The First International Conference On Heroin Maintenance: Clinical and Treatment Issues, William Shanahan

We have been giving heroin to people for many years, as indeed have many of my colleagues around the United Kingdom, but few people have actually managed to get a big enough group together to do any worthwhile research on them. Although like Dr. Haemmig we have realized that sometimes giving people heroin seems to be a good thing the cry from the people who give us our money is, well, that may be fine in practice but how does it work in theory? And we have had to go and try to look for some of that theory.

Basically I run a 200 slot clinic which deals with people with drug problems, HIV problems and Hepatitis B and C, obviously since about 90% of our heroin users are now Hepatitis C positive. We have other problems such as TB which is increasing for us, all the infections associated with injecting and all the problems you know about if you work in drug centers.

Our idea was to see if we could give a group of people heroin as diamorphine and/or methadone and see how they got on. So we did not have a rationale which was based on double blind perfect trial. We just decided we would do a naturalistic study and assess the results.

We tied this in with therapies, which we were using anyway, which were: counseling on a daily, weekly, fortnightly basis, depending on the level which the client was at. Group work, occupational therapies of which we have several types, including art therapy and batik groups. We have an acupuncturist and we have an aromatherapist.

Obviously, I am a psychiatrist so we have psychiatric assessments and colleagues of mine do medical follow-ups and tutorials in safer injecting which people find (to our surprise) extremely important. We look at alcohol use and obviously dual diagnosis as mentioned earlier since many of our clients have psychotic illness or depressive illnesses, sometimes associated with the drug life-style itself

Therefore we had 120 injectors and we wanted to look at a research protocol which would be as tight as possible for our researcher to use and attractive enough for our funders to fund. I also have to mention that we are really driven in the UK by what our funders want. If we do not offer worthwhile proposals based on clinical evidence, we do not get funding.

Now, in a way, because we started small we came at this slightly differently from our colleagues in Holland and Switzerland in that we did not really need to convince the Department of Health in the UK that it was a good think for us to do this, we just did it. Then we told them well we have started it what do you think? They said well you can do 40 or maybe 50 [patients] and finally they said well you can do 60.

Thus we ended up recruiting over and above the 60 people we already had. We had 60 people of whom, as I will show you, about 58 people were studied for a 12 month period. So it is a very short period and regrettably it is a very small number and like some of the trials mentioned earlier risked not standing up to close statistical scrutiny.

But what we were hoping was that if we could show that we could do any sort of reasonable work with this group then we might be able to encourage the funders to put money into the UK wide trail. We are almost there in that we had a meeting last week with people from around the UK who are now willing to involve themselves in a UK trial.

But we're a bit damned if we do and damned if we don't in that people criticize us for giving heroin in the first place and then criticize us for not giving enough of it when we do give it. We also have had great difficulty with the dosing basically because we cannot afford to stay open after 6:00pm. Therefore we have to send people home with doses. It just did not seem possible for us to go from a methadone upper limit of 60 mg (used in some clinics) to 600 mg of methadone and to give people that to take home with them.

Not surprisingly there has been a lot of bad press over methadone deaths recently with children drinking it and people dying suddenly. I don't know why this is happening right now, maybe its new reporting, but the overdoses from the heroin continue nonetheless.

We decided to base our research on the methadone research coming from here (the US) and to use the research here in terms of higher doses. We looked at reasonable as being 200 mg of methadone. From the slide you have just seen showing equivalent doses of heroin you could argue that we should be looking at about 700 mg of heroin. We were in no position to do that. We certainly would never have been allowed to do it and we would not have received funding for it. Therefore we decided to keep the methadone doses similar to the heroin dose. So we actually offered people 200 mg of both.

I am grateful to my colleague Nicola Metrebian who was the lead researcher on this paper.

This was our background. Looking at the fact that we were under a lot of pressure to prescribe injectables, people were saying that no matter how much methadone we gave them they would not do well, and it was clear to us that despite many years of methadone treatment people were still using injectable heroin. Therefore we decided for this reason to push this trial ahead.

We wanted to see whether giving the injectable opiates to the opiate dependent users would be associated with health and social gains. The design was observational. Clients were able to choose which drug they wanted. We had our dose limit as I said. The dispensing was on site in the initial periods, and we used assessment instruments. We used the OTI from Australia, which was validated there and we validated it again ourselves in the UK.

Basically, we ended up being able to look at 58 people over 12 months. Interestingly although they had choice, only 64% took heroin as their first choice, 36% still preferred methadone. Of our sexual split 72% were male, 86% were white, the medium age was 38,and they were an older age group than the group we had had previously in the methadone maintenance clinic. The medium length of injecting was 19 years. We had a medium of four previous failed opiate treatments.

We have quite a tight protocol. People have to be over 21 and have to have been on methadone for a long time and have failed two attempts at high dose methadone maintenance. Our retention rates were better than our best known methadone trial but not as good as we expected. This may of course reflect the fact that the doses were not as high as people say they should have been. In any event, at the end of 12 months, we had 57% still in treatment; 17 had been discharged for violation of the protocol.

It was difficult to get discharged. Really people had to be quite abusive to the staff, which would really account for people who actually took alcohol on top of the drug. We have very little trouble from the opiate users. Across the clinic in general we get very little trouble from opiate use as a pure drug, it is always when there is something else around such as cocaine or alcohol that we tend to find problems.

Five people defaulted, 7% moved on to oral methadone for choice and health reasons, 3% went to prison and we can take it that they were continuing to indulge in illegal activities, and 3% requested a move to oral methadone. One detoxed and one died from alcoholic liver disease which she had had before we started on the trial.

So looking at the mean doses at 3 months and at 12 months our mean dose of heroin was 185 mg. Now, people could, as I said, have 200 mg but a lot of people tolerated out under the 200 mg when we tested them. They my well have been a self-selecting group in that once those who felt they would need more [methadone] got word from the streets that our dose limit was 200 mg, may not have turned up. I have no doubt there is a group out there who would have come if we had given doses similar to our colleagues in Switzerland. At the end of 12 months the dose was slightly higher whereas the average dose of heroin rose from 181 mg to 185 mg per day. The average dose of methadone rose from 148 mg (at 3 months) to 161 mg (at 12 months).

Referring to the changes in the proportion using illicit drugs, in all cases, people are using less illicit drugs by virtue of the fact that we are giving them drugs, which is obviously the outcome we were hoping for.

The proportion involved in criminal activity over 12 months, high on entry had a very good significant drop after 12 months. Much of this data had to come from self-reporting and the report from the local police on people who were known to probation and people we had who had previously been in trouble with the law and we had to really try very hard to track down just how they were doing. Also, a lot of our clients work in the sex industry and we needed to see how many of those had stopped doing that.

The opiate treatment index is an enormous questionnaire, which covers all aspects of health and social functioning. We looked at three big areas here: social functioning, general health and psychological adjustment. Again we found improvements in all these areas which were significant following treatment.

Regarding the HIV status the OTI recognizes all injecting as a risk factor, so obviously if we give people heroin who were previously on methadone (even though they wanted heroin) they will naturally end up injecting more often, and this tended, of course, to mark them down as having had a negative gain, but [it] misses the fact that they are now injecting clean drugs with clean works and probably not getting any [of the] money that they used to for methadone.

So our conclusions were that we did attract and retain opiate dependent users with long injecting careers and multiple failed treatments by even giving them the dose of 200 mg which we prescribed. Heroin was not always the preferred choice.

Significant gains were made in the first 3 months and sustained themselves for the period.

The trial has been going for 3 years and we can tell now that any gains we made in 3 months persisted for the 3 years, and it was a good indication of how things were likely to go.

The dosing level of the group we took on was generally under 200 mg. Just as a point of interest the heroin group tended to have been using heroin, obviously, on admission, in that they were more likely to have been using heroin previously than the methadone group who may have been using both. The methadone group tended to be much more likely to use other drugs such as cocaine and benzodiazepines.

We saw no change at all in the use of alcohol or the use of cannabis. In fact, most of our users regard cannabis as something not even worth mentioning anymore. It is just inevitable, something you take with your coffee in the evening and is not to be confused with substances. We did not look at nicotine at all because there really wasn't much point.

With other drugs we included in our protocol, which of course, is different from the Swiss study, the need for people to detox from other drugs if they wanted to come on the trial, and this also may have meant that people were less likely to come in. We figured if we wanted to get funding we would have to show our funders that we were getting something back besides, of course, the fact of keeping people alive and well. We opted to get cocaine users to stop using cocaine if they wanted to stay on the program.

This was not a dischargeable offense. What we did instead was, if you ended up on 6 ampoules for example, and if you showed no tendency towards reducing your cocaine use over the first 3 months, we dropped 1 ampoule and substituted it with oral methadone, and so on. This was remarkably effective, and may people actually did clean up just to gets their amps back.

But is was, in a way, a rather punitive regime and I think we are hoping that in the UK Injectable Project, which we hope to get off the ground soon, we will be able to be less rigid about the use of other drugs. But there is still quite a school in the UK who feel that if we are going to give drugs like injectable opiates, we should be able to get something back such as a cessation of use of other drugs.