Fran Lowry

April 16, 2014

ORLANDO, Florida ― Initiating unobserved buprenorphine induction to treat opioid dependence may help lower barriers to care in this population, new research suggests.

Results from an observational study suggest that opioid-dependent patients attending a primary care clinic who were given a 1-week prescription of buprenorphine, written instructions, and then sent home and followed with telephone support showed that this approach was feasible and safe.

"Our main goal was to try to address the treatment gap that we know exists, especially in urban, safety-net settings," lead author Elenore Patterson, MD, MPH, from New York University Langone Medical Center and Bellevue Hospital, New York City, told Medscape Medical News.

The study was presented here at the American Society of Addiction Medicine (ASAM) 45th Annual Medical-Scientific Conference.

No SAEs

Despite the fact that there are effective treatments for opioid dependence, many patients are not getting the treatment they need, she said.

Dr. Elenore Patterson

"We hypothesized that one of the possible barriers to starting buprenorphine are for physicians to prescribe according to the Center for Substance Abuse guideline that stipulates office-based induction, with the patient in front of you while you do the induction," she said.

"The guidelines say that you need to have the patient come into your office, the patient needs to be in withdrawal, you need to give them their first dose while they are there, observe them, and titrate the medication while they are in your office. Obviously that is very time consuming," Dr. Patterson said.

In the current study, the investigators reported on their experience using unobserved buprenorphine induction at a single primary care, hospital-based center.

They analyzed data from 485 patients who were prescribed buprenorphine from January 2006 to June 2013. All patients met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for opioid dependence and were deemed appropriate for outpatient treatment.

The vast majority of patients (n = 404) were male; the patients' mean age was 47 years (range, 24-73 years); 147 patients were white, 140 African-American, 60 Hispanic, and the rest (n = 138) were of unknown ethnicity.

The majority of patients (n = 294, 61%) were on Medicaid, 11 were on Medicare, 111 patients were uninsured, 39 had commercial insurance, and insurance status was unknown for 30 patients.

Most patients had previously been treated with medications for opioid dependence, including 331 (68%) who had been receiving buprenorphine and 260 (54%), methadone.

All patients received an instructional handout, a 1-week written prescription for buprenorphine, and telephone support. Follow-up medical management visits occurred weekly to monthly, and a urine toxicology screen was sent at every visit.

General primary care health concerns were also addressed at follow-up visits.

Overall, the study showed that unobserved buprenorphine induction was feasible and safe, with very few adverse events, Dr. Patterson said.

There were a total of 36 adverse events. These included the following:

  • Precipitated withdrawal in 11 patients

  • Protracted withdrawal in 15 patients

  • Vomiting in 1 patient

  • Anxiety in 1 patient

  • Cravings in 3 patients

  • Fatigue in 1 patient

  • Lightheadedness/dizziness in 2 patients

  • Nausea in 3 patients

  • Chills/bone aches in 1 patient

There were no serious adverse events.

Treatment retention was robust for the population as a whole, Dr. Patterson reported.

Patients remained in treatment for a mean of 77 weeks (range, 0 - 347 weeks) for a 48% retention rate at 1 year. Forty-six patients were lost to follow-up at week 1.

Urine toxicology results showed that the longer patients remained in treatment, the lower were their rates of positive opioid urine screens.

"We realize that our study has limitations, including that it was an observational study and all inductions were unobserved. Also, a number of patients had large gaps in their treatment, and this may have led to an overestimate of their time in treatment," said Dr. Patterson.

"This way of initiating buprenorphine may be easier all around. The patients prefer it, and it is a way of lowering barriers to care," she said.

Useful in Primary Care

Commenting on the findings for Medscape Medical News, Richard Ries, MD, professor of psychiatry and director, Division of Addictions, at the University of Washington and Harborview Medical Center, Seattle, agreed that such a strategy could be useful in primary care settings.

Dr. Richard Ries

"This is a large, well-done but uncontrolled study showing that patients in a busy urban primary care setting do well with buprenorphine naloxone induction that is not directly observed but managed in a take-home fashion by prescribing a week's supply, along with printed directions and phone backup," he said.

"Busy primary care settings may not have the space or time for the 2- to 4-hour typical onsite induction period, and so both issues may act as barriers to engaging and treating patients whose care would be improved by using this medication," Dr. Ries said.

"This study showed few problems and excellent patient retention using the take-home induction method," he added.

Dr. Patterson and Dr. Ries reported no relevant financial relationships.

American Society of Addiction Medicine (ASAM) 45th Annual Medical-Scientific Conference. Poster 21. Presented April 11, 2014.

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