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PostPosted: Sun Jan 17, 2016 8:02 pm 
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I've been catching up on the status of Probuphine the last few days. While it's not FDA approved just yet, it will be very interesting to see if the FDA has a change of tune after its last rejection back in 2012-2013. Given their decision nearly crushed Titan back in the day, I'd imagine many are watching the FDA nervously now.

Probuphine is pretty much old news now. But what's interesting is there's two new products being pushed now by Braeburn Pharmaceuticals in conjunction with these guys Camarus which they assigned the memorable names of CAM2038 q1w and CAM2038 q4w. They're essentially a depot subcutaneous injection of buprenorphine, one lasting 1 week, the other lasting 4 weeks. This is similar to some depot psychiatric medications, where patients come in once a month to their doctors appointment and receive the injection.

Like the implants, these injections are set-and-forget. Once it's in, you don't have to worry about it. No need to let some film dissolve under your tongue each day. And one of the big benefits of these injections over the implant is that, at least in theory, they allow for a much wider variance in dose.

You may laugh, but I have a feeling that one day nearly everyone on buprenorphine for opioid dependence will be on some kind of depot or implant. Legislators, even the DEA will jump at the opportunity to eradicate diversion, and prevent people from skipping doses in order to continue to use.

What will be interesting is whether people could end up court-ordered to receive depot buprenorphine in the same way people who are non-compliant on their psych medications can be court ordered to receive depot medication. Instead of sending people to jail for crimes committed to feed their opioid-addiction, they could be ordered to receive monthly injections. Many years back in my country the "abstinence lobby" (a group of Christians heavily against the use of methadone and Suboxone) pushed the government to make naltrexone implants compulsory for all heroin addicts. The medical world pushed back because of naltrexone's poor record in treating heroin addiction. I would imagine it wouldn't be that far removed for a conservative lobby to push for a similar approach with depot buprenorphine.

Anyway, just a thought.


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PostPosted: Mon Jan 18, 2016 7:01 pm 
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Very interesting topic TJ. I'm a member of a suboxone facebook group and people were talking about whether the FDA would approve it this time. It seems like a no brainer, as long as there is some emergency protocol to give implant patients pain relief if they have some sort of accident. At the same time, people might not like it that they no longer have control over that daily dose. It also wouldn't be appropriate for people who are tapering. The super controlling doctors out there would love it. And you're correct. I think the lawmakers here would love the idea.

Yes, I do think that courts might start to mandate that addicts that reoffend be put on an implant. It certainly wouldn't be the worst thing in the world, but it does tend to infringe on civil liberties. And if that was all that was offered there wouldn't be diversion of bupe. I don't know. It seems like it would be a very good med for those who keep relapsing.

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PostPosted: Tue Jan 19, 2016 12:50 am 
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I just read an article yesterday from NPR about the prospects of bupe implants. I have been looking for it the past few minutes, but I think I tossed the email that included the link. I agree with TeeJay that bupe injectables will gain traction for the reasons he mentioned, but I don't agree with the thought that 'conservatives' are likely to be the ones pushing it. Most conservatives I know (me included) are much more interested in keeping the government out of healthcare decisions-- and I doubt they will have much interest in mandating addiction treatment. On the other hand, I'm constantly battling agencies typically made up of pro-government types--- the child protective services folks, county social workers, and probation agencies-- who mandate aggressive monitoring and abstinence-based treatment programs.

Whether the arguments come from the right or left, I'll continue to advocate for healthcare decisions to be made by doctors, and (hopefully some day, like in the old days) only by doctors. Hopefully politicians will eventually realize it's much more complicated than 'giving the green pill instead of the red pill'... an idea that one particular idiot made a while back...


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PostPosted: Thu Jan 21, 2016 12:35 am 
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Hello everybody :)

I've been selected to take place in this aforementioned study. I'm extremely nervous,yet,a little excited at the same time to have this opportunity. As the poster with the cute Mario brothers avatar stated, there will be a weekly and a monthly Long-Acting Subcutaneous Injection Depot of Buprenorphine, called (CAM2038) - injected into the buttox. I have to go my wife is telling me Dinner is ready, and I do not wish to keep her waiting. The second week of February is when the Research Study begins. I will keep you all informed, my study Dr.is Kent Steven Hoffman DO, I just happened to join his practice 16 months ago. He is wonderful, and there are 160 people participating in this study in the United States (where it is in Phase 3 Trials) . Same will be in Japan, and others in Eastern Europe. I'm still in a bit of shock that it's actually going to happen....well, if I pass the initial phase. I hope to be part of history, in the evolution of Buprenorphine treatment. Stay tuned!


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PostPosted: Thu Jan 21, 2016 8:12 pm 
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Thanks for that Steppenwolf. Exciting times.

Please stick around and let us know your experience of the trial. I'm very interested to know how the depot formulations work out.

Is it a placebo controlled, randomised trial? ie is there a possibility you will be receiving a placebo? I doubt they would do that. Ideally they'd be comparing the effectiveness of the depot vs sublingual, but you never know.


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PostPosted: Sun Jan 24, 2016 8:33 pm 
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TeeJay - I wish I could answer your question, but I don't know. The consent form I signed had 18 pages worth of information about the study, and what would be expected from me. I must've read that from, line by line, three times. Nothing was mentioned about a placebo group; but, then, maybe they don't want to give any hints away?? Who knows?? :lol:

There will be different groups, 4 total, I believe.

Group 1 - will consist of people coming in who have never taken Bupenorphine before, they will have to come into the Dr. Office in a state of withdrawal. These groups will either receive a week long injection, or a month long injection. Yet,along with the injection, they will be taking their induction dose of Sublingual film like normal.

Group 2 - which I fall under. Will consist of people who have been taking Buprenorphine, sublingually, for at least 6 months. Now that I really think about it;shit,I've been taking Buprenorphine - in every form available (Started with Suboxone - and now stable on 12mg Zubsolv) Getting back to the point. Just as Group 1; Group 2 will be broken up into people who receive the injection either weekly or monthly.

Again, they didn't mention anything about a Placebo. But this is Phase 3 of a very long and costly study. The data collected after this 12-month study, along with the two before it, which were 6months for some reason, will be what, I believe,paves the way whether or not this new medication is FDA approved.

The only way I can think of the Dr. giving a placebo, would be to either make the (sublingual suboxone) the sugar film, or the( injection) the sugar shot. Because all of us, group 1 and group 2 will still be taking our regular dose of suboxone while receiving the injection. That's one of the many interesting things about this. Group one will be inducted, and stabilized on a dose, and the veterans will continue taking the dose we are stable on, all the while, both groups will be getting the shot. :roll: We shall see in a few weeks, as I promised, I will keep a running, 1year journal of the experience.


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PostPosted: Thu Feb 18, 2016 12:59 pm 
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Received CAM2038 injection, February 16th,8:30AM.
I was worried for about 3 hours, due to feeling a rush of
energy,that,for me, was too intense. That feeling leveled
off and I am now feeling........normal. It's weird,though,
I'm having difficulty getting used to feeling this way without
the routine of taking a sublingual pill (I used to take Zubsolv 3 times a day).

I keep expecting to go into agonizing withdrawal at any moment, but that's not
what's happening. The whole process, so far, is fascinating. I'm still
holding on, expecting something bad to happen, but everything is okay.

Other than the period immediately after the injection, the 3 hour period, did
I feel different. It's only been three days, I still have a long time until the next
injection.

If this works, and I feel fine for a month, get another injection and feel fine for a month...repeat...repeat...repeat.
LOL - the worst part of the whole experiment will be month 12, the day I receive my final
injection.

Take care,
out there.


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PostPosted: Thu Feb 18, 2016 8:03 pm 
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Thanks Steppenwolf for keeping us posted.

You make a good point about the psychological need to take your dose of Suboxone. Despite people claiming Sub isn't addictive and it's only dependence forming, I do feel there is still addictive reinforcement when we take our dose once a day. Of course this would be heightened if we took our dose multiple times a day. And minimised significantly if we only dose once a month, in the case of your depot.

Stick around because, as far as I know, you're the first person to ever get depot buprenorphine that has graced this forum.

I'm interested to know how the injection holds its effect over the month, and how they decide what dose of depot injection you receive. Is it based on your previous Suboxone dose? Do you think that maybe your blood levels of buprenorphine are actually higher now you've had your depot?


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PostPosted: Thu Feb 18, 2016 10:37 pm 
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No problem, TeeJay :) I will be happy to answer questions about the process. Known as (CAM2038)
I guess the name comes from the review board behind the study - Copernicus Group, mixed with the study sponsor (Braeburn Pharmaceuticals.) :lol: that is complete guesswork on my behalf, who the hell really knows. The Dr's Office I go to writes a $45.00 dollar check from their own account, so no hints there.

I can tell you what the procedure consists off. It's like any other Suboxone visit,you give them a little pee-pee. You are weighed, and have your blood pressure taken. Then, the oddest looking needles I've ever seen in my life are brought out, and you're asked to either stand or lie down. I felt at ease lying down, and,that's what I did. After that, you're asked to pull your pants down, not far, at all. Just low enough to where to top of your butt-crack is. The study director finds your "special vial" to inject. Once ready, the director pinches a little piece of butt-cheek, inserts the needle (which you DO NOT feel) and injects the subcutaneous depot.

Forgive me if I'm repeating myself, but I am part of the Month long injection depot. And that is where the only modicum of pain is felt, the feeling from the fluid in the needle. It stings, very similar to a tetanus shot, but not for long 30-34 seconds at most, and there is a bruising sensation at the injection point. I still feel it today :|

Take care,
all of you!

And thanks for showing interest TeeJay. That's the second reason I wanted to do this. To be a part of the evolution,that will one day ease the agony we all know to well.


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PostPosted: Fri Feb 19, 2016 7:35 pm 
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Thanks Steppenwolf.

Something that interests me is how you'll feel over time. How long does the study go for?

When I take sublingual Suboxone, I metabolise it pretty quickly. ie I wake up with mild withdrawal symptoms every morning. Because depot provides a steady stream of buprenorphine into the bloodstream, I'd imagine this would no longer be a problem for me on the depot. But for me, putting up with this mild withdrawal every morning has a positive effect. Because it gives my body a chance to downregulate its opioid receptors each day, I don't feel any desire to gradually increase my dose, as long as I take my Sub at the same time each day at the same dose of 4mg. I hope that makes sense.

But this would not be the case with the depot. So I'm curious if, after a few months on the depot, you start to experience the need to increase your dose. But I understand that you won't be able to tell at this early stage.

Out of curiosity, how did they calculate what dose of depot you required?


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PostPosted: Sat Feb 20, 2016 12:09 am 
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TeeJay wrote:
Thanks Steppenwolf for keeping us posted.

You make a good point about the psychological need to take your dose of Suboxone. Despite people claiming Sub isn't addictive and it's only dependence forming, I do feel there is still addictive reinforcement when we take our dose once a day. Of course this would be heightened if we took our dose multiple times a day. And minimised significantly if we only dose once a month, in the case of your depot.

Stick around because, as far as I know, you're the first person to ever get depot buprenorphine that has graced this forum.

I'm interested to know how the injection holds its effect over the month, and how they decide what dose of depot injection you receive. Is it based on your previous Suboxone dose? Do you think that maybe your blood levels of buprenorphine are actually higher now you've had your depot?


I look at the need for some of us to take a dose every day as part of the disorder that is addiction, not a side effect of bupe. When we get into recovery with bupe the medication takes away the craving and obsession, but it can't take away the need we may feel as addicts to take a pill to feel better. When our brains go through dramatic changes based on addiction, it makes sense that there are still parts of our psyche that need attention and reconditioning.

My opinion, anyway.

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PostPosted: Sat Feb 20, 2016 1:54 pm 
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Yeah I agree Amy. Unfortunately since my addiction started, I look for a quick fix for everything. If I have a cold, I'm looking for something to fix it immediately like I just can't hardly handle it. I just recently started taking a stomach medicine and every morning like clockwork that's what I reach for along with my sub. I'm just trying to say that I'd be this way with anything these days not just suboxone. Something definitely changed in my brain that makes me react this way.

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PostPosted: Sat Feb 20, 2016 9:14 pm 
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Wha'sub, TeeJay. I wanted to answer your question about how they figured out the best dose to give me. Before signing my life away to take place in this subcutaneous research delivery system. I was taking 12mg,split 3 times a day. Like you,I also have a fast metabolism.

The honeymoon period with this experience has been short lived. I woke up today with my heart pounding,and sickly sweats making me feel sticky and clammy. I was cold in warm rooms,hot in cold,confused,anxiety hammering away each second.

I called my Dr. and he told me to come into the clinic early Monday morning so I could receive an 8mg booster shot. I'm allowed up to 32mg in booster shots each month ( I think) I need to read the
documentation that explains the finer details of everything again.

I have 6 zubsolv tablets,and asked if I could take any of those until Monday's booster. He called the study sponsors, and they gave him the thumbs-up. I,nor he, knew the answer to that until early this morning. The answer being if I could take a sublingual medication from the previous month............Soooo
Half a zubsolv has me feeling better.

A year is a long time to be a Guinea Pig for Copernicus Group and Braeburn Pharmaceuticals. I truly hope things level out and don't have to go and get booster shots every week. It was a very unpleasant morning. If I didn't have exams to study for,then,things would be different. My mind was blank until the zubsolv eased things up.

My doctor said he gave me a preparation that was supposed to be equal to 12mg,to answer your question TeeJay. He was extremely kind this morning, he returned my call within 10minutes, and called me back again when he found out if it was okay to take the Zubsolv. It's a learning process, like everything.

I will let you know how the booster shot works out in a few days.

Take care, everyone.


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PostPosted: Sun Feb 21, 2016 7:30 pm 
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I'm sorry to hear of your experience. It sounds like the implant isn't providing a consistent dosage. Maybe they've still got some issues to iron out?

I hope it works out with the booster.


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PostPosted: Mon Feb 22, 2016 5:14 pm 
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TeeJay wrote:
I'm sorry to hear of your experience. It sounds like the implant isn't providing a consistent dosage. Maybe they've still got some issues to iron out?

I hope it works out with the booster.

Hello my mushroom headed friend :) (Your avatar,that's from Mario Brothers,right?)

Well, I set my alarm clock to wake me @ 5:20AM. Of course, as always when I can't sleep due to some sort of stressor, I opened my blurry eyes and, slowly,as my vision cleared. I saw 5:12AM......Anyway,I'll skip all the fluff and get to the point.

After some brief questions by the research lead, I saw my Dr. answered more questions. After that, he instructed the research lead on the dose to give me in my booster.

I feel much better. It's just hard to study because I'm so sleepy feeling.

I was assured this would help me until my next scheduled visit. Which is about 3 weeks from now.......I sure hope so!

take care,
everyone


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PostPosted: Mon Feb 22, 2016 6:59 pm 
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Hey Steppenwolf,

I am in awe of you participating in this study and also for posting on your experiences here. Most interesting and many many thanks. Best, Pelican


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PostPosted: Mon Feb 22, 2016 8:41 pm 
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So, just a slightly educated guess here. If I'm reading this correctly you started the depot calculated to 8 mg day. You felt "normal" for the first three days but then on the third day you felt withdrawals. If I have that all correct it would appear the depot dose is really less than what you were on. You had enough in your system to carry you the first days - just like someone who drops or reduces their dose. These people often feel good for a few days then withdrawals hit. It would appear that's what happened to you. If the booster is also an implant I'm betting you will do fine. You are but one subject but if the same thing happens to others they may have to adjust how they caculate subling to depot


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PostPosted: Mon Feb 22, 2016 9:19 pm 
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Pelican wrote:
Hey Steppenwolf,

I am in awe of you participating in this study and also for posting on your experiences here. Most interesting and many many thanks. Best, Pelican


Hey,thanks! It truly makes me feel good inside and warms my heart, to know people are showing some
interest. The only reason I'm doing....well(and there's a long way to go), there are a few. But the main reason, is that my Study Dr. happens to be the lead research Dr. He has shown me nothing but absolute kindness since that first day I saw him back in March 2014, for my induction.

I was about to do something horrible, but I stopped myself. By horrible I mean finding my Wife's safe box, and stealing 300 dollars she made from her hair convention, where she sells beautiful,handmade,little works of art for your hair. I found the box, still unpacked,from her trip to DragonCon, where she made a nice chunk of lute. So I took her safe,my reptilian brain only caring to fix the suffering I was feeling. Made a deal for 7grams and began the drive to pick it up......on the way their I started crying, thinking,what a monster I was. To do this to her again, after all these years of broken promises. I mean,I was sobbing,snot dripping from my nose eyes swollen from the tears. I returned home, ran upstairs, to find She was still asleep. I sat in the bed and started crying again,telling her what I did,and how I had relapsed. Since it didn't seem like I could quit on my own, I found my Dr. Who is so so wonderful. My wife drove me to induction (I couldn't) and he had us watch a video together, it was very well produced and on the way home she said she learned a lot,that I couldn't explain to her,and it explained my behavior eerily perfect.


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PostPosted: Mon Feb 22, 2016 9:33 pm 
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donh wrote:
So, just a slightly educated guess here. If I'm reading this correctly you started the depot calculated to 8 mg day. You felt "normal" for the first three days but then on the third day you felt withdrawals. If I have that all correct it would appear the depot dose is really less than what you were on. You had enough in your system to carry you the first days - just like someone who drops or reduces their dose. These people often feel good for a few days then withdrawals hit. It would appear that's what happened to you. If the booster is also an implant I'm betting you will do fine. You are but one subject but if the same thing happens to others they may have to adjust how they caculate subling to depot

Hi Donh, lol, I apologize but I have to make this letter quick.
I started the depot stabilized at 12mg coming down from 16mg. The boosters are 8mg depots, and on my next visit in march, I was told by my doctor that I would receive the booster depot adjusted to the dose of my booster received today. He confided in me that I was started at 16mg, being the first month of the research project would have dropped me to 12, which I was ready to do. He has been a participating Dr in Phase 3 trials for Bunavai, Zubsolv, and now this CAM2038 - monthly injection. Long story short, he said in all the trials there always had to be adjustments that were higher than originally expected. That is why when he started me at the 16mg monthly CAM, he hoped it would hold. I will receive 24mg next visit, and see where that takes me.

I apologize for the quick tone of this response, but I have a lot of exam work to do.

take care everyone,
always


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PostPosted: Mon Feb 22, 2016 10:14 pm 
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Dude!!

You are amazing!!

I painfully know that reptilian brain! And wish my using thoughts had not ended there and instead went up to my thinking cortex, assuming that would have helped...

Super that you know your priorities and left us to study. Good!!

YOU are doing important and remarkable work -- helping yourself and others far longer than you will ever know by doing and posting. I cannot say I could/would have the same strength and courage and done the same. I remain in awe and hold much gratitude to you for all you are doing. I am also grateful Tee Jay creating this post because it served as an anchor for which YOU responded. Well done. Thanks to you both - really, Best, P


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