do have some at my disposal, though.

What would a MAO-I as selegiline ad to an opioid antagonist??? This boggles my pharmacological brain, please enlighten me...

#200 nito

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Posted 19 July 2010 - 09:10 AM

Just finished reading the whole tread and it seems pretty interesting. I gathered that it can help someone who does not have any particular problems and is otherwise healthy with feeling more motivated and energetic. I wouldn't mind that at all as my depression seems to have killed both! Is there anyone from the UK who has ordered this and did they need a prescription? Any cheap sources perhaps?

Cheers

#201 nito

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Posted 26 July 2010 - 08:46 PM

seems like the thread has died out a bit sadly lol.

#202 adamh

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Posted 27 July 2010 - 12:56 AM

I slowly built up to about .7 mg per day and the side effects are about the same as on .25, iow they aren't too bad. I do get enhanced libido, a reduction in my allergy related sneezing and I'm not sure what else. Nothing as far as helping nerve pain which was the main reason. I'll keep building up but if I hit 1.5 per day and nothing happens I'm sure I will quit. But it costs very little which is good. I may try gabapentine after this but I don't want to use both at the same time. Anyone know a better source than airsealed?

I still can't say I notice much of the crappy feeling some people have reported. I take it in the morning to lessen the sleep interference.

#203 aLurker

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Posted 27 July 2010 - 08:56 AM

Shepard, are you currently on selegiline, or are you considering stacking selegiline and LDN?


I am not. I do have some at my disposal, though.

What would a MAO-I as selegiline ad to an opioid antagonist??? This boggles my pharmacological brain, please enlighten me...


You are correct in that it probably wouldn't interfere that much although it's debatable whether this was implied in the first place. I'd like to know how this stacks anyway. Deprenyl has a tendency to interfere with just about everything even when the mechanisms are somewhat unclear. The primary mechanisms for Deprenyl and LDN are vastly different yet the resulting consequences of both of these might be interesting. Dopamine and endorphins do affect each other in our brains and whether or not the resulting interplay would have synergy or not is unclear to me. I can't really see any theoretical dangers with this combo. I've just started taking Deprenyl and I'm considering an order of Naltrexone to give this a try so any input about them in combination would be welcome.

#204 nowayout

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Posted 10 September 2010 - 11:39 PM

That sounds awfully expensive. And someone told me I paid too much. Try all day chemist. You do need a script which you say you already have.


No, you don't require a script at all day chemist.

There is a place to fill in script details, but you don't have to fill them out. They send you the medication anyway.

You could also try united pharmacies. They may be cheaper depending on what you buy - their postage and handling is way cheaper.

Edited by viveutvivas, 10 September 2010 - 11:51 PM.


#205 nowayout

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Posted 10 September 2010 - 11:50 PM

Has anybody taken LDN in combination with opiods like Tramadol?

I have been on Tramadol for almost a year now for refractory lower back pain. I know that ideally it is recommended to get off opioids before starting LDN. However, right now I am taking the maximum daily dose of Tramadol because I need it - due to the pain I cannot imagine being able to fall asleep without it. I am actually hoping that LDN could perhaps reduce my need for the painkillers, which have become less effective over time, even if it doesn't eliminate it entirely.

Edited by viveutvivas, 10 September 2010 - 11:53 PM.


#206 adamh

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Posted 07 October 2010 - 06:46 PM

I gradually increased my intake of L and now am taking 1.6 mg per day. The sleep disturbance has not gotten worse nor has it seemed to get better. One new thing I'm noticing is the brain fog that others have commented on. I couldn't figure it out, I was fine in the morning and then later groggy and foggy. It starts about 2 or 3 hours after I take it so I did not make the connection at first. Plus it didn't do that at smaller doses. It seemed like when I got close to 1.5 mg it started up. I will try taking it later in the day.

Still no benefits for my nerves yet. My allergy seems to have mostly gone away which is a good thing. I just started taking astragalus root. One screw said he uses it and reported benefits from the ldn which he also takes. It may have been a combination of the ldn and astragalus or the astragalus by itself. The fact ast makes you sleepy makes it interesting to me. I've had enough of compounds that make you hyped up. So I haven't given up, I'll keep on with the ldn at least until the end of the year. Ast has a long list of supposed health benefits so I guess I can't go wrong, can I?

How you doing, Lurker?

#207 aLurker

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Posted 07 October 2010 - 07:02 PM

I gradually increased my intake of L and now am taking 1.6 mg per day. The sleep disturbance has not gotten worse nor has it seemed to get better. One new thing I'm noticing is the brain fog that others have commented on. I couldn't figure it out, I was fine in the morning and then later groggy and foggy. It starts about 2 or 3 hours after I take it so I did not make the connection at first. Plus it didn't do that at smaller doses. It seemed like when I got close to 1.5 mg it started up. I will try taking it later in the day.

Still no benefits for my nerves yet. My allergy seems to have mostly gone away which is a good thing. I just started taking astragalus root. One screw said he uses it and reported benefits from the ldn which he also takes. It may have been a combination of the ldn and astragalus or the astragalus by itself. The fact ast makes you sleepy makes it interesting to me. I've had enough of compounds that make you hyped up. So I haven't given up, I'll keep on with the ldn at least until the end of the year. Ast has a long list of supposed health benefits so I guess I can't go wrong, can I?

How you doing, Lurker?


I'm not on LDN right now. Didn't seem worth it for the minor problems I was hoping it would help, I didn't notice much except perhaps slightly elevated mood and I didn't feel sure it was a good idea in the long run for me to take LDN when delayed sleep phase is a bigger issue for me. The melatonin seems to help against that though. I might give LDN a shot later on though but it isn't on my list of priorities since it isn't all that relevant to my issues which are more ADD-related and it didn't seem to help me in that area.

Good luck and I hope you get better!

#208 nowayout

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Posted 07 October 2010 - 10:48 PM

I started LDN a couple of weeks ago and only did a single dose of 3mg.

For a few hours after, I felt like death. Hugely magnified unbearable back pain, shivers, malaise.

I have not taken any more since then. I was hoping that it would help my constant back pain, but for those few hours it magnified the pain so much that I am afraid to repeat the experience.

LDN is often recommended for conditions of chronic pain. How do people with chronic pain conditions deal with the initial increase in pain? I am talking here of pain at level 10 on a scale of 0-10 while the LDN was having its effect.

Edited by viveutvivas, 07 October 2010 - 11:02 PM.


#209 adamh

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Posted 07 October 2010 - 11:34 PM

Viv, I never heard that part about it helping pain. That may well be but it's a new one on me. Where did you hear that? I have back problems too but I don't expect anything from ldn.

It blocks opiates so it could initially increase your discomfort. Are you taking anything for pain? It would tend to block the action if its opiate like. Or just blocked your natural opiods. The thing about it is it gradually does the opposite and sensitizes you to endogenous opiates after you quit using it or even while still using. I would say try a lower dose and work your way up. Try .5 mg for a few days, then 1, then perhaps 1.5 and so on.

Lurker, perhaps piracetam would help you in conjunction with choline?

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#210 nowayout

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Posted 08 October 2010 - 01:47 AM

Viv, I never heard that part about it helping pain. That may well be but it's a new one on me. Where did you hear that?


At http://www.lowdosenaltrexone.org/ it is claimed to be effective for symptoms of

  • Fibromyalgia
  • Ankylosing spondylitis
  • Rheumatoid Arthritis
and a long list of other painful conditions. It makes sense that the rise in endogenous endorphin metabolism would reduce pain. it is also known to enhance analgesia and reduce tolerance when used with opioids.

Pain med. 2009 May-Jun;10(4):663-72. Epub 2009 Apr 22.


Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study.
Younger J, Mackey S.

School of Medicine, Department of Anesthesia, Division of Pain Management, Stanford University, 780 Welch Road, Suite 208, Palo Alto, CA 94304-1573, USA. jarred.younger@stanford.edu


Abstract
OBJECTIVE: Fibromyalgia is a chronic pain disorder that is characterized by diffuse musculoskeletal pain and sensitivity to mechanical stimulation. In this pilot clinical trial, we tested the effectiveness of low-dose naltrexone in treating the symptoms of fibromyalgia.

DESIGN: Participants completed a single-blind, crossover trial with the following time line: baseline (2 weeks), placebo (2 weeks), drug (8 weeks), and washout (2 weeks).

PATIENTS: Ten women meeting criteria for fibromyalgia and not taking an opioid medication.

INTERVENTIONS: Naltrexone, in addition to antagonizing opioid receptors on neurons, also inhibits microglia activity in the central nervous system. At low doses (4.5 mg), naltrexone may inhibit the activity of microglia and reverse central and peripheral inflammation.

OUTCOME MEASURES: Participants completed reports of symptom severity everyday, using a handheld computer. In addition, participants visited the lab every 2 weeks for tests of mechanical, heat, and cold pain sensitivity.

RESULTS: Low-dose naltrexone reduced fibromyalgia symptoms in the entire cohort, with a greater than 30% reduction of symptoms over placebo. In addition, laboratory visits showed that mechanical and heat pain thresholds were improved by the drug. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient. Baseline erythrocyte sedimentation rate predicted over 80% of the variance in drug response. Individuals with higher sedimentation rates (indicating general inflammatory processes) had the greatest reduction of symptoms in response to low-dose naltrexone.

CONCLUSIONS: We conclude that low-dose naltrexone may be an effective, highly tolerable, and inexpensive treatment for fibromyalgia.


J Pain. 2006 Dec;7(12):937-46.


Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain.
Webster LR, Butera PG, Moran LV, Wu N, Burns LH, Friedmann N.

Lifetree Clinical Research, Salt Lake City, Utah, USA.


Abstract
Physical dependence or withdrawal is an expected effect of prolonged opioid therapy. Oxytrex (oxycodone + ultralow-dose naltrexone) is an investigational drug shown here to minimize physical dependence while providing strong analgesia with twice-daily dosing. In this 719-patient, double-blind, placebo- and active-controlled Phase III clinical trial in chronic low back pain, patients were randomized to receive placebo, oxycodone qid, or oxytrex qid or bid. Each oxytrex tablet contains 1 microg naltrexone; oxytrex bid and qid treatments provide 2 and 4 microg naltrexone/day, respectively. Following a washout, patients with pain >or=5 on a 0-10 scale were dose-escalated weekly from 10 up to 80 mg/day until reaching adequate pain relief (<or=2) or a tolerable level of side effects. Following titration, the dose was fixed for 12 weeks. Active treatment groups attained comparable analgesia despite significantly lower drug use (P = .03) by oxytrex patients. Patients taking oxytrex bid reported 55% less physical dependence than patients on oxycodone (P = .01) by the Short Opiate Withdrawal Scale 24 h after treatment cessation. Oxytrex bid patients also reported decreased moderate-to-severe constipation (by 44%, P = .01), somnolence (by 33%, P = .03), and pruritus (by 51%, P < .001). This is the first large well controlled study to show strong analgesia with minimal withdrawal symptoms and better safety compared with oxycodone. PERSPECTIVE: Previous clinical data have shown ultralow-dose naltrexone enhances and prolongs oxycodone analgesia, and preclinical data also show a suppression of opioid tolerance and dependence. A cellular mechanism of action has been demonstrated to be the prevention of aberrant G protein signaling by mu opioid receptors caused by chronic opioid administration.


Edited by viveutvivas, 08 October 2010 - 01:48 AM.





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