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PostPosted: Sat Feb 11, 2017 10:56 pm 
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Hey gang! As part of my schooling I'm reading through a lot of ASAM (American Society of Addiction Medicine) material. I found a paragraph that may be of interest to those who are switching from methadone to buprenorphine products.

"Induction
The buprenorphine monoproduct and Suboxone film
are the only medications approved by the US FDA for
induction. However, other forms of the combination product
have been used by clinicians in patients addicted to short-acting
opioids without other complications. Because of concern
that sublingually-absorbed naloxone could increase the
risk of precipitated withdrawal, treatment initiation with
buprenorphine monoproduct is recommended for patients
transitioning from methadone and any other long-acting
opioid
, and patients with hepatic impairment."

So the actual recommendation for those transitioning from methadone or any long-acting opioid is buprenorphine by itself, not buprenorphine/nalaxone, or in other words, not suboxone! Now this is for the induction part only, not maintenance, but I had never heard of this recommendation before reading this section of the ASAM National Practice Guidelines For the Use of Medications In the Treatment of Opioid Use Disorders, page 33.

Has anyone else noted this recommendation from any source, in writing or conversation?

Amy

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PostPosted: Sat Feb 11, 2017 11:57 pm 
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Quote:
Because of concern
that sublingually-absorbed naloxone could increase the
risk of precipitated withdrawal,..


Hi Amy,

Very interesting. I've been under the strong impression naloxone would not
increase this risk. Be great to hear from others on this. Maybe we'll be fortunate
enough to hear from Dr. J again, or Doc.


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PostPosted: Sun Feb 12, 2017 2:05 am 
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Very cool find, Amy.


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PostPosted: Sun Feb 12, 2017 2:31 am 
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No, never ran into it.
Just my half a penny... seems insignificant to due tiny sublingual/buccal (cheek)/GI absorption.
I happened to spend the last few hours reading clinical trials including bup, bup/nal and naloxone in public or private companies drug investigations. Yesterday, Braeburn cancelled it's Initial Public Offering to become a publically traded company . They make the Probuphine implant. They'll likely have the weekly and monthly bup depot out Q3-4 2017 if they beat Indivior's monthly depot, maker of Suboxone.

Because of the opiate crisis, naloxone, as a HIGH dose stand-a-lone product, is skyrocketing in price which gets companies interested in $$$$. They avoid developing oral formulations due to the tiny and slow sublingual/buccal (cheek)/GI absorption and what does survive - the liver takes care of. Companies are interested in IV, IM, Subcu and nasal. less so rectal.

The practical aspect is that while ASAM might think plain bup is best for methadone transitioners, given some new 2017 state laws requiring plain bup only for pregnant females, and many other state medical boards and Drs Clinic's rules agreeing, this idea may not be feasible to promote.

Hopefully one of the Drs. will opine. Best!! P
PS edited this for clarity, thanks Godfrey!

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Last edited by Pelican on Sun Feb 12, 2017 11:15 am, edited 1 time in total.

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PostPosted: Sun Feb 12, 2017 9:17 am 
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Thanks as always Pelican. I could even follow most of that :D Had to look up
buccal though.

(Are you an investor of some sort by the way? My one big score....in a lifetime of stock market mediocrity...
was buying Sarepta. This was some months back now, when the WSJ started writing about the bureaucratic idiocy at the FDA WRT to their new drug to treat Duchenne's. Of course I was very
lucky, but the fact that Janet Woodcock seemed so supportive persuaded me to take a flyer.)


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PostPosted: Sun Feb 12, 2017 11:32 am 
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In today's world the likelihood I could get a prior authorization from a pharmacy benefits company for plain buprenorphine in order to do an induction is highly unlikely. Generally it takes two appeals if I want to try it for side effects I think may be from the Naloxone. In order to use plain buprenorphine it would have to be done by the treatment center that is providing the methadone.
As of yet, we have no state law or guideline that would prohibit its use.
I suppose there are a few clinics that have jumped through the DEA hoops in order to purchase, keep on site and dispense buprenorphine products on site that would be able to do this as well.
Not that these products are singled out: there are a lot of regulatory requirements for storing, administering or dispensing any controlled substance.
I don't think the amount of Naloxone in the Suboxone products is enough to be of any clinical concern, more of a theoretical possibility. The PW, if it is going to occur will be driven by the Buprenorphine.
My N is small, about 4 successfully made the transition from Methadone to Suboxone and none of them had PW, it was getting their tolerance down enough to be covered by the Buprenorphine that has been the biggest problem. Since I cannot manage the Methadone taper I generally don't see people back after telling them they need to get down to 30 mg a day. (that is done by phone, they don't get charged).


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PostPosted: Sun Feb 12, 2017 8:01 pm 
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Yes, I don't see this statement, pulled out of an ASAM guide, to be a game changer at all. I was just surprised at the information and the fact that I've never seen it before. I didn't know that there was any official body that said that naloxone might contribute to PW in those switching from methadone.

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PostPosted: Sun Feb 12, 2017 11:02 pm 
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I transitioned twice from methadone, first time suboxone, second time buprenorphine. Had pws both times, same severity, same time frame to adjust. I was told it is the bupe itself that causes it?

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PostPosted: Tue Feb 14, 2017 12:24 am 
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I agree with doc2 and the general consensus. The use of plain buprenorphine vs. Suboxone for induction has been a topic of discussion since the start of buprenorpine treatment in the US, in 2003. I get mixed up now about the issue... if I remember correctly, only buprenorphine had the FDA indication for 'induction', even though most doctors did inductions with the combination product (i.e. bupe/naloxone).

My impression has always been that naloxone plays NO role in precipitated withdrawal, even when changing from methadone. My impression comes from buprenorphine having a much higher affinity at the mu receptor than naloxone, and the very small amount of naloxone (3% of the dose) absorbed through the mucosa (the lining of the mouth).

This is going to sound a bit nasty.... but I've lost confidence in the opinions from the addiction agencies and societies. I went to a couple buprenorphine 'summits' over the years, where experts from NIH and SAMHSA meet to discuss buprenorphine treatment.... I never had any 'clout' at those types of meetings as I'm not good at doctor 'politics'. But the leaders of the break-out groups would be the professors from Columbia or Georgetown or another East Coast university, and I would hear comments from them, as recently as 2010, such as 'I've started over 30 people on Suboxone'. My impression was that many of the experts were up on the studies, especially those related to demographics and social policies, but they had little clinical experience with patients.

I'm sure there are exceptions-- but there is only so much time in a day. It takes very little time to crank out a blog post, but it takes a great deal of time to crank out journal publications. I have a few of them-- got to pub med and search junig and you'll see them-- but each one took months, and a secretary, to get the right formatting, review the editors' comments, review the proofs, etc. For that reason there is a divide between the academics and the clinicians-- and the academics write the guidelines for medical societies, for the most part.

That divide is why I feel like an underdog when I write my impressions that run counter to the things I read from ASAM or SAMHSA. For example, do we REALLY have a huge diversion problem with buprenorphine? Or is my impression accurate-- that buprenorphine is used by addicts to bridge between heroin doses, or used for 'self treatment', largely because of the lack of buprenorphine prescribers?

Or another issue-- is there REALLY such a difference between buprenorphine and the combination product, that plain buprenorphine should be viewed so negatively and even banned by at least one state? Or in reality are they about the same drug? In my experience, I hear patients talk about noting little difference, whether injecting buprenorphine or Suboxone. But the literature makes it sound like plain buprenorphine is 'just like heroin', and Suboxone is much safer.

The biggest issue is in the treatment of surgical pain. The SAMHSA people mostly write that people should 'just hold their buprenorphine for a week' before surgery. I find that suggestion to be ludicrous, as patients either won't follow the instruction, or if they do they will come to surgery weakened and dehydrated. It is so much easier to just continue the buprenorphine, and treat pain with a higher dose of opioid agonist!

My point after all of this ranting is that many of the things put out in consensus papers seem at odds with what I see in patients. As for this specific situation, I think that the buprenorphine is much more likely to cause PW than the naloxone, especially since naloxone only lasts for about 20-30 minutes after it is absorbed. So beyond the affinity issue, any naloxone causing problems just isn't going to be around long enough to matter!

While I'm on the topic of 'fake news', here is one last thing that I'll probably regret writing... have people heard of 'NAABT', the 'national alliance of advocates for buprenorphine treatment? You'll see NAABT quoted now and then in articles, as the 'organization's' title sounds like they must be the experts. But why is there no list of members? Why is there no way to join? Why is it that when I've contacted them, there is no doctor who I can communicate with?

I could be wrong... but over the years I've developed the impression that NAABT is sort of like the Wizard of Oz-- this impressive name, with one person behind it who set up a nonprofit in order to take donations and print pamphlets copying what other agencies have said. I'll try to put out a blog post about my experience over the past few weeks, trying to correct the WI Drug Database conversion values for buprenorphine.... they make the mistake of extrapolating the potency of low-dose buprenorphine out in a linear fashion, forgetting about the 'ceiling effect'. If you google buprenorphine potency, you will find at the top of the page a paragraph from NAABT that says that buprenorphine is 40 times more potent than morphine. As I tried to find the source for Wisconsin's conversion data I was sent to Brandeis Univerisity, who then said they get it from the CDC-- and I found that the NAABT description was lifted, word for word, from the CDC description. That would be OK, except the CDC description refers to LOW dose buprenorphine, and NAABT uses that same date to describe HIGH dose buprenorphine, which results in incorrect numbers.

Be careful who you trust on buprenorphine. one last thing-- today I saw a patient who was told she had an allergy to suboxone, after becoming very sick and sedated after several doses. At first I thought she must have had a low tolerance, but she described using high amounts of opioid agonists. But buprenorphine and naloxone allergies are very rare, so I went through her history with an open mind. Turns out she was on naltrexone, and the doc told her to stop the naltrexone for a week before induction. Anyone wanna guess what happened? She likely had 'inverse tolerance'- i.e. extreme sensitivity-- to opioid agonists, caused by the naltrexone. So when she induced, the buprenorphine was WAY too strong, and almost killed her. A couple Australian studies have shown increased rate of overdose and death in patients who relapse after naltrexone.

That's what makes this field so interesting-- we have a medication that SHOULD be changing the world, yet most doctors never take the time to learn anything about it. Leaves those of us who work in the field with all sorts of things to write about!!


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PostPosted: Tue Feb 14, 2017 1:20 am 
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Well, it would make sense for me to delete my original post and this thread, except that Dr. Junig has written so eloquently to caution us from making too much of opinions from publications like the ASAM National Practice Guidelines For the Use of Medications In the Treatment of Opioid Use Disorders. I have certainly seen incorrect statements in these types of publications, which often seem as if they are written for people who don't need to know how buprenorphine should be utilized in real life. I can certainly understand Dr. Junig's lost confidence in the organizations that produce them. It's like the difference between those that plan a battle from afar and those that fight the battle in the trenches.

I'll try to make sure that my sources from now on only include actual research studies. ;)

Amy

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PostPosted: Tue Feb 14, 2017 10:36 am 
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I know one person I trust for Buprenorphine information, and that is you Dr J....
It is frustrating to see the "pros" seemingly getting much of it wroug ..


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PostPosted: Tue Feb 14, 2017 1:52 pm 
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Just my own little sliver of personal experience....I've seen four doctors so far who've given me prescriptions...2 of which I never filled... and three of them gave me incorrect information.

The clinic doc who I saw for a few months before my current physician, did not understand what I was talking about when I brought up long half life as it relates to delayed WD symptoms.. My current doctor who calls himself an addiction psychiatrist is of the belief that those on high doses of bupe....8 mg or above....should be getting substantial pain relief.

Of course these guys are supposed to be educated in this area. Addiction psychiatrists I've been given to understand have to undergo substantial training in order to qualify. It's really pretty shocking.

From what I've read here and elsewhere, my experience is not that atypical. So perhaps it's not just the academics who aren't as up things as they should be.


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PostPosted: Tue Feb 14, 2017 2:53 pm 
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My current doctor who calls himself an addiction psychiatrist is of the belief that those on high doses of bupe....8 mg or above....should be getting substantial pain relief.

Respectfully Godfrey, I do agree with your doctor. I have several people taking 16 mg a day in split doses that gives them some relief and function at a much higher level than when they were taking full agonists. Could they do better on lower doses, perhaps, most are working towards that. I have one lady that has gone from 4 tabs ( later strips) a day and is now taking 6 mg a day. Same pain relief, feels better at the lower dose as well.
What should happen and does happen often don't match in the clinical world. Expectations, 'placebo' effect are real phenomenon that we deal with.

Just looked at my induction list, almost 200 now so more than some of the 'experts' Dr. J was commenting on. "cool', I thought.

Some of the addiction psychiatrists, if they trained before 2002 would have no training in BUP. Yet, by virtue of their training certificate they do not even have to take the 8 hour course other doctors do. Hopefully they did their diligence with keeping up with the literature. "Nudge, nudge, wink wink, say no more, say no more."
PA's and NP's are just around the corner, they are in the process of working through the 24 hour course so should be online soon.


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PostPosted: Tue Feb 14, 2017 4:14 pm 
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"Expectations, 'placebo' effect are real phenomenon that we deal with."


Hey Doc,

Well here we go again..in a good way. Perhaps I misunderstood Dr. Junig when he recently chimed in. He did discuss placebo effect and complex mind body interactions (my words not his) I think he was saying, to account for this. (I just want to add by way of edit that I reread Dr. Junig's response yesterday....and I see he went to great lengths to explain how pain relief might work)

I of course don't want to argue with an expert. I'm merely asking questions.

For what it's worth, I get no pain relief at all. Not at 32 mg'.s and now not at 8. Nor anything in between. If some patients report pain relief that of course is great for them. But is it really realistic to expect that?
Should I be getting pain relief? Perhaps another way of asking this is, do most people? My understanding is most people do not. Is that just plain inaccurate?.

Perhaps I should start dividing my daily 8 mg, into quarters?

I suffer every day. Sometimes all day, My kingdom for a little pain relief.

Are doctors then actually correct when they tell patients...dentists for example....that they don't need to worry about pain because they're on high dose buprenorphine maintenance?


Last edited by godfrey on Tue Feb 14, 2017 4:47 pm, edited 3 times in total.

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PostPosted: Tue Feb 14, 2017 4:17 pm 
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This is exactly what I was trying to clarify the other day! I don't think that, just because someone is on 16 mg or higher, that they can't split their dose to receive the same analgesic effect as people on lower doses. I had thought that the ceiling limit mitigated the addiction symptoms, not the analgesic effect. I have also known people who have gotten pain relief on higher doses, but they have to split the dose into 4 parts.

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PostPosted: Tue Feb 14, 2017 4:41 pm 
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"I have also known people who have gotten pain relief on higher doses, but they have to split the dose into 4 parts."

I'll certainly give this a try, Amy. Nothing at all to lose.

I reread Dr. Junig's response and I see that he's leaving the issue much more open than I'd first realized.


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PostPosted: Tue Feb 14, 2017 7:12 pm 
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I so feel for you, Godfrey, because I also have pain, but not 24/7. Whether it works for you might depend on the type of pain you feel. I know, for example, that nerve pain is often helped by Lyrica and Neurontin. I just don't know. I thought I knew more before this subject came up. I guess we just have to recognize that at least some of our info is anecdotal and may not be able to be confirmed except by individual experience. I am fortunate that buprenorphine did a decent job on my recent dental pain, along with NSAIDS.

I hope that trying it yields the best possible results for you.

Amy

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PostPosted: Tue Feb 14, 2017 7:34 pm 
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Quote:
Are doctors then actually correct when they tell patients...dentists for example....that they don't need to worry about pain because they're on high dose buprenorphine maintenance?


No, they are flat out wrong. If you have an acute pain generator, such as a fractured bone or abdominal surgery the high dose buprenorphine will not cover it. It takes a lot of pain medication to override the buprenorphine and get adequate or even marginal relief.
Dental procedures can sometimes be managed with measures such as nerve blocks, NSAIDS, Tylenol and ice. That said, being on Buprenorphine is not going to cover new, acute pain on its own.


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PostPosted: Tue Feb 14, 2017 9:25 pm 
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Yes, I understand acute post surgical pain is not the same as chronic pain. It was not a very good question, and was perhaps even a little disingenuous. I'm sorry for that. I almost deleted it but then thought, well perhaps for things like tooth extractions, it might be helpful. And for Amy that appears to be the case. :D

Amy wrote: "I thought I knew more before this subject came up. I guess we just have to recognize that at least some of our info is anecdotal and may not be able to be confirmed except by individual experience. I am fortunate that buprenorphine did a decent job on my recent dental pain, along with NSAIDS."

Thanks for that Amy. I appreciate it.

And I can say exactly the same thing, that I thought I knew more than I really do. But that's common for me :D


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PostPosted: Tue Feb 14, 2017 11:14 pm 
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I had a sort of dull dental pain with spurts of acute pain.

Helped the dull more than the acute for sure.

Amy

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