Finding a new intervention for methamphetamine use disorder while tackling social issues and stigma
Researchers from the Centre hospitalier de l'Université de Montréal are working on making treatments easier and more accessible for people living with substance use disorder
Methamphetamine-related hospitalizations and deaths are on the rise, and so is the demand for harm reduction services. But there is currently a lack of evidence-based intervention for methamphetamine use disorder. Most studies on opioids were outdated as they focused on heroin use, and not the use of much stronger substances.
The OPTIMA clinical trial aimed to improve models of care for managing opioid use disorder. The team’s new study will focus on lisdexamfetamine and contingency management as promising interventions for methamphetamine use disorder, alone and in combination.
Through the OPMTIMA clinical trial, the research team confirmed that a model of care with a more accessible treatment was safe and effective in reducing opioid use among Canadians.
Clinical research into mental health, addiction, and substance use is complicated by historic underfunding, stigma, and various social determinants of health, but researchers nevertheless remain dedicated to making treatments easier and more accessible for those living with substance use disorder. This is why the Canadian Research Initiative in Substance Misuse (CRISM) was established in 2015. CRISM is a national network of researchers, service providers, policy makers and people with lived experience.
One of CRISM’s researchers is Dr. Didier Jutras-Aswad, an addiction psychiatrist and researcher at the Centre Hospitalier de Université de Montréal (CHUM), where he heads a lab that specializes in mental health, substance use, and addiction.
Data from OPTIMA clinical trial supported more flexible models of care
One of his team’s most recent trials was on opioid use, which aimed to improve models of care for managing opioid use disorder. Dr. Jutras-Aswad and other colleagues involved in the Canadian Research Initiative on Substance Misuse (CRISM) decided to start the study, called OPTIMA, after finding that most studies on opioids were outdated as they focused on heroin use, and not the use of much stronger substances like fentanyl. But the medical intervention for opioid addiction was also burdensome on the patients, requiring daily direct supervision of methadone or buprenorphine/naloxone intake at a clinic or pharmacy for three months and sometimes longer. The team found a less demanding but equally effective intervention by using a model of care that allows for take-home buprenorphine/naloxone early in treatment.
“What we were trying to do with OPTIMA was first conduct a trial looking at the effectiveness of methadone and buprenorphine/naloxone in a population of people who were using more potent opioids, but also trying to bring a much more flexible model of care for buprenorphine/naloxone, which allows for less supervision and less demanding models of care,” says Dr. Jutras-Aswad.
“The trial showed that actually being much more flexible, less demanding with buprenorphine/naloxone was not less effective at reducing opioid use than methadone, which gives data to clinicians to discuss with patients about more flexible approaches,” he adds.
Or as the published paper put it, “this trial confirmed that a model of care with flexible, take-home buprenorphine/naloxone doses was safe and noninferior to closely supervised methadone treatment in reducing opioid use among Canadians.”
A new clinical trial to address the lack of evidence-based intervention for methamphetamine use disorder
Dr. Jutras-Aswad and other CRISM colleagues are now turning their attention to methamphetamine use disorder, which has no known approved interventions. According to the Canadian Centre on Substance Abuse, methamphetamine-related hospitalizations and deaths are on the rise, and so is the demand for harm reduction services. But there is currently a lack of evidence-based intervention for methamphetamine use disorder, and so finding one is the goal of his trial.
The research team is focusing on lisdexamfetamine and contingency management as promising interventions for methamphetamine use disorder (MUD), alone and in combination. They will replace methamphetamine with high doses of lisdexamfetamine, a safe and prescribed stimulant, but their study does not focus on the drug alone. The team will also test whether providing financial incentives to support engagement in care, in addition to standard psychosocial interventions, will be efficient to help people with MUD decrease substance use.
Engaging people with lived and living experience from the beginning
An addictions trial brings together compounding factors, including psychological issues or a lack of housing or income that must be dealt with. It also raises questions around how to evaluate the findings from a clinical trial that involves vulnerable populations. This is why the research team engaged people with lived and living experience to co-design the study and determine most relevant outcomes to measure.
“You cannot design and evaluate a clinical trial conducted in vulnerable populations with complex conditions [the same as] a medication for, for example, high blood pressure with a relatively stable population and where your outcome is simple to measure,” explains Dr. Jutras-Aswad. “The way to evaluate substance use disorder research should be different, and a key starting point is to focus on what matters the most to those living with such multifaceted disorder” he says.
More work needs to be done to address a historic deficit in mental health and addiction research
While enthusiastic about the trial, Dr. Jutras-Aswad also reminds us that much remains to be done in that field. “There are still a lot of consequences of stigma,” he says. “Historically, mental health and addiction disorders were not sufficiently funded; we still see it in the clinical settings where the budget and the funding for mental health and substance-related disorders is not always sufficient, is not on par with what the problem represents for society and for people.”
“When you look at clinical trials involving some substance-related and mental health disorders… we often don’t have the [same] number of trials and interventions [as you do for other conditions] to guide clinical decisions. Sometimes you have an intervention based on three trials, six trials, nothing like the body of evidence you have to guide interventions for other conditions,” says Dr. Jutras-Aswad.
The historic deficit in addictions research is a challenge that must be overcome. Concerted research efforts such as those conducted by the CRISM and other funding initiatives are key to face such challenge. Dr. Jutras-Aswad believes that the trial on methamphetamine use disorder is especially timely as there is little research conducted on methamphetamine use which remains a burdensome condition in Canada and elsewhere. Whereas many trials consist of tweaking an existing intervention or making small changes to dosages, here the team is tasked with finding the first adequate medical intervention for methamphetamine use.
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