A new study on initiation of buprenorphine maintenance was just published. The press release describes the intervention as an alternative to “revolving door” detox and relapse cycles:
“patients who start long-term buprenorphine treatment at a detox program, instead of going through detox and getting a referral for such treatment at discharge, are less likely to use opioids illicitly over the following six months, and more likely to keep up treatment”Study finds alternative to ‘revolving door’ of opioid detox and relapse
The study was recently published in the journal Addiction. Let’s take a closer look at the study.
1) What is the treatment or intervention being studied?
The researchers compared two service models in a short-term inpatient detoxification unit:
- 5‐day buprenorphine managed withdrawal protocol and passive referral with “a full list of local substance use treatment options as well as primary medical care follow‐up options.”
- Buprenorphine induction, inpatient dose stabilization and post‐discharge transition to maintenance buprenorphine at an affiliated primary care clinic.
2) Who were the subjects?
Subjects were recruited from a medically supervised treatment facility that provides, as usual care, evaluation and withdrawal management using a methadone taper protocol for those with opioid use disorder, along with individual and group counseling and aftercare case management. On average, patients stay for 5.7 days. The program is also associated with a methadone maintenance program and a primary care‐based buprenorphine program. Within 24 hours of admission individuals were approached by the study team, who described the study and asked permission to complete a brief eligibility screen.
“Study inclusion criteria included age 18 years or older, interested in initiating maintenance buprenorphine/naloxone treatment and willing to establish primary care after discharge with a buprenorphine provider at the nearby SSTAR health center in Fall River. Exclusion criteria included: not able to provide informed consent (due to acute illness, cognitive impairment, psychosis or not able to complete the study in English), having a history of allergic reaction to buprenorphine or naloxone, surgery in the coming 6 months, pregnancy, a current DSM‐IV diagnosis of schizophrenia, 20 or more days of use in the last month of sedative/hypnotic drugs, cocaine or alcohol (because the out‐patient program would not accept direct linkage of high‐levels of non‐opioid substance use), current suicidality, current homelessness or plans to leave the area within the next 6 months.”
3) How long was the study?
This is good. 6 months is a relatively long-term study.
4) What outcomes did the study measure? (How did they define success?)
“Our outcomes of interest were (1) mean 30‐day rate of use of illicit opioids and (2) prescribed buprenorphine treatment days at 1, 3 and 6 months’ follow‐up.”
Treatment engagement and retention are important things to evaluation, but treatment is not recovery and may not reflect the goals of people with addiction and their loved ones.
The other outcome was illicit opioid use, which is more directly related to recovery. However, it’s worth noting that this does not include other drugs or prescribed opioids.
5) What were the study methods? What’s the quality of the evidence?
All participants completed follow‐up assessments at the end of their in‐patient stay (day 5), a week following discharge (day 12) and then at 1 (day 35), 3 (day 95) and 6 months (day 185) post‐discharge; all post‐discharge follow‐up assessments included a urine toxicology and compensation (day 12: $40, day 35: $50, day 95: $50, day 185: $50). Participants provided a urine specimen for toxicological testing (instant screens) at each assessment.
6) What did the study find?
Treatment days: By the end of the study:
- 69% of maintenance patients were still using buprenorphine more than 10 days per month.
- 39% were using buprenorphine on a daily basis.
Illicit opioid use: When the researches excluded missed drug screens, they found significant less illicit opioid use in the maintenance patients during the study, but these differences shrunk to non-significant levels by the end of the study.
When they treated missed drug screens as positive drug screens, the maintenance patients used illicit opioids 4-5 fewer days per month. The graphs below suggest that the maintenance patients averaged around 12 days of illicit opioid use per month versus around 16 days per month for the detox and passive referral patients.
7) Were any actual or potential conflicts of interest?
“The study medication was supplied by Indivior as an unrestricted, unsolicited grant of non‐financial support. Indivior had no role in study design; collection, or analysis and interpretation of the data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.”
8) What questions does the study not answer?
Note: No study can answer all questions and any study that tries to answer all questions is likely to do so poorly. This is not meant as criticism as much as context.
- We don’t know anything about use of prescription opioids, illicit drugs (other than opioids), or alcohol use.
- We don’t know anything about quality of life or restoration of functioning in life domains.
- We don’t know how this intervention would compare to a decent program. Opioid detoxification with passive referral to ongoing care is very poor care.
- We don’t know how much (or how little) the subjects look like real-world patients. The study screened out 77% potential subjects. And, of the eligible subjects, 70% chose not to participate and another 13.5% either left the facility or were determined ineligible.
- The researchers speculate that buprenorphine recipients benefited from protection from overdose. There were no deaths in either group, but the study did not report whether there were differences in nonfatal overdose.