Tapered buprenorphine therapy is far less effective than maintenance therapy for patients dependent on prescription opioids who seek treatment in the primary care setting, to the extent that it should be used “sparingly, if at all,” according to a report published online Oct. 20 in JAMA Internal Medicine.
General practice and family medicine physicians are the most frequent prescribers of buprenorphine, and they routinely must decide between pharmacologically assisted withdrawal (tapering) and ongoing maintenance treatment, even though the data to guide these decisions are quite limited. “In practice, patients often request and receive medication taper instead of maintenance therapy, and office-based physicians may be enthusiastic to provide tapers because this method allows them to treat more patients, fits with what many patients request, and could reduce the need for long-term opioid therapy,” said Dr. David A. Fiellin, professor of medicine, public health, and investigative medicine at Yale University, New Haven, Conn., and his associates.
The investigators performed a single-center, open-label randomized clinical trial to compare the two approaches in 113 patients who were dependent on prescription opioids. All the study participants received ongoing care from primary care physicians and nurses trained in addiction medicine, as well as from drug counselors, throughout the 14-week treatment phase of the study, which included frequent 15- to 20-minute visits focused on drug abuse education, management of withdrawal symptoms, overdose risk, and relapse prevention.
All the study participants had a 2-week induction period in which they were stabilized on buprenorphine, followed by 14 weeks of active treatment, then 2 weeks of continuing clinical care after treatment completion. A total of 56 patients were assigned to a steady dose of buprenorphine for the 14-week treatment phase, while 57 were assigned to tapering: 4 weeks on a stable dose of buprenorphine followed by 3 weeks of gradually decreasing doses (approximately 2 mg every 3 days). The tapered group was given prescriptions for NSAIDs, an antiemetic, a sleeping aid, and clonidine to manage opioid withdrawal.
The primary outcome measure – the overall percentage of weekly urine samples that were negative for the presence of opioids – was significantly lower in the tapering group (35.2%) than in the maintenance group (53.2%). The two groups had similar percentages of negative samples for the first 7 weeks of the trial, when all patients were receiving full-dose buprenorphine, but the percentage then increased only in the tapering group, who were no longer receiving full-dose buprenorphine. Dr. Fiellin and his associates reported (JAMA Int. Med. 2014 Oct. 20 [doi:10.1001/jamainternmed.2014.5302]).
Patients in the tapering group also achieved fewer consecutive weeks of self-reported opioid abstinence (2.7 vs 5.0), were more likely to require transfer to a more intensive treatment program (28% vs 5%), and were less likely to complete the trial (11% vs 66%).
“Buprenorphine taper should be used sparingly, if at all, in primary care treatment of patients dependent on prescription opioids,” the investigators said.
This study was supported by the National Institute on Drug Abuse. Reckitt-Benckiser Pharmaceuticals supplied the buprenorphine through NIDA. Dr. Fiellin reported ties to Pinney Associates and ParagonRx for serving on expert advisory boards to monitor for diversion, misuse, and abuse of buprenorphine.