There was a lot of enthusiasm about this study on twitter recently.
It appears to be based on this program highlighted in the NY Times last year.
. . . city health workers are taking to the streets to find homeless people with opioid use disorder and offering them buprenorphine prescriptions on the spot.
The city is spending $6 million on the program in the next two years, partly in response to a striking increase in the number of people injecting drugs on sidewalks and in other public areas. Most of the money will go toward hiring 10 new clinicians for the city’s Street Medicine Team, which already provides medical care for the homeless.
Members of the team will travel around the city offering buprenorphine prescriptions to addicted homeless people, which they can fill the same day at a city-run pharmacy.
We’ve reviewed the evidence-base for buprenorphine in previous posts. (And, that the outcomes were not what most people imagine when they hear that it’s the most effective treatment or the gold standard for care.)
A frequent criticism of research is that it doesn’t reflect real world conditions.
Well, this study that actually used real-world, high complexity subjects, and examines an intervention getting a lot of recent attention—low barrier buprenorphine prescribing. The reported the following conclusion:
In conclusion, this study found that a low barrier buprenorphine pilot program successfully engaged and retained a subset of marginalized persons experiencing homelessness in care and in continued treatment with buprenorphine.
What was the intervention being studied?
The researchers studied a low-threshold, same day buprenorphine program co-located with medical outreach and harm reduction services, which they described as follows:
Patients are engaged by peer outreach workers or self-present on a drop-in basis to either a small open-access medical clinic or a nearby syringe access program, where a clinician provides comprehensive substance use assessment and education and calls in a same-day prescription for buprenorphine/naloxone to be filled at a community pharmacy that dispenses the medication free to patients who are uninsured or have Medicaid.
This is especially relevant because of growing calls for this type of low-threshold opioid agonist program.
Who was being studied?
The subjects received a buprenorphine prescription from the street medicine program and were complex cases.
The researchers did a retrospective chart review of 95 patients:
- 100% used heroin and engaged in injection drug use
- 61% used methamphetamines
- 26% used cocaine
- 8% used benzodiazepines
- 12% met criteria for unhealthy alcohol use
- 100% were homeless
- 58% had a chronic medical condition, such as hypertension or hepatitis C
- 66% had a psychiatric condition
- 26% with bipolar disorder or a psychotic disorder.
- 24% previously sought treatment at this program
How long was the study?
The study was 12 months. (That’s very good. This is considerably longer than most studies. The ideal duration would be 5 years, but studies of that duration are extremely rare.)
What outcomes did the study measure?
This study looked at 4 outcomes over 12 month:
- Retention in the program’s medical and harm reduction services
- Retention on buprenorphine
- Urine drug screen results
Retention in care
Retention in the street medicine program, defined as a visit 1 week prior to or any time after each time point:
- 74% returned for follow-up after the initial visit at least once during the 12 months of evaluation.
- 63% at 1 month
- 53% at 3 months
- 44% at 6 months
- 38% at 9 months
- 26% at 12 months
Retention on buprenorphine
Retention on buprenorphine, defined as having active buprenorphine prescriptions for more than 2 weeks of the month:
- 55% at 1 month
- 41% at 3 months
- 38% at 6 months
- 34% at 9 months
- 26% at 12 months
- 46% had a treatment interruption of 1 month or longer with subsequent return to care
Those percentages seem to be reporting on the % at that particular check-in time, not continuous up to that point.
- Twenty-nine patients (30%) were retained on buprenorphine for at least two of the evaluation time points (months 1, 3, 6, 9, or 12).
- Of that 30%:
- 14 (48%) had continuous active prescriptions for buprenorphine during the time they were treated.
- 5 (17%) of these patients had an interruption in their buprenorphine prescription of 2–3 weeks,
- 8 (28%) had an interruption of 4–6 weeks, and
- 5 (17%) had an interruption of greater than 6 weeks. Seven patients (24%) had multiple interruptions.
Urine drug screens
Two hundred and six urine toxicology tests were completed by the cohort, and 71% of patients who followed up after intake had a toxicology test, with a mean of 2.7 tests and a median of one test per follow-up patient (range 0–25).
If 74% of the 95 followed up after intake, that’s 70 patients. If 71% of them had at least one drug screen, that’s about 50 patients.
The median of one test per follow-up patient would indicate that at least half had only 1 drug screen.
Of the 206 drug screens completed:
- 63% were positive for opioids
- 73% were positive for methamphetamines
- 25% were positive for cocaine
- 10% were positive for benzodiazepines
- 81% were positive for buprenorphine
- 23% of patients had at least one opioid-negative, buprenorphine-positive toxicology test.
Emergency department and hospital records were reviewed for adverse events, including deaths and nonfatal opioid overdoses.
- 1 patient died from fentanyl and methamphetamine overdose
- 4 patients received emergency or inpatient medical treatment for an opioid overdose requiring naloxone,
- 1 of these patients had three overdoses that required naloxone,
- 5 patients were treated for possible opioid overdose events not requiring naloxone
What we don’t know
There are a few questions the study didn’t answer that could have been answered with the data and outcome measures used:
- How many subjects were continuously on buprenorphine?
- Were there any subjects were negative for opioids and other drugs at all points (or most points)?
- The article says that patients were offered referrals to methadone and residential treatment. How many accept those referrals and, if successful referral rates are low, why?
- Were there any quality of life benefits for the patients?
The study had some interesting thoughts on drug testing and outcomes:
Our urine toxicology results reflect adherence to buprenorphine concurrent with ongoing use of heroin and methamphetamines in a majority of the cohort. We found some evidence of periods of opioid abstinence, with 23% of patients having at least one opioid-negative, buprenorphine-positive test. In our clinical experience, many patients report taking buprenorphine regularly and using substantially less heroin, while still using heroin occasionally. We are exploring this phenomenon further through qualitative research and in-depth interviews with participants, as it is difficult to measure a decrease in amount of heroin use with the binary tool of a urine toxicology test.
And, under limitations:
Frequency of urine toxicology testing varied among participants, so results could be skewed by participants who had more tests and may not be an accurate reflection of the cohort’s substance use. We are not able to report or compare toxicology test results among individual participants at specific time-points because of the variability in testing practices.
Treatment as harm reduction or recovery facilitation?
This discussion of outcomes highlights the tension between treatment as harm reduction and treatment as recovery facilitation.
A recent opinion piece in Emergency Medicine News brings this tension into focus:
Despite press coverage to the contrary, this study [work done by the group led by Gail D’Onofrio, MD, at Yale on ED-initiated buprenorphine/naloxone for opioid use disorder] never demonstrated any impact of ED-initiated buprenorphine on the only objective measure used to assess sobriety, the urine drug screen, nor were any other outcome differences sustained at six months. (JAMA 2015;313:1636; http://bit.ly/2PBwYWd; J Gen Intern Med 2017;32:660; http://bit.ly/2Cj0lbY.)
Despite this, I’m convinced that within the next five years buprenorphine will be routinely administered in EDs for opioid use disorder.
I imagine that most people who are enthusiastic about these projects would respond that they are not looking for “sobriety.”
This is where clarity about goals for an intervention becomes especially important. If we can agree that addiction is a treatable chronic illness, it seems important to more clearly categorize interventions as treatments for the illness of addiction or as palliative care.
If we sell an intervention as treatment at the public level but treat it as palliative care at the academic level, the public, people with addiction, and people who care about them are likely to feel deceived. It also has the effect of eliding difficult conversations about resource allocation and capacity development. For example, is this $6,000,000 allocated to palliative care or addiction treatment? Because it’s not both.
UPDATE: Follow-up post here.