A closer look at the evidence (Part 2)

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This is the second post in a series taking a look at the evidence provided by advocates of medication-assisted treatment (MAT).

The first section below provides the background. If you’ve already read the first post, skip ahead part 2.

This post looks at 5 more (of the 19) studies from the meta-analysis provided by Newt Gingrich, Patrick Kennedy & Van Jones.

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You may have heard that the unlikely crew of Newt Gingrich, Patrick Kennedy & Van Jones have taken interest in addressing the opioid crisis. More allies is a great thing.

They strongly advocate for medication-assisted treatment as the standard of care:

Medication assisted treatment, or MAT, is the use of FDA-approved medicine in concert with behavioral counseling for opioid addiction that has proven efficacy. Multiple studies have shown that MAT is essential to effective long-term recovery, by reducing cravings and the risk of fatal overdose and increasing abstinence and time in treatment. And we have known this for a long time. In 2003, a multicenter clinical trial published in the New England Journal of Medicine (NEJM) found that buprenorphine reduced the craving to use an opiate by roughly 50 percent and increased the odds of not taking an opiate by about 3.5 times.  MAT is the widely accepted and scientifically proven method for successfully treating opioid addiction – and the National Institute on Drug Abuse, the World Health Organization, UNAIDS and many other physician groups all recommend it as the standard of care.

They use the word “recovery” in the title of their article and conflate recovery with access to MAT.

Is that accurate? Fortunately, they provided sources for their statements so we can take a look at their evidence.

But first, consider what you want out of treatment. What would you consider a successful outcome?

  • Returning to work/school?
  • Restoration of family life?
  • Restoration/creation of supportive social networks?
  • Participation in community life?

Well, they provide 2 studies for their evidence.

The first is a meta-analysis (a study of studies) and the second is a regular old study.

The outcomes these studies measure are: retention in treatment; decrease in illegal opioid use; decrease in mortality; decrease in nonopioid drug use; decrease in criminal activity; decrease in risk behaviors related to HIV and hepatitis C.

These are very important outcomes, especially the ones that could be the difference between life and death. However, I think it’s fair to say that most patients and families would consider these necessary but not sufficient.

A closer look at the evidence (part 2)

Over the course of several posts, I’m going to dig into the findings from these studies.

The meta-analysis provides a review of the 19 studies and a summary of each.

Let’s look at the studies. Some of them consider the effects of various doses and other factors. I’m just going to report on the outcomes above.

Study 5

This study compared levomethadyl acetate, buprenorphine, and high-dose methadone and low-dose methadone

52% of drug tests from Levomethadyl acetate subjects were positive for opioids, 62% of tests from high-dose methadone and buprenorphine subjects, and 79% of tests from low-dose methadone patients.

The closest they came to reporting on abstinence is as follows, “The percentage of patients with at least 12 consecutive opioid-negative urine specimens differed significantly among groups, ranging from 36 percent in the levomethadyl acetate group to 8 percent in the low-dose methadone group.” (There were 3 drug screens each week.)

The reported also testing for cocaine, but did not provide results.

Regarding retention, they reported that, “Overall, 51 percent of the patients completed the 17-week trial (53 percent of the levomethadyl acetate group, 58 percent of the buprenorphine group, 73 percent of the high-dose methadone group, and 20 percent of the low-dose methadone group).”

It’s worth noting that the buprenorphine dosing was unusual. “Buprenorphine was administered at a dose of 16 to 32 mg on Mondays and Wednesdays (to approximate a dose of methadone of 60 to 100 mg daily)11; the Friday doses were 50 percent higher (24 to 48 mg).”

Study 6

This study compared 4 weeks of office-based treatment with buprenorphine/naloxone vs buprenorphine alone, or placebo

The study reported the following drug testing outcomes, “Opioid negative screens: buprenorphine/naloxone group, 17.8%; buprenorphine group, 20.7%; and placebo group, 5.8%”.

Study 7

The study examined a 12 month buprenorphine program that included monitored dosing and psychotherapy.

This study had outstanding outcomes: “One-year retention was 75% in the buprenorphine group and 0% in the placebo group (p=.001). Roughly 75% of the patients retained in treatment had negative urine screens for illicit opiates, stimulants, cannabinoids, and benzodiazepines.”

Of course, this outlier got me very curious about the details of the study.

It’s worth noting that it was a small study (only 20 receiving buprenorphine) and the inclusion criteria were pretty restrictive. They excluded anyone with 4 or more years of daily heroin use, three or more unsuccessful treatment attempts in abstinence-oriented treatment, and those with a codependence on alcohol, amphetamines, cannabinoids, or benzodiazepines. Other exclusion criteria included any cognitive impairment or psychiatric disorder (unless the patient was stable).

This study was done in Sweden and the treatment was unusually comprehensive.

. . . individual treatment plans were developed in collaboration with social services departments to address issues of housing and occupation (ie, employment, studies, or occupational therapy). Throughout the study period, patients had 45 min individual counselling sessions every week in the treatment unit. We took supervised urine samples thrice weekly under conditions that prevented manipulation of samples. . . .

A contingency management plan was part of the treatment plan, and was thoroughly communicated to the patient during the induction week. If a patient completed a continuous 6-months drug-free (for all drug categories) verified by urine analyses, take-home doses were allowed so that frequency of visits could be reduced to thrice weekly. If relapse occurred—ie, illicit drug intake was reported, or indicated by urine samples positive for drugs, then daily supervised administration was resumed. If a patient did show signs of relapse (such as a positive urine sample, non-attendance at appointments, or both) we offered additional support, including intensified counselling, and ultimately, admission if needed. More than two positive urine samples within 3-months (for any banned substance) would lead to discharge from the study unless the patient agreed to and complied with intensified support efforts as described previously. Other predetermined criteria for involuntary discharge from treatment were failure to attend for more than 7 days, violent behaviour, or dealing in drugs. Discharged patients were all referred to standard clinical treatment at a different site.

So, this treatment approach appears to be unusual in that it was limited to relatively low-severity opioid SUDs and offered some big carrots (housing and employment) and a big stick (termination).

Study 8

This study compared methadone and buprenorphine in pregnant, opioid-dependent women and focused on withdrawal syndromes (NAS) in the babies.

“No significant difference in illicit opioid use between groups. Total of 20.0% and 45.5% of BMT-exposed and MMT-exposed neonates, respectively, were treated for NAS (p=.23). Other primary outcomes were also not significantly different, except that the BMT-exposed neonates had a shorter average hospital stay (p=.021).”

Study 9

This is another Swedish study comparing adaptive, BMT stepped care versus MMT.

No differences between groups were found for retention (76% for both at 6 months) or the proportion of negative screens (80% for both groups).

This one has good outcomes but there’s a lot I don’t understand. This study doesn’t provide the detail the other Swedish study did.

Maybe these Swedish studies are the basis for the insistence that MAT plus behavioral counseling has proven efficacy? However, the meta-analysis itself says, “The addition of structured psychotherapy to standard treatment— which may include peer support services, 12-step programs, and other psychosocial treatment provided at the facility or office—has not been shown to improve outcomes for patients on opioid maintenance therapy.”

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Note: This is not an argument against access to any kind of care. It’s just a push for good informed consent that empowers patients to advocate and choose for themselves.

 

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