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Buprenorphine taper less effective than ongoing maintenance therapy for opioid dependence

December 29, 2014
by Julia Brown, Associate Editor
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A recent study examining primary care-based buprenorphine taper versus ongoing maintenance therapy for prescription opioid dependence sheds some light on the association between buprenorphine taper duration and treatment outcomes, which has not been well understood. Researchers found at the conclusion of the 14-week clinical trial that tapering was in fact less effective than ongoing maintenance therapy.

The study was conducted due to the lack of evidence-based guidelines for primary care physicians to decide between the two methods of treating patients. In specialty addiction treatment settings, using buprenorphine—an opioid replacement therapy used to treat opioid addiction—remains controversial and many programs hesitate to use it for anything beyond short-term detox.

Enrolled in the trial were 113 patients with prescription opioid dependence that were randomized to buprenorphine taper or ongoing buprenorphine maintenance therapy. According to the results of the study, the mean percentage of urine samples negative for opioids was lower for patients in the taper group (35.2%) compared with those in the maintenance group (53.2%). Additionally, patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine.

The study also notes that patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group, and that patients in the taper group were less likely to complete the trial (11%) than those in the maintenance group (66%). Sixteen patients in the taper group reinitiated buprenorphine treatment after the taper due to relapse.

14-week breakdown

According to lead author David A. Fiellin, MD, professor of medicine, investigative medicine and public health, Yale University School of Medicine, the duration of the study was chosen in order to provide adequate time to have patients stabilized on a dose of buprenorphine (6 weeks), undergo a three-week taper, allow one week of abstinence to avoid precipitated withdrawal once patients were offered naltrexone treatment, and undergo at least four weeks of observation after taper. The maintenance group received ongoing buprenorphine therapy.

“Our goal in choosing the period for the medication taper was to mirror what physicians were doing in routine clinical practice,” he says. “We surveyed physicians who were providing buprenorphine in office-based settings as to the average duration of their tapers. The results indicated that the majority provided a two- to three-week taper.”

Fiellin adds that it’s important to note that the study was conducted using buprenorphine in prescription opioid-dependent patients who were treated in primary care settings. Results using other medications, in patients with dependence on other opioids such as heroin, and treated in other more specialized settings may differ.

Ongoing care and counseling

All patients received ongoing care from physicians, nurses and drug counselors over the duration of the trial, he says. Primary care physicians with training in addiction medicine provided physician management to all patients during 15- to 20-minute visits, and nurses' counseling was provided during weekly 20- to 30-minute sessions.

Additionally, all patients received weekly on-site drug counseling in 45-minute sessions conducted by doctoral- or master’s-level clinicians. 

In order to assist with symptom management and challenges to relapse during and after the medication taper, nurse counseling and drug counseling tailored to manage withdrawal symptoms and achievement and maintenance of abstinence were offered more frequently, up to two additional 20-minute sessions per week each, during and after the period of medication tapering, the study manuscript states.

While Fiellin says he’s unaware of randomized clinical trials that have assessed varying durations of buprenorphine taper in prescription opioid-dependent patients treated in primary care, he says that the National Institute on Drug Abuse-funded Prescription Opioid Addiction Treatment Study trial found high rates of relapse following medication taper among prescription opioid-dependent patients after two weeks of stabilization and two weeks of tapering. 

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Comments

I always review disclosures in research involving pharmaceuticals. Often, funding produces results favorable for the source.
In this study, the sample of 113 divided into 2 random groups of n=56 is small.
Here is the disclosure: "Conflict of Interest Disclosures: In recent years, Dr Sigmon has received consulting payments from Alkermes and, through her university, has received research support from Titan Pharmaceuticals. In the past, Dr Brooklyn was a paid mentor in the Physician Clinical Support System for training physicians in buprenorphine use. No other disclosures were reported."
Dr Sigmon designed the study and the Buprenorphine was supplied by the companies.
It would be wise to not jump to conclusions about going to maintenance as opposed to taper without further research. Taper may be a healthier regimen whereas maintenance more profitable for the pharmaceutical suppliers.

Thank you Arthur for finding and pointing out this critically important fact.

In addition, I'd like to point out how misleading the headline is. A more accurate headline might be:

"14-week opioid dependence treatment compares the use of a Buprenorphine taper to ongoing maintenance therapy"

A statement can't be made for one or the other being generally more effective in treating "opioid dependence" after a mere 14 weeks. That is far over-reaching.

My response to the findings that the group that's on maintenance medication had slightly fewer positive drug screens for illicit opioids in the *short-term* is, "duh".

These short-term results are abysmal for both the taper and maintenance group, which probably has more to do with the quality of the counseling regimen that accompanied the drug dispensing.

I'm disappointed in the editing of Addiction Pro and makes me wonder about other disclosures that may need to be made. I believe there's a role for medication but this study and commentary do little to help find it.

As a clinician I'm interested in helping people find freedom from addiction for a lifetime. For example, how do maintenance medication schedules and various treatment approaches correlate to long-term reprieve from addiction and overall functioning of individuals?

Is it possible that short-term "positive" results using medication maintenance correlate with negative long-term results? I hope we find out soon.

How many of the 113 patients had Chronic Pain? Did this study factor that in?