The latest in these efforts are forthcoming FDA guidelines around medication-assisted treatment (MAT) for opioid abuse. According to The New York Times these will include:

  • Clarification of the kind of evidence drug manufacturers need to develop new monthly injectable forms of the existing medications for opioid abuse
  • Guidance that encourages “more flexible and creative designs” of medication-assisted therapy studies, which tasks researchers with developing new ways to evaluate the effects of MAT formulas

An FDA official told The New York Times that these guidelines will encourage drug makers to develop new, longer-acting formulas of the three FDA approved opioid treatment drugs: buprenorphine, methadone and naltrexone. They’ll also encourage endpoints that don’t gauge MAT effectiveness on complete abstinence, but instead show substantial reductions in use, cravings and overdoses.

They hope to “correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective.” The official noted that they’re looking for medications that could help patients function better when used in combination with social support and therapy. They also hope to raise the number of specialty opioid abuse treatment programs that offer medication-assisted treatment.

Measuring Success in Opioid Dependence Treatment

I absolutely agree that we shouldn’t consider anything short of abstinence as a failure of treatment. The perspective of abstinence or nothing only serves to perpetuate the feelings of shame that many people suffering from addiction are already trying to overcome.

Unfortunately, the nature of addiction is that many people will relapse. In the case of opioids, some research pegs relapse rates at around 90%. However, these remission rates can be greatly improved with adequate treatment including the use of MAT and directing careful attention to risk factors for relapse, including underlying social and psychological stressors.

I measure success for people in early recovery from opioid abuse and dependence by looking for a reduction in the frequency of their relapses and if the amount they use is progressively decreasing. If they do relapse, it’s critical to identify what triggered the relapse and address those triggers directly through talk therapy or behavioral interventions.

The Importance of Addressing Underlying Issues

While I encourage the development of any new medication to help with the opioid abuse epidemic, I believe the FDA’s proposal to lower the standard by which medications are approved may be somewhat misguided. The MATs currently available are highly effective when used appropriately. The ball is “dropped” in opioid dependence – or any addiction – when the psychological factors that underlie substance abuse are not given careful attention.

There isn’t any foreseeable way in the present or near future in which we can address “other aspects” of the addiction through medications. If research dollars are available for this sort of study, that’s great, but we shouldn’t be staking our immediate hopes on it.

The reality is that few, if any, patients with severe addictions are using substances for the sake of pleasure. This misconception is at the core of the old notion that addiction is a moral failing. The majority of these patients have had adverse childhood experiences such as neglect or physical or sexual abuse, or haven’t learned healthy ways to cope with how difficult life can often be. Because of these issues, they struggled to learn to manage their emotions on their own.

When people with these types of histories are introduced to opioids, either illicitly or by medical necessity, they quickly learn that opioids provide relief in the immediate moment and are an effective way to control their negative emotions. Then, addiction develops. Tolerance and physical dependence cause them to spend increasing amounts of their personal resources on drugs.

The fatigue from this fruitless pursuit is often what brings patients in for addiction treatment, but by this point they’ve usually been struggling for several years. Medication for opioid abuse and dependence can help people temper cravings and withdrawal symptoms so they can begin to address these underlying difficulties, but it can’t do that critical therapeutic work for them that will help them maintain long-term abstinence.

The Prospect of New MATs for Opioid Dependence

The gold standard of outpatient MAT is currently buprenorphine. I believe that any new medication would need to either beat that in a head-to-head trial or have a significantly improved safety profile. This unfortunately is not how drug trials typically work though because it’s incredibly hard and expensive to do so.

There are already some new formulas on the market. For instance, there’s a new formulation of a buprenorphine injection that’s designed to last one month. This could be helpful because it reduces the problems that arise when someone has access to a 30-day supply of medication. These can include diversion and struggling with taking the medication daily and as exactly as prescribed.

There’s also an implant that promises to last six months. I don’t agree with this approach because it eliminates the patient’s need to maintain accountability through their prescriber and those providing therapy. They may never return for follow-up after the medication is implanted.

Access to Opioid Addiction Treatment

At least in the region where I practice, I’m not sold on the idea that access to MAT is really a primary problem unless we’re talking specifically about the financial barriers to beginning treatment. I’m aware of several well-run opioid abuse treatment centers that aren’t at capacity. That said, there are also many that aren’t providing or recommending sufficient psychological and behavioral support to address the underlying difficulties behind the addiction.

There’s also still a significant stigma associated with seeking help for addiction. With growing national attention to the opioid abuse crisis, I hope this is changing. Even in 12-step communities, you will find many people that believe MAT is in some way cheating.

We wouldn’t consider people with high blood sugar cheating for taking insulin while they work on modifying their diet. Why would we view people using MAT as cheating while they work on modifying the factors that led to and perpetuate their addiction?

How Do We Address the Opioid Crisis?

If I were designing plans to address opioid abuse on a national level, I would:

1. Focus on addressing the underlying psychological difficulties that drive the addiction.

The resources that are still lacking are not medications; it’s more that underlying trauma and emotional difficulties driving addiction aren’t getting enough attention. In many ways, this stems from cultural problems in our society. We tend to have difficulty acknowledging the prevalence and pervasiveness of trauma.

In my work at The Ranch treatment center, I see people begin kicking their addiction because of the intensive effort they put into tackling the root causes of their substance abuse. This happens through the guidance of clinicians specially trained in trauma, addiction and mental health disorders, and the specialized therapies and approaches that are proven to work for these issues.

2. Reduce the initial financial barrier for access to medication-assisted treatment.

If we could find a way to lessen the financial barriers to beginning MAT, say by better insurance reimbursement for the medication, even exploring subsidizing their first few months in opioid treatment, this might be all it takes for people to get their feet back under them – just enough to then support their own treatment. Given the significant physical and financial comorbidities associated with addiction, I believe we’d see an excellent return on investment.

3. Keep medication-assisted treatment checkpoints in place.

Measures including routine drug screening and random pill counts are critical to ensure patients are compliant with treatment and not diverting drugs. A large part of what is therapeutic about MAT isn’t just the medication itself but the treatment relationship and behavioral patterns that are formed through taking a prescribed medication. Diversion inhibits the need for patients to maintain this healthy treatment relationship.


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