Today Nycole Thomas, director of patient outreach for Northpoint Recovery joins us. Nycole talks to us about medically assisted therapy through the use of Naltrexone and extended release Naltrexone. We cover the advantages, disadvantages, effects, side effects and brain chemistry.
"In tandem, that's what it is. It's not magic. It's not get your [Naltrexone] injection, and magically you are cured of a debilitating disease. It's in tandem with individual sessions, family sessions, community support, 12 Steps, any variation of that... The two in tandem buys time, and that's what we need. Time. We need time for healing."
- Michael Biggins, M.Ed., Addiction Specialist
Earlier this year, a patent (U.S. Patent No.: 9,861,628, to be exact) was filed for a new drug to be used in medically-assisted treatments, primarily, for the purpose of treating opioid addiction in patients. To be exact again, the patent states: "treating pain in a human or animal or for drug substitution therapy in drug-dependent human subjects."
Therefore, more specifically, "human subjects" who have become addicted to medically-prescribed opioids, such as OxyContin. Not surprising, you may think, considering the epidemic-level opioid crisis currently being faced in the United States.
One of those who filed the patent is a certain Mr. Sackler; Richard S., of Greenwich, CT, who, if you have not heard of him, is the former president and chairman, now just a director, of Purdue Pharma, the company that actually produces OxyContin, and currently the subject of yet another lawsuit, this time brought by Colorado's attorney general, Cynthia H. Coffman, for Purdue's "significant role in causing the opioid epidemic."
Just consider that for the moment.
Here at Northpoint Recovery, we use a different drug entirely for our medically-assisted treatment of opioid addiction, known as Naltrexone. In No Way But North's third podcast: Nycole's M.A.T. (Medically-Assisted Treatment), our first clinically-focused episode, we speak to Nycole Thomas, BSN, RN, our Director of Patient Services, about Naltrexone, Northpoint Recovery's chosen opioid addiction drug.
We talk to Nycole about:
The podcast is hosted by Northpoint Recovery´s Cooper Lyons, assisted by Michael Biggins, M.Ed., addiction specialist.
Director of Patient Services at Northpoint Recovery
Nycole is a registered nurse with a passion for providing unbiased quality care to underserved populations within the community. She is also ACLS-certified in emergency care in order to provide a medically safe detox. Nycole earned her Bachelor of Science degree from Boise State University, and is a member of Sigma Theta Tau International Honor Society of Nursing.
Here's why Nycole considers the extended release form of Naltrexone, which is administered by injection every 30 days, and carries the brand name Vivitrol, as the best one out there for medically-assisting recovering addicts during their post-detox, continued treatment with us:
"We use a lot of [extended release] Naltrexone at Northpoint, at Ashwood, at Evergreen, at all of our facilities, because we have found it is a medication that works really, really well when people [recovering addicts] are doing all the other things like going to outpatients, therapies, counseling services, working the 12 Steps, they have a sponsor. When all those things are in place, this is a medication that can help in addition to that.
The idea behind it is that it cuts down on the cravings significantly and it prevents opioid relapse. If somebody has Naltrexone in their system and were to use any kind of opiates, it blocks that from working."
Naltrexone is a prescription, full opioid antagonist drug, whose primary use is to block the effects of heroin and other opioid drugs, such as medically-prescribed opioids. Naltrexone is used in pharmacotherapy (also known as M.A.T.), in which a drug of dependence is replaced with a prescribed drug. Its use helps to stabilise a recovering addict's life and to reduce the harm and effect of possible drug use. Furthermore, it can also be prescribed to people with alcohol dependence.
Opioid antagonists such as Naltrexone act in the following way:
The opioid system controls pain, reward and addictive behaviors. Because opioid agonists, such as codeine, fentanyl, heroin, hydrocodone, methadone, morphine, and oxycodone, eg. OxyContin, bind tightly to opioid receptors in the brain and then undergo significant changes to produce a maximal effect, by introducing an full opioid antagonist, eg. Naltrexone, into the body's system, a protective blockade is produced around the receptors themselves. This results in the agonist failing to create their tight bind on the receptor, thus stopping any effect, ie. "high," from occurring in the first place.
As Nycole explains, "So what it does is sits on the neuro-opioid receptors and acts as a literal blockade, so any time opiates are introduced into the system, they have nowhere to make that connection that releases an excess amount of dopamine, so you don't get that high that you feel. When that block is in place, it reduces the cravings, but if someone were to go the next step and introduce opiates into their system, they are not going to do anything. It's kind of that extra step that someone that is in early recovery needs. It's like, "What's the point? If I did relapse, there is no way I'm going to get high."
At Northpoint Recovery, we use extended release Naltrexone, which carries the brand name Vivitrol, and is designed to be used to treat both alcohol and opioid use disorder. It is also useful to both prevent relapse after a successful detox from other opioids, and to be used as an alternative to Suboxone and Methadone, which we'll discuss later.
Naltrexone is actually available in 2 distinct forms - a daily tablet or a higher dose injection administered every month:
Important: Patients receiving Naltrexone, either in tablet form or by injection, need to have been opioid-free for a minimum of one week to 10 days. Here at Northpoint Recovery, this is checked through urine analysis.
In summary, extended release Naltrexone (Vivitrol) is:
As with all medications, there are patients who experience side effects with Naltrexone, although these are minor, temporary and stop once the body has become used to them. For some, however, there can be the major side effect of liver damage, the risk of which will be ascertained by blood analysis prior to treatment beginning and ongoing analysis during treatment.
Naltrexone's minor side effects are considered to be:
With regard to the liver, the symptoms of liver damage display as follows:
Important: Naltrexone is a medication for alcohol and opioid recovery, and should not be used if either substance is being used. By doing so, you are risking serious injury, coma, or even death.
As Nycole explains:
"All we start out on is the oral version of Naltrexone just to make sure you tolerate it well. Obviously, we want to make sure, to give it a try first. I have seen a little bit more side effects on the oral version, but really no side effects on the extended release, which is really great. With the oral version, I have seen people get tired and maybe have a little stomach ache. The great news about that is it never lasts more than two days. Even if you feel something mild, it will pass.
The great news is, with Vivitrol, I haven't seen any side effects. No side effects at all. If you can get over, maybe, a sore behind for a couple of days, that's really the worst of it. It doesn't interact with other medications that you are already taking. You don't have to worry about any funky interactions."
Recovery from any addiction is a difficult and challenging process, and we at Northpoint Recovery understand that 100%. Anyone going through recovery needs help with the most common factor behind a possible relapse - cravings, both physical and psychological. As Nycole puts it in the podcast:
"The idea behind it is that while you are focusing on those other things in recovery, because recovery is hard, what this does is that it takes all the noise out of the craving beast, so you really can hone down and focus in on what you should be doing without having that external yelling, "Get high! Get high! Get high!" That is gone. We use this short-term. It's not something you are on forever, so I would say 9 to 12 months is usually how long you are on this extended release Naltrexone."
Apart from constantly monitoring the effectiveness of extended release Naltrexone across our treatment centers, our opinion about this medication is obviously backed by extensive third-party medical study.
For example, Nycole describes an extensive Russian medical study that was published in 2011: "Injectable extended-release Naltrexone for opioid dependence: a double-blind, placebo-controlled, multicenter, randomised trial," by Prof. Evgeny Krupitsky, MD and Prof. Edward V Nunes, MD.
The results, as Nycole reports, were outstanding:
"It is a really, really well-studied medication. We've got a lot of different types of studies out there that show it's a really great treatment and form of therapy. I have a couple now that I have pulled up on my screen. We've got this one study here, and it would be helpful to show people this graph, but you'll just have to listen for now. 6-month, double blind, placebo-controlled, randomized, a really good clinical study. What they did is that they put people into treatment, and they offered half the participants a placebo and the other half got the actual Vivitrol medication. So, coming out of treatment, they had 35% that were staying clean with the placebo, as compared to 90% of people that had nothing different except that Vivitrol was added."
These are the study's results that Nycole refers to:
"We want people to be restored to life, and life is out there - living, and not hunkered down, weathering every craving storm."
- Michael Biggins, M.Ed., Addiction Specialist
"The other study [Treatment Retention] looked at days of sobriety after treatment, so the same idea there, so we had a portion with the placebo and a portion with Vivitrol. People that just went through treatment and, like you said, had the same type of after-care, they were able to stay clean for about 96 days after. Because treatment works, right? We know that. But when nothing different was added except for Vivitrol, we had over 168 days of sobriety. And the study was still going when that was happening, so it was over 168 days."
"Another study looked at the amount of "drinking days" throughout the month so people going into treatment were drinking, on average, 16 days of the month. When went through treatment, people with a placebo were drinking less, 7 days out of the month. There was less than 1 drinking day out of the month for those who had started on Vivitrol, so that one showed 90% fewer drinking days, without alcohol.
We've got a lot of the same results with people coming through Northpoint and Ashwood. We have seen some really incredible results with people that have been through treatment multiple times, just been doing the same thing again and again, and just chronically relapsing. Come to treatment this time, with really big amounts of willingness,
"Look, tell me what to do, I've tried everything. It's not working. I will just follow your direction completely."
They get extended release Naltrexone onboard, and they just absolutely thrive, and come back for their injections once a month and absolutely stay clean and sober.
So what they found with all those studies was that people doing outpatient work, working the 12 Steps, everything else they were supposed to do, and had this extended release Naltrexone onboard, they found that there were rapid results. The medication works right away. It doesn't take 4 to 6 weeks for it to build up in your system like antidepressants do. It works as soon as you take it. They found substantial reduction in drinking days, prolonged initial absence, staying abstinent right off the bat, then there's this great data that shows continued abstinence at 6 months and 18 months. All the data showed that when people have the extended release Naltrexone onboard, they do better and they stay sober."
Addiction specialist Mike Biggins, M.Ed., agrees:
"This, in tandem with those resources, people launch quicker. They are not isolating, they are not hiding, they are not fighting every day. They are ingrained in life. That is true recovery. For us, that is restoration. We want people to be restored to life, and life is out there living, and not hunkered down, weathering every craving storm."
Results proved in all studies that Naltrexone for drug and alcohol dependence can lessen the chance of relapse. It is considered a good alternative to common treatment, and works well with counselling and community treatment programs. Rehab is highly effective in itself, but incorporating Naltrexone for recovery of opioid or alcohol dependence is part of the long-term success.
Like Naltrexone, suboxone is also used to treat opioid addiction However, unlike Naltrexone, it contains a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication in itself, and so has the potential for addiction without supervised administration. However, in suboxone, it is combined with Naltrexone, which is, as we know, an opioid antagonist, stopping any feelings of euphoria from developing from the opioid content of the medication.
Suboxone comes with the following warning: This medicine can slow or stop your breathing, and may be habit-forming. Misuse of the medicine can cause addiction, overdose, or death, especially in a child or other person using the medicine without a prescription.
To fairly compare the effectiveness of Vivitrol (extended release Naltrexone) against Suboxone, let's look at a recent study: "Comparative effectiveness of extended-release Naltrexone versus buprenorphine-naloxone for opioid relapse prevention: a multicenter, open-label, randomized controlled trial," whose results were published in November, 2017. This comparative study was funded by the National Institute on Drug Abuse (NIDA), and carried out by New York University's School of Medicine professors, Dr. John Rotrosen and Dr. Joshua Lee.
During the six-month study 4% fewer patients relapsed when given Vivitrol, compared to those given Suboxone, 52% versus 56%. The lead investigator of the U.S. study, Dr. Rotrosen, says, "The main finding in my view is the relatively equivalent safety and effectiveness of these two medications... This gives patients the freedom to choose a treatment approach that best suits their lifestyle, goals and wishes."
It should also be noted that buprenorphine, an opioid in itself, is the active ingredient of the recently-patented drug that this article mentioned in its introduction.
One of the primary reasons extended release Naltrexone (by injection) is used here at Northpoint and is more preferable than the daily dose tablet is compliance. As Nycole states:
"Time and time again, people have said, "I've tried the oral version and I know myself. I can't be compliant on it." So, they've come out with an extended version of this that is a once-monthly injection. Just once a month, you have to make that decision. It's not a daily thing that you are having to worry about every day.
At Northpoint and Ashwood, the extended release Naltrexone is part of your treatment program, so you have a due date once a month. So every month, you have to go to group and all these other things, and so people at Ashwood just have an obnoxious nurse [meaning herself] saying to them once a month, "Hey you, come over here. It's time for your injection."
Michael Biggins, M.Ed., an addiction specialist and co-presenter of this podcast episode, agrees: "So really, it's the compliance factor. If it's taken daily, we see these great outcomes, but if someone is allowed to monitor that themselves, they may not take it as prescribed."
As Nycole tells us, Vivitrol, the injectable extended release Naltrexone, when not covered through health insurance, is restrictively expensive - between $1,350 - $1,600 for one treatment, depending on the treatment center. However, there is a silver lining for patients who choose Northpoint Recovery:
"The Catch-22, the big catch, is that it's an expensive medication. That's what drug companies get to do. They put this miracle drug out there on the market, no one else is making it, and they get to charge an arm and a leg for it. However, great news! For our patients, in the "Northpoint family," we are able to get this medication covered to patients at no cost, which is amazing.
Rather than billing this through the pharmacy benefit, we bill it through the medical benefit, and because you are already in treatment with us, deductibles get met and this slides right under that deductible. So I would say 99.9% of patients who are wanting this medication get it at absolutely no cost."
Nycole's last contribution to No Way But North's third podcast: Nycole's M.A.T. comes in the form of an analogy - the comparison between a soldier entering the field of battle and an addict beginning their road to recovery:
"A shout-out to Dan Arnold, counselor at Northpoint, for this, but he always uses this example of somebody going into war, and putting on all of this armor, right? That's really what recovery is. It's a war, right up front. He makes this correlation. You've got your helmet, you've your body armor, and you've got your weapon. You're all suited up and ready for battle, and recovery is the same way. You have all these tools, and wouldn't it be crazy if I was giving you this armor for battle, and you said,
"I'll take the breastplate, and maybe the weapon. I don't want any ammo, and no helmet for me, please."
Right?That sounds crazy. It's just that way in recovery too. We have all these tools that we're throwing at people, and we've got professionals telling you this will work and keep you sober, so wouldn't it be crazy for people to say,
"I'm good. I don't want the medication. I don't like taking medication. 12 Steps? No, not for me."
So, it's really the same way in recovery. This is just another tool, and I would say,
"Arm yourself with everything you can, because it really is a battle."