Thursday, October 21, 2010

New Naltrexone Implant study

I don’t get the opportunity to do a lot of medical research, so I was delighted when Wedgewood Pharmacy asked me to coordinate a study on their new Naltrexone Implants. We had looked at the new implants and they looked beautiful. They were the same diameter as the old ones which meant they would be just as easy to insert, but they were more tightly compressed. The tighter compression meant that they could contain more Naltrexone – in this case 40% more Naltrexone. They were designed to last longer but no one knew if they did last longer and if so, how much longer.

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I am delighted to say that we have just finished the study and we can now report that the implants do last considerably longer than Wedgewood’s previous implants….

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Oral Naltrexone has been approved in the US since 1984, but its usefulness has been very compromised by poor compliance –patients just don’t take their medicine even though they have all of the right intentions. Sustained-release forms of Naltrexone such as implants or other depot formulations have been developed in an attempt to improve adherence. Wedgewood pharmacy were the first to start making Naltrexone implants back around 1998, and they have been compounding top quality products since then. In 2004, a group of researchers in Sweden studied Wedgewood’s implants and reported their results in a medical journal. Their study showed that the 1 gram implant delivered good blood levels for a median time of 55 days but with a range of 30 to 80 days.

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Since then, Wedgewood pharmacy have compounded a 1.4 gram implant that is more tightly compressed and is designed to provide longer lasting therapeutic blood levels of Naltrexone. Our current study was designed to obtain blood levels on patients who received this 1.4 gram implant to determine if it does deliver effective blood levels over a longer duration.

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We identified six patients, who had come to us in order to get a Naltrexone implant to help treat their substance abuse problem. They each agreed to participate in a study of Naltrexone drug levels. The patients had blood drawn 24 hours after the implant was put in. They got another blood level after one month and then every 2 weeks until the implant was gone.

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The results we obtained were very impressive. All of the patients had therapeutic Naltrexone levels at the end of 6 weeks and 50% of the patients had therapeutic levels at the end of 14 weeks. This is considerably better than the previous implants. It means patients don’t have to come back as often to get their next implant and most of them still have good levels for three months.

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We have begun to use these implants in our regular practice and we continue to be very happy with the results. This month we are also meeting with the pharmacists at Wedgewood to see if we can make the implants even better.

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Dr Peter Coleman

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