Nalmefene (Selincro) – Paul’s Personal Experience

Nalmefene (Selincro) was approved for use on the NHS in November 2014.  It was the first medication approved to help lower alcohol consumption levels in those still drinking.

C3 Foundation Europe is pleased to have gained permission to publish the recovery experience of one of the first people (if not, the first) to be prescribed Selincro in the UK.

Paul Shaw - not his real name - is a retired medical professional, and like many in his industry, found himself unable to control, or reduce, his alcohol consumption. 

Dealing with a ‘mild’ dependency on alcohol – a personal experience. - by Paul Shaw.

I am a retired health professional who, for many years, had drifted into the habit of having a drink on a daily basis. It was never enough to cause disruption to my life and I continued to hold down a responsible senior role within the NHS. This continued for many years and as retirement came, my thoughts were I would drink less as I no longer had that stress factor associated with my work life. However, in actual fact I began to enjoy a drink earlier in the evening than previously, which later became late afternoons when I started to have a drink. Most of this occurred at home watching the television and continued until bedtime.

I began to realise that previously, I could maybe have two or three days free of alcohol I was now finding it difficult to have an evening without alcohol. My wife also enjoyed a drink, so this did not help as the temptation was always there. Each morning, I would wake up and think to myself, why did I again drink so much. I never suffered from a hangover or had the feeling of wanting to drink the next morning, and it rarely affected my daily activities. However, I knew that the physical consequences were not good. I had had raised liver blood tests in the past that indicated I was drinking too much and I effectively had cut back then. Now though, I knew I was finding it hard to go without. I knew I was not an alcoholic, based on my past health work experience and all the published definitions. I did though, have some dependency on alcohol, I thought.

By chance, in 2014, I read about a new drug that had undergone trials in Scotland. It was intended for individuals deemed to have a mild dependency on alcohol but not enough to be considered an alcoholic. (That was my interpretation but others may have other thoughts on that). The drug was called Nalmefene and it was being considered by NICE (National Institute for Health and Care Excellence). There was a possibility it would be introduced in England and Wales in 2015 and could be prescribed by a General Practitioner following the criteria.

I continued to look out for more information about this drug and saw that it had been agreed it would be introduced in March 2015 in England and Wales.

I found the following information on the internet (a section of a longer document NICE Guidance TA325)

Nalmefene (also known as Selincro) is recommended as a possible treatment for people with alcohol dependence who:

  • are still drinking more than 7.5 units per day (for men) and more than 5 units per day (for women) 2 weeks after an initial assessment and

  • do not have physical withdrawal symptoms and

  • do not need to either stop drinking straight away or stop drinking completely.

Nalmefene should only be taken if the person is also having ongoing support to change their behaviour and to continue to take their treatment, to help them reduce their alcohol intake.

What does this mean for me?

If you are dependent on alcohol, and your doctor thinks that Nalmefene is the right treatment, you should be able to have the treatment on the NHS. (1)

 

It was an easy decision for me. I made an appointment with my GP at the beginning of March. My GP knew me well both as a patient and professionally and was very supportive. He admitted that he did not have knowledge of the new guidelines but agreed that, in the first instance, we would have further blood tests carried out, and suggested I made a self- referral to Turning Point (A substance abuse organisation).(2).  The intention was that this was the starting point in meeting the criteria stipulated by the NICE guidelines. (This was information I had shared, my GP not having that knowledge of the guidelines at that point.)

I made the self-referral to Turning Point via a phone call. A short discussion with one of their workers determined that from their perspective, I was not dependent on alcohol and not suitable for a referral to their services. Also they were not aware of Nalmefene and in any case could not prescribe drugs. I explained that I was aware that they could not prescribe and that my GP would have to do that. I also suggested that their understanding/definition of ‘mild’ dependency differed from that of the NHS given the NICE guidelines. Work to be done there I felt!  However, the worker was helpful in suggesting another group called NERAF (Northern Engagement into Recovery from Addiction Foundation) (3), an independent charity established to help transform people’s lives by helping them gain recovery from substance misuse.

My telephone call to NERAF was more profitable. Again the lady I spoke to had no knowledge of the new guidelines or the drug Nalmefene. However, it was agreed that I should make an appointment with one of their support workers. This, if memory serves me well, meant a wait of 2-3 weeks. This was the beginning of a long process that involved an initial assessment by the support worker and then a number of visits, having agreed a support plan. My worker was very supportive. I think we both recognised that I was not a typical client and was not presenting with many of the issues that would be expected for such a service. No one in NERAF had heard of Nalmefene or the NICE guidelines but my support worker was very interested and receptive to learning more about this.

A review with my GP confirmed, as expected by me, that my liver results were high. In fact, they were higher than at any time in the past. I had met the NICE criteria at this point, in that I had been receiving support from NERAF, but also I had still not significantly reduced my drinking. My GP though would not prescribe me Nalmefene, however, until he received feedback from NERAF. In the meantime, I also received good counsel from a website called ‘Patient’ and the forums on the site relating to Alcohol matters. It was here I first learned about The Sinclair method(4). The Sinclair Method (TSM) is a treatment for alcohol addiction that uses a technique called pharmacological extinction - the use of an opiate blocker to turn habit-forming behaviours into habit-erasing behaviours. The effect returns a person’s craving for alcohol to its pre-addiction state. I wrote to my GP providing articles about TSM and related reading which I hoped would increase his understanding and willingness to support me with this. After all, it seemed that Nalmefene was a similar drug to Naltrexone that was generally used with TSM.

The process leading to actually being prescribed the drug Nalmefene was a lengthy one. This was in part due to communication breakdown within the GP surgery and the misplacement of a letter from my support worker to the GP (hand-delivered). This was eventually resolved and several weeks after from my first visit to the GP I was prescribed the drug. I collected my prescription and read the literature. I read the possible side effects so that I would be aware of any possible problems associated with the drug. The drug should be taken 2 hours before drinking. The first day I took it I was sitting in the garden. After about half an hour, I began to feel uncomfortable, with nausea and a cold sweat. It was associated with a strange feeling generally. Then I began to get a little worried as I felt what I could only describe as pressure in my chest. Later this subsided but was overtaken by cramping sensations in my abdomen. I had read about the nausea and the possible cramps, however, I really wasn’t feeling too well and there was no way I was contemplating having a drink. The following day I repeated taking the drug and suffered from the same side effects. This was not good and I was slightly concerned that this drug was not going to be suitable for me. I went onto the ‘Patient' website and was reassured by people on there that the side-effects could, in some cases, be very unpleasant over the first few days but would ease off. So I had to get the first week over. It was by the fourth day that I began to feel okay and decided to try a drink. It was a glass of red wine and I think it must have lasted me an hour and a half. I still wasn’t feeling too good but much improved than on the previous days.

So it was to be that after a week I was not really bothered by side effects. A little nausea and cold sweat to begin with but that soon subsided. Some people discontinue the drug before the first week is over but I persisted. One thing I learned early in the process is that you have to take the tablet every time you drink, not just when you want not to drink, so I should not have stopped the tablet at the weekend when I wanted to drink.

Over the following weeks I kept a diary of my drinking. Looking back, I am guessing my normal intake was between 70 and 100 units plus per week. I found that whilst on Nalmefene, I was consistently well under the recommended limits advised for men and very often below the limits for women. I was also having several alcohol-free days each week that I was now planning, and not taking a tablet on those days as I was confident I would not have a drink. This was the first time in years I could say that!

In the back of my mind I knew we had a holiday abroad booked and the normal pattern on holidays is to have a drink, probably daily.

Nalmefene blocks the Opioid receptors that give the brain pleasure from alcohol. It is important to know that there are many healthy activities which release endorphins which stimulate the same opioid receptors. These are things such as eating certain sweet and spicy foods, riding rollercoasters, extreme sports, exercise, having sex, cuddling babies and stroking animals. For this reason, the pleasure of these activities would be diminished on days that they took a pill. It is therefore necessary to avoid drinking and Nalmefene on the days you do these other activities if you want to gain maximum pleasure from them.’ (5)

There was a high risk I would drink on a daily basis whilst on holiday and therefore also the likelihood that I may not receive the same pleasure from other normal activities whist taking the tablet on a daily basis. Well, I did drink on a daily basis but a very much reduced amount compared with what I would normally have done. I usually had a beer in the afternoon. Just the one! In the evening, a glass of wine with a meal that I eventually lost the taste for on many an occasion. Then I started to have a Gin and Tonic with friends later in the evening and that was sufficient for me. Looking back, I have to admit that I made a few excuses to have an early night and I probably was not the life and soul of the party.

On our return to England, I continued to reduce my drinking to the point where I was only drinking a couple of evenings a week. This was where I wanted to be at. This was my goal. I know longer needed that drink every night. I could look at alcohol in the house and my wife having a drink and I wasn’t bothered.

My goal was achieved. Not quite, I am afraid!  I found that as I needed to take Nalmefene less and less, the times when I did need it, to have a drink, the side effects returned. This was not in the plan and, I understand it, something that does not happen to most people once they have been on the drug after several months. I had been on it around four months at this point. I could not continue like this. I did not want to become abstinent from alcohol, which was never my intention. Yet, I could not enjoy having a drink when taking the drug. In fact, I was feeling ill on those occasions.

I sought help from a couple of knowledgeable people on the ‘Patient’ website forum(6). The advice was to discuss with my GP the possibility of changing to Naltrexone. So that’s what I did. I wrote to my GP, prior to an appointment, explaining how things were with me, and I also discussed the possibility of changing over to Naltrexone. (I find it well worth while writing to a GP prior to meeting with them if the issue is a complex one, given the short amount of time that is allocated for a consultation.)

My GP was not against the idea of prescribing Naltrexone but asked me to abstain from alcohol for one month and then make another appointment with him. He would then prescribe it if I still wished to pursue this. At the time, I could not understand his rationale for asking me to abstain from drinking. He was aware I was drinking very little anyway and only when protected by Nalmefene. I could no longer take Nalmefene, due to the side effects, so I was in effect being put at risk of drinking again, unprotected. I later realised that his rationale was more than likely that Naltrexone is only licenced for use in alcohol conditions where the individual is abstinent. The licenced use of this drug is to help reduce the craving for alcohol.

(The prescribing instructions for Naltrexone were agreed way back in the mid-1990's.  This was before it became apparent (via Dr Sinclair's 20 years’ worth of research) that it works better and produces much, much better results when used in conjunction with alcohol, in the same way that Nalmefene is doing so now. However, because Naltrexone is generic, meaning that any company can make it, there is no exclusivity on the profits anymore, and hence no pharmacy company will spend the millions of £s it would take to have the prescribing instructions changed.

During the approval procedure for Nalmefene, it was put forward that at the same time, naltrexone should be accepting for treatment in the same way, but the company who make Nalmefene successfully opposed this and the matter was dropped.

I can understand why, because they were protecting their investment in bringing Nalmefene to the market, but it is a shame.) (7)

After four weeks of abstinence, I saw my GP again expecting to receive a prescription for Naltrexone. Unfortunately, he had not known at my previous appointment that as a GP, he could not prescribe Naltrexone in the first instance. It had to be prescribed by a ‘Specialist’. As I had again written to him just prior to this appointment, updating him of my progress and my wish to proceed on Naltrexone, he had obviously only then done his research. I was not pleased at this setback as I was going on holiday over the following days and I was looking forward to enjoying a drink. Remember, it was never my intention to stop drinking altogether. I just wanted to be in a place where I could enjoy alcohol socially but within, if possible, the government guidelines.

My GP asked if I would be prepared to see a specialist to discuss the Naltrexone option. I agreed but was aware that this would entail a lengthy wait. Over the next two days, I considered making a private referral to a specialist but decided against this at this point in time. I also wrote again to my GP advising of my decision and asking him to postpone a referral to a specialist. I had made a hugely risky decision to have a drink while I was on holiday and see how it went. This was also a week before Christmas

I am not sure what I was expecting. I think that I thought once the alcohol touched my lips, I would get an urge to just drink and drink. Thankfully, that was not the case at all. The first drink I had was after a three hour hill walk; I called into a pub and enjoyed a very refreshing couple of pints of real ale. The following day in the evening I tried a glass of red wine. A couple of sips and I poured it back into the bottle. The rest of the week, I went on to enjoy the odd glass of wine and a beer or two. It was nothing excessive and well below government guidelines for men in the UK. I continued to do so over the Christmas and New Year period and was surprised at how well things were going. I was having a drink, not having any strong desire to have a drink every evening, and having several alcohol free days during the week.

In the back of my mind though, I always had the thought what if this doesn’t last and I revert to drinking every evening and get back to how I was before. I shared my experience with the forum on the ‘Patient’ website. As I thought, respected people on that forum with a lot of knowledge (who had previously warned against drinking unprotected) stated that studies suggested that people at different stages relapsed without the protection of Nalmefene or Naltrexone. What do I do about this?

I had an appointment to see my GP about another issue but he also wanted to discuss how I was with regard to alcohol. Although pleased with how things were going he also was concerned that I might go back to how things were previously. My Liver blood results Gamma GT was now at 40 (the norm being up to 70) My levels had previously been 170. He suggested to me that I look into who was available to see privately about Naltrexone and whether they took NHS referrals (he would fund if that was the case).

My search found me a Psychiatrist who only practiced privately. (He was retired from the NHS.) My enquiry was through a secretarial service and the first reply was that the Doctor would prescribe Antabuse and not the Sinclair Method. My response to that was:

‘Antabuse is a very old treatment to prevent alcoholics from drinking by providing an adverse reaction to alcohol. I am not an alcoholic (by definition) and don't need to totally abstain. The treatment I am looking for is Naltrexone. As someone who was mildly dependant on alcohol and have now had successful results using Nalmefene. (Selincro - A similar drug to NALTREXONE and can be prescribed through the NHS. See NICE guidelines))   I am now at the stage of drinking less than the recommended levels for a male in the UK. Liver Gamma GT level now at 40 (It was 170) The problem I have is that the less I required Nalmefene (as it is taken before you have a drink) the side effects returned making life quite unpleasant for me. I am now unprotected i.e. risking having a drink without medication. The issue for me is that my brain may well relearn and seek a greater reward from alcohol as the opiate receptors are no longer being blocked. This would put me back in trouble. 

I have researched Naltrexone and discussed online with individuals running private clinics and individuals taking the drug who assure me that Naltrexone does not produce the severe side effects that Nalmefene is known can produce. What is interesting is that with most people, although the first week can be problematic, the side effects dissipate after long term use as it did with me. However, as I reached the point of only drinking once or twice a week the side effects returned as I took the drug on those days only. I am aware that in the UK Naltrexone is licensed at the moment for people who have abstained and the drug is given to prevent cravings. However, as has been seen by The Sinclair Method (taken on board to a degree by the NHS with the availability of Nalmefene) it should be taken prior to drinking alcohol. Once ‘Pharmacological extinction' has occurred some people decide to abstain others may want to drink normally at sensible levels. For those people they must continue to take either Nalmefene or Naltrexone before they have a drink. 

I am wishing to use Naltrexone on the occasion I do have a drink to prevent a return to my old ways which is always a risk. I am aware that with Naltrexone, regular liver function tests are required (not so with Nalmefene and probably one of the reasons it is the drug of choice with the NHS) However, Naltrexone is a lot less damaging to the liver than alcohol.'

To my surprise his Secretary emailed me back to say that the Doctor would be prepared to prescribe me Naltrexone and offered me dates when he could see me. I deferred that until I was reassured that the local classifications for prescribing allowed the GP to continue prescribing on the NHS following the private consultant’s initial prescription.

I then looked into buying Naltrexone online. My concerns were not only the cost but the reliability of the companies and to try and not to end up being scammed. Again, with the help of a third party making a recommendation, I ordered Naltrexone from a reliable company.

I was feeling good and doing well but I had to know if I would be okay taking the Naltrexone if the need arose. I decided to take a dose to see, if any, what side effects may affect me. I did however, take a full 50 mg dose, the recommend start dose is 25 mgs but this had slipped my mind. The result was that I did not feel in any way ill as I did with Nalmefene (Selincro). I did, however, experience a slightly strange sensation similar to that of Nalmefene that was, to me, unpleasant. My personal thoughts are if I had taken the reduced dose of Naltrexone first and then continued with the drug, that would be something that may have reduced. In any case, I would have lived with it if I had to do so. The same could not be said of Nalmefene.

I made the decision to continue without Naltrexone. At this point in time, 16 months has passed with unprotected drinking. For a lot of that period I have kept within the new UK weekly safe alcohol unit recommendations of 14 units. There are times such as holidays and special occasions where I have gone over this but I would estimate around the old recommended limit of around 21-28 units for a male. Remember I was drinking every evening 70-100+ units per week before commencing treatment.

I presently have several alcohol free days per week. I do feel I am still in a good place to deal with this now.

 

Summary

I hope by writing about my personal experience this helps people to understand about this issue of ‘Mild dependency on alcohol'. Some may argue there is no such thing. You are either dependant on alcohol or you are not. In a way I agree with that. I also believe that there are many people who regularly drink at above ‘safe’ levels, who will never be thought of by others as having an alcohol problem. Many of those people do not believe they have a problem. The enlightened ones will be aware of the harm they are doing to themselves and hopefully seek help. I hope the information I have provided contributes to some of those people seeking that help.

 

Bibliography

  1. https://www.nice.org.uk/guidance/ta325
  2. http://www.turning-point.co.uk/
  3. http://neraf.org/
  4. http://www.cthreefoundation.org/about-the-sinclair-method.html
  5. Paul Turner RMN MSocSc - http://alcoholhometreatment.com/component/content/category/2-uncategorised
  6. http://patient.info/ http://patient.info/forums/discuss/browse/alcohol-consumption-23
  7. Joanna http://patient.info/forums/profiles/joannac3europe-654970