Ionsource
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Pakistan,
2012-12-26 20:50
(4924 d 06:39 ago)

Posting: # 9755
Views: 5,049
 

 Use of Naltrexone prior to Naloxone dosing [Design Issues]

Hello dear members

We want to conduct a BA study for Naloxone solid oral formulation and I just want to know if it is necessary to administer Naltrexone tablet 12hrs prior to Naloxone dosing. What benefit does it have?


Edit: Category changed. [Helmut]
jag009
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NJ,
2013-01-02 19:12
(4917 d 08:17 ago)

(edited on 2013-01-02 22:20)
@ Ionsource
Posting: # 9780
Views: 4,008
 

 Use of Naltrexone prior to Naloxone dosing

Hi,
It is necessary to use naltrexone, an opioid antagonist, to offset the opioid withdraw effect. What dose of Naloxone will you be administering?

John
Ionsource
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Pakistan,
2013-01-04 08:56
(4915 d 18:33 ago)

@ jag009
Posting: # 9783
Views: 3,968
 

 Use of Naltrexone prior to Naloxone dosing

Hi John
Thanks for your reply. The study would be conducted on healthy volunteers with 9 mg oral solution single dose (not solid oral formulation as I was mistaken before). Please give your opinion then.
jag009
★★★

NJ,
2013-01-09 16:41
(4910 d 10:48 ago)

(edited on 2013-01-09 17:26)
@ Ionsource
Posting: # 9804
Views: 3,914
 

 Use of Naltrexone prior to Naloxone dosing

Hi,

I am sorry but I misread your initial question. I am a bit confused. Why do you need to give naltrexone if your study involves naloxone? Are you using healthy subjects who are drug free?

In short both naloxone and naltrexone are opioid antagonists, with the former having a shorter duration of action. Naloxone if given alone will not produce dependence/lead to opiate withdrawal symptoms unless it is used concomitantly with opiates. Naltrexone is given hours before administering opiates to prevent withdraws.

You might want to consult your PI on this.

John
Ionsource
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Pakistan,
2013-01-10 07:15
(4909 d 20:14 ago)

@ jag009
Posting: # 9809
Views: 3,957
 

 Use of Naltrexone prior to Naloxone dosing

Hi John,

In fact my initial question was not that clearly written. Your answer is satisfactory. Since we are only using Naloxone and on drug free volunteers, we don't need to administer Naltrexone since both are receptor antagonists.

I had read the studies which were on Buprenorphine/Naloxone where investigators used Naltrexone since Buprenorphine being partial agonist can induce withdrawal symptoms. But it's not needed here. Have I got it right?

Regards
jag009
★★★

NJ,
2013-01-10 17:41
(4909 d 09:48 ago)

@ Ionsource
Posting: # 9818
Views: 3,880
 

 Use of Naltrexone prior to Naloxone dosing

Hi,

Yes. If I stand correct it's because naloxone is a weaker antagonist therefore if you give it with an opiate then you will still see withdrawal symptoms. That's why you give naltrexone before hand to prevent withdraws since it's a stronger anatagonist (and longer duration of action). Naloxone alone will not cause withdrawal symptoms.

John
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