Canadian Gov Reneges on Funding for 2nd Phase Heroin Trials (SALOME)

I had just finshed writing about the success of the latest study by the North American Opiate Medication Initiative (NAOMI) when I stumbled on a news article titled, “Rehab centre upset after Quebec pulls funds for heroin study”. Slightly confused, I quickly read the article and discovered that the fucked up Harper government in Canada were again playing god with people’s lives and putting their ideology before science. Just days after the New England Journal of Medicine published the positive results for Canada’s latest heroin trial, the Harper Government has pulled funding for the second phase of the study called SALOME.

What is the NAOMI clinical trial? (Phase 1)
The North American Opiate Medication Initiative (NAOMI) was a randomized trial aimed at testing whether medically prescribed diacetylmorphine, the active ingredient in heroin, was more efficient than methadone therapy for individuals with chronic opioid dependence who were not benefiting from other conventional treatments. The results show that patients treated with injectable diacetylmorphine were more likely to stay in treatment and more likely to reduce their use of illegal drugs and other illegal activities than patients treated with oral methadone.
-SALOME Clinical Trial Questions and Answers

What is the SALOME clinical trial? (Phase 2)
The Study to Assess Longer-term Opioid Medication Effectiveness is a clinical trial that will test whether diacetylmorphine, the active ingredient of heroin, is as good as hydromorphone (Dilaudid®), a licensed medication, in benefiting people suffering from chronic opioid addiction who are not benefiting sufficiently from other treatments. Also, this study will test if those effectively treated with these 2 injectable medications can be successfully switched and retained to the oral formulations of the medications.
-SALOME Clinical Trial Questions and Answers

It has always surprised me that the conservative Canadian government actually agreed to fund this study but to pull out as soon as the first study produced such positive results raises my suspicions. Were they expecting the trial of heroin assisted treatment (HAT) to fail? Was the promise to fund the 2nd phase just empty rhetoric with the expectations that they would never have to fund part two of a failed study? Considering that the government has just recently introduced new harsher laws for small time drug users including mandatory sentencing and the success of the latest heroin trials, how can we not be suspicious of the Harper Government’s motives.

Rehab Centre Upset After Quebec Pulls Funds For Heroin Study
The Gazette
By Aaron Derfel
August 2009

A Montreal drug-treatment centre is accusing the provincial government of playing politics in killing funding for a three-year study to treat heroin addiction.

The cancellation of the $600,000 grant follows the publication this week of a study showing that giving heroin to hard-core addicts at the centre's supervised clinic leads to higher rates of recovery.

"We're very surprised because all the discussions that we had with the (Social Services) minister in the last few weeks were very positive," said Eric Fabrès, the centre's co-ordinator of quality services. "We can't understand why the minister has changed her position. ... But we find it very peculiar that at the moment that we published the results in the New England Journal of Medicine, the minister decided to withdraw her support from the project."

The study, titled the North American Opiate Medication Initiative (NAOMI), sought to analyze whether heroin-assisted therapy offers more benefit to addicts who want to kick their habit than standard methadone treatment.

The researchers monitored 251 addicts in Montreal and Vancouver. In Montreal, addicts were given heroin at the Centre de recherche et d'aide pour narcomanes.

The study found that among addicts who received heroin by injection, 88 per cent completed the recovery program, compared with a 54-per-cent completion rate for those who took oral methadone.

But researchers also discovered that 10 per cent of addicts who took Dilaudid, a legal prescription opiate known as hydromorphone, did as well as those on heroin.

For the second phase of the research, titled SALOME (Study to

Assess Longer-term Opioid Medication Effectiveness), scientists wanted to compare heroin and Dilaudid for a three-year period.

The rationale is that if Dilaudid is truly as good as heroin in helping diehard addicts recover, it would solve the legal problem of having to use heroin, Fabrès said.

"But without the funding, the project is dead," he added.

Geneviève Trudel, political attaché to Social Services Minister Lise Thériault, said the decision to cancel the grant was simply cost-cutting.

Related Articles:
Canada Provides the Final Proof Needed for Heroin Assisted Treatment
Quebec's landmark heroin study in jeopardy
SALOME: Clinical Trial Questions and Answers

Canada Provides the Final Proof Needed for Heroin Assisted Treatment

Once again, a trial of prescription heroin for long term addicts has proven to be superior to other treatments including Methadone Maintenance Treatment(MMT), buprenorphine and abstinence programs. The results of the study from the North American Opiate Medication Initiative (NAOMI) in Canada has been eagerly awaited as the final proof that heroin assisted treatment (HAT) is indeed a viable and effective solution. Of course, it’s just conversation unless more countries implement it as part of their drug treatment policy & health plans. I especially want the Australian government to look at the evidence and continue on from where the ACT trials abruptly ended. There’s no John Howard anymore to veto an almost unanimous decision and no Major Brian Watters to misrepresent the ANCD. More importantly, there is now more evidence than ever before and a almost universal acceptance that HAT is the most effective treatment for long term heroin addiction.

Study Backs Heroin to Treat Addiction New York Times By Benedict Carey August 2009 The safest and most effective treatment for hard-core heroin addicts who fail to control their habit using methadone or other treatments may be their drug of choice, in prescription form, researchers are reporting after the first rigorous test of the approach performed in North America. For years, European countries like Switzerland and the Netherlands have allowed doctors to provide some addicts with prescription heroin as an alternative to buying drugs on the street. The treatment is safe and keeps addicts out of trouble, studies have found, but it is controversial — not only because the drug is illegal but also because policy makers worry that treating with heroin may exacerbate the habit. The study, appearing in the current issue of the New England Journal of Medicine, may put some of those concerns to rest. “It showed that heroin works better than methadone in this population of users, and patients will be more willing to take it,” said Dr. Joshua Boverman, a psychiatrist at Oregon Health and Science University in Portland. Perhaps the biggest weakness of methadone treatment, Dr. Boverman said, is that “many patients don’t want to take it; they just don’t like it.” In the study, researchers in Canada enrolled 226 addicts with longstanding habits who had failed to improve using other methods, including methadone maintenance therapy. Doctors consider methadone, a chemical cousin to heroin that prevents withdrawal but does not induce the same high, to be the best treatment for narcotic addiction. A newer drug, buprenorphine, is also effective. The Canadian researchers randomly assigned about half of the addicts to receive methadone and the other half to receive daily injections of diacetylmorphine, the active ingredient in heroin. After a year, 88 percent of those receiving the heroin compound were still in the study, and two-thirds of them had significantly curtailed their illicit activities, including the use of street drugs. In the methadone group, 54 percent were still in the study and 48 percent had curbed illicit activities. “The main finding is that, for this group that is generally written off, both methadone and prescription heroin can provide real benefits,” said the senior author, Martin T. Schechter, a professor in the School of Population and Public Health at the University of British Columbia. Those taking the heroin injections did suffer more side effects; there were 10 overdoses and six seizures. But Dr. Schechter said there was no evidence of abuse. The average dosage the subjects took was 450 milligrams, well below the 1,000-milligram maximum level. About 663,000 Americans are regular users of heroin, according to government estimates. The researchers said 15 percent to 25 percent of them were heavy users and could benefit from prescription heroin. That is, if they ever were to get the chance. Heroin is an illegal, Schedule 1 substance, meaning it has a high potential for abuse and serves no legitimate medical purpose. That designation is unlikely to change soon, researchers suspect. In an editorial with the article, Virginia Berridge of the London School of Hygiene and Tropical Medicine concluded, “The rise and fall of methods of treatment in this controversial area owe their rationale to evidence, but they also often owe more to the politics of the situation.”

Heroin Assisted Treatment in a Pill

Although heroin assisted treatment (HAT) and the many heroin trials have all been very successful, it is still not the perfect solution. Having to visit a clinic 2-3 times a day and the problems associated with injecting are the 2 main obstacles for patients. Some smart cookie in Canada though has come up with a fantastic idea that might go a long way to treating hard core addicts without these obstacles. Heroin in a pill.

The idea of providing morphine, heroin or hydromorphone to hard core addicts is not new and when put into practice has had great success. Sadly though, through blind ignorance, selling the proposal that drug addicts are given addictive drugs legally to inject has not been easy with the media often whipping up a storm of drug hysteria and governments scared of a public backlash. Supplying the drugs via a pill may be the answer. Fear of take away supplies being diverted to the black market would still be a major concern for many so there would need to be a strict monitoring system in place. It is achievable though with a well thought out system. Diversion though, in the real world becomes less of an issue when this simple question is asked:

Why would patients sell their high quality, legal heroin? ... to buy low quality street heroin?

Methadone may be the default treatment but it certainly has it’s problems. As someone who has been on methadone, buprenorphine and Slow Release Oral Morphine (SROM) to treat my heroin addiction, I can testify to the superiority of a morphine pill. Methadone often leaves the patient ‘flat’ which usually doesn’t happen when given drugs like Morphine. For those who don’t respond to methadone, detox. or rehab, having more options can only be beneficial. Once we start getting serious about treating addiction without the accrued bias from years of misinformation, morphine, heroin or hydromorphone in a pill becomes attractive. With strict guidelines, therapy/counselling and close monitoring, we might finally begin to help those long term users who don’t respond to current treatments and continue to use street drugs.

Can Pill Replace Heroin For Addicts?
CTVBC
Febuary 2009
Video report from CTV British Columbia's Maria Weisgarber


Researchers behind a controversial approach to Vancouver's drug problem are trying to launch a new study.

Hundreds of people took part in the NAOMI project, which stands for North American Opiate Medication Initiative. The project provided drug addicts with heroin, methadone and a pain medication called Dilaudid.

Rob Vincent took part in NAOMI. He says his health improved and he was able to work.

"I didn't have to worry about waking up in the morning and worry about where I'm going to come up with the money to get better now," he said.

Now there's a proposal for a similar study, called SALOME (Study to Assist Longer Term Opiod Medication Effectiveness) which would eventually test whether injectable drugs could be replaced with a pill.

"If you could get some people onto oral medication they could be treated much more simply," said Dr. Martin Schechter, a former NAOMI researcher.

The province has called NAOMI's results promising -- but says it's waiting for peer-reviewed published findings. Meanwhile, research advocates hope Tuesday's budget will include money for an international research treatment centre in BC.

"We have world class leading expertise here in Vancouver today," says Trish Walsh with the Inner Change Foundation. "We're just not giving them the tools to do the job."

The NAOMI project ended up finding pain medication worked just as well as heroin. But Dr. Schechter says when the three year study ended, so did the benefits for many of the participants.

"What we've learned is some of the people...a significant proportion of the people that were doing well subsequently relapsed in the first six months," he said.

Rob Vincent relapsed more than once.

"If you're going to make a project such as that where you're going to get everybody's hopes up...at least make it so it's continuous, and if you are going to have a cut-off date, have some sort of back-up, so that they're not just being thrown out back onto the street," he said.

The new project being proposed is another three year study.

Another Successful Heroin Trial - Canada

Finally, the results are in from the North American Opiate Medication Initiative (NAOMI) enquiry into prescription heroin. Ironically though, it’s a bit of a fizzer. It just told us what has already been proven over and over again ... that prescription heroin is a vastly superior treatment than all other current or proposed programs for heroin addiction.

Canada is just the latest country to produce evidence that prescription heroin is more effective than methadone or abstinence based programs. Switzerland, Germany, The Netherlands and Spain have all had heroin trials and documented their success. The UK is currently finishing off their own trial which is already indicating similar results. Belgium, Israel, Denmark and other countries have announced they will also be conducting their own trials or have indicated their interest in doing so.

All participants reduced their involvement in crime and their spending on drugs, and all participants had health improvements, but those in the injectable heroin or hydromorphone group saw the greatest improvements overall. 
-Jessica Werb. Health Straight Talk

Many countries will now be in that political quagmire that faced Australia back in the late 1990s. Is it worth risking political points and the inevitable attacks from the anti-everything brigade for implementing the safest and most successful treatment program to tackle heroin addiction? Luckily this time around, Australia won’t have John Howard to override the consensus of the states or fellow politicians but the Rudd government is yet to prove itself in providing an evidence based policy. There has been no clear direction yet from the government except the usual political posturing about being tough on drugs. Rudd did claim that he would support evidence based policies but drug policy doesn’t always follow the usual rules. Is this going to be too much of a stretch for a church going conservative? Are the likes of Drug Free Australia (DFA) and the twats from the MSM going to derail another attempt at treating a medical problem based on science and research?

Results show that North America’s first heroin therapy study keeps patients in treatment, improves their health and reduces illegal activity
North American Opiate Medication Initiative (NAOMI Study)


VANCOUVER, BC, October 17, 2008 – Researchers from the North American Opiate Medication Initiative (NAOMI Study) today released final data on the primary outcomes from the three-year randomized controlled clinical trial.

“Our data show remarkable retention rates and significant improvements in illicit heroin use, illegal activity and health for participants receiving injection assisted therapy, as well as those assigned to optimized methadone maintenance,” says Dr. Martin Schechter, NAOMI’s Principal Investigator, Centre for Health Evaluation and Outcome Sciences and Professor and Director, University of British Columbia School of Population and Public Health. “Prior to NAOMI, all of the study participants had not benefited from repeated standard addiction treatments. Society had basically written them off as impossible to treat.”

The data, which was collected from 251 participants at sites in Vancouver and Montreal, demonstrate that a combination of optimized methadone maintenance therapy (MMT) and heroin assisted treatment (HAT) can attract and retain the most difficult-to-reach and the hardest-to-treat individuals who have not been well served by the existing treatment system.

Key findings at the 12-month point of the treatment-phase of the study showed that HAT and MMT achieved high retention rates: 88 per cent and 54 per cent respectively. Illicit heroin use fell by almost 70 per cent. The proportion of participants involved in illegal activity fell by almost half from just over 70 per cent to approximately 36 per cent. Similarly, the number of days of illegal activity and the amount spent on drugs both decreased by almost half. In fact, participants once spending on average $1,500 per month on drugs reported spending between $300-$500 per month by the end of the treatment phase. Marked improvements were also seen in participants’ medical status with scores improving by 27 per cent.

Of particular note amongst the findings, participants receiving hydromorphone (DilaudidTM) instead of heroin on a double-blind basis (neither they nor the researchers knew) did not distinguish this drug from heroin. Moreover, hydromorphone – an opiate licensed for the relief of pain - appeared to be equally effective as heroin, although the study was not designed to test this conclusively. According to the NAOMI Study Investigators, further research could help to confirm these observations, allowing hydromorphone assisted therapy to be made more widely available.

While a comprehensive health economics study is pending, researchers have already determined that the cost of continued treatment is much less than that of relapse.

“We now have evidence to show that heroin-assisted therapy is a safe and effective treatment for people with chronic heroin addiction who have not benefited from previous treatments. A combination of optimal therapies – as delivered in the NAOMI clinics - can attract those most severely addicted to heroin, keep them in treatment and more importantly, help to improve their social and medical conditions,” explains Schechter.

A summary report of the findings and background information on the study are available at: www.naomistudy.ca

 

NAOMI trial finds heroin more effective than methadone
By Jessica Werb
Health Straight Talk

Heroin-assisted therapy is a safe and highly effective treatment for people with chronic heroin addiction, according to the final data released by the North American Opiate Medication Initiative (NAOMI) today.

The three-year randomized controlled clinical trial, lead by Dr. Martin Schechter of UBC’s School of Population and Public Health, included 251 participants at sites in Vancouver and Montreal. Forty-five percent were given oral methadone, 45 percent were given injectable heroin, and 10 percent were given injectable hydromorphone, an opiate licensed for pain relief.

Those treated with heroin had a retention rate of 88 percent, compared to 54 percent for participants who received optimized methadone maintenance therapy.

Sixty-seven percent of those treated with heroin responded to treatment, compared to 47.7 percent of those treated with methadone.

Illicit heroin use declined in all patients, but was declined most sharply among those treated with injectable heroin or hydromorphone.

All participants reduced their involvement in crime and their spending on drugs, and all participants had health improvements, but those in the injectable heroin or hydromorphone group saw the greatest improvements overall.

The study also found that participants receiving hydromorphone did not distinguish it from heroin, and that it appeared as effective in treatment as heroin. However, researchers noted that the study was not designed to test this conclusively.

Given their less-than-enthusiastic reaction to InSite, I wonder how Stephen Harper and the RCMP are going to react to these findings?