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PostPosted: Tue May 30, 2017 4:39 am 
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Hi. Bit of a random one, but basically I am considering signing up for a clinical trial that involves being dosed with buprenorphine and narolex. The trial involves receiving 100mg of narolex the day before dosing, which is an IV dose of buprenorphine, and then 50 mg of narolex for the best 3 days. I don't actually know the exact dose of buprenorphine atm (I will find out soon) so I guess this could make my question a bit difficult to answer, but basically I was wondering what level of side effects to expect from this? Obviously I know the narolex is designed to block the action of opoids, but should I still expect significant side effects from buprenorphine, ie nausea, as well as perhaps from the narolex itself? I have never used opoids before, so will have no form of tolerance. Also I understand this drugs are not to be messed around, am I only considering signing up because I am in a slightly desperate situation financially.
Thanks very much.


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PostPosted: Tue May 30, 2017 5:34 am 
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Naloxone? Unsure if you're misspelling a word or if that 'narolox' is something I just never heard of.
I'm thinking the latter...

I wouldn't sign up for anything if I had no tolerance at all to any sort of opioids. Sounds like just asking for trouble...

Seems like the criteria for a clinical would call for currently active opiate tolerance/dependence.

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PostPosted: Tue May 30, 2017 10:01 am 
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Sorry I meant to say nalorex (active ingredient naltrexone, an opioid antagonist)


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PostPosted: Tue May 30, 2017 10:52 am 
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That's interesting.

So they're giving you IV buprenorphine then IV naltrexone?

I got a naltrexone implant while I was on Suboxone once. I was told to not take my Suboxone the day before, then went in and had the procedure. All I can say is I got quite sick. The precipitated withdrawal was quite bad.

Now this isn't SUPPOSED to happen because buprenorphine is meant to have a stronger binding affinity thus naltrexone shouldn't precipitate withdrawal. But it still happened.

Your mileage may vary.

Do you have a link to the trial brief? usually on clinicaltrials.gov


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PostPosted: Tue May 30, 2017 11:14 am 
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tombeen,

Very interesting! will be glad to learn more from you

Are u in the UK or EU or Russia where its called Nalorex? Its Naltrexone here and typically oral tabs or an intramuscular depot, meaning a deposit stays for a week to a month and slowly the med is absorbed in to the blood stream.

You say you are desperate financially. These studies inclusion criteria, usually require you to have a 6 mo history of opioid use disorder. Are you claiming this so you can participate? For $$$? FYI, a subject must demonstrate opiate dependence via urine or COWS or naltrexone challenge to be in the study. Otherwise study outcome is flawed and inaccurate as well as fraught w huge risk to you and trial sponsors if you get dependent.

Are you sure its with buprenorphine? Could u mean bupropion? There are current alcohol dependence trials w bupropion and naltrexone.

I couldn't find a trial w IV buprenorphine w oral or IV naltrexone or any open to NON opioid users still recruiting that seem to match.

Hope to hear more from you. If I understand it, its checking to see if bup is blocked by the naltrexone. Naltrexone is different from naloxone so wondering if its naloxone which is in bup products as a supposed blocker but folks still IV it and naloxone does not seem to be the blocker as expected. Would be good to know if the naloxone in bup products actually does anything.
thanks, best P

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PostPosted: Tue May 30, 2017 4:46 pm 
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Yes I'm in the UK. No it is definitely buprenorphine. The sched is as follows: day 1 - 100 mg nal oral, day 2 iv bupe, 50 nal oral, day 3 50 nal oral, day 4 50 nal oral. Then a 4 day break. Then the sched is exactly the same, but this time bupe is given via sub cutaneous method. So the overall purpose seems to be in comparing the two administration methods
http://www.hra.nhs.uk/news/research-sum ... -subjects/
There is the trial details, I would be just bupe not the granisteron.


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PostPosted: Wed May 31, 2017 10:19 pm 
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Hey tombeen,

Cool! thanks, I totally missed the entire point of the narolex aka naltrexone!! - Of course - You won't feel any of the bup bc the naltrexone will block it. That's why they can use HEALTHY NON opioid dependent volunteers - bc there is NO danger of dependence. Bup's effects will be blocked in all groups. It still gets absorbed tho and that's what they're studying w these new compounds. They're looking to see bup's and the nausea med absorption in healthy people via different routes of administration. Cool.

The same occurred w prior bup product drug developments, naltrexone was used as a blocker in order to use healthy volunteers and yet well study absorption time, peak troughs etc... This is important to learn before trialing on real patients.

Can't see how this would be a risk for you to volunteer...

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PostPosted: Thu Jun 01, 2017 3:00 am 
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It's interesting. Only thing I'd be wary of is, if you're already dependent on buprenorphine, the possibility of precipitated withdrawal when you first take your naltrexone. But the study brief didn't mention anything about naltrexone at all?


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