Office-Based Therapy for Opioid Use Overrides Treatment Protocols

NEW HAVEN, Conn., July 26 -- The efficacy of office-based treatment and counseling for opioid addiction with Suboxone (buprenorphine-naloxone) was roughly about 40% in spite of variations in the protocols, according to researchers here.

Results of a 24-week randomized, controlled clinical trial showed that a primary-care, office-based setting with counseling by trained primary care nurses helped these patients, reported David Fiellin, M.D., and colleagues, of Yale in the July 27 issue of the New England Journal of Medicine.

"Although we did not demonstrate the superiority of extended counseling or thrice-weekly medication dispensing over relatively limited nurse-administered counseling and once-weekly dispensing, our findings support the feasibility of buprenorphine-naloxone maintenance in primary care," Dr. Fiellin said.

Suboxone treatment allows certified office-based physicians with supervised nurses to initiate and manage treatment of the patients directly in the office, a method shown to be more effective than opioid-treatment programs, he said.

In the study, 166 opioid-dependent patients (heroin or prescription opioids) at the Yale-New Haven Primary Care Center were assigned to one of three clinical treatment schedules in which drug dispensing patterns and counseling duration were varied.

The efficacy of brief weekly counseling and once-weekly medication did not differ significantly from that of extended weekly counseling and thrice-weekly pill dispensing, said Dr. Fiellin, and colleagues.

Standard medical management involved brief (20 minutes), manual-guided, medically focused counseling by trained primary care nurses. Enhanced counseling differed only in the extended length of each session, the researchers said. They used Suboxone tablets, which, they said, deliver buprenorphine-naloxone in a 4:1 ratio.

Results for the three schedules were similarly effective with respect to the mean percentage of opioid-negative urine specimens. Efficacy of standard medical management and once-weekly medication dispensing was 44%; efficacy for standard management and thrice weekly medication dispensing was 40%; and for enhanced management and thrice-weekly dispensing, efficacy was also 40% (P=0.82), the researchers reported.

All three treatments were associated with significant reductions from baseline in the frequency of illicit opioid use, but there were no significant differences among the treatments. The proportion of patients remaining in the study at 24 weeks did not differ significantly. For the standard counseling and weekly medication, 48% remained; for thrice weekly dispensing, 43% remained; for those getting enhanced management and thrice-weekly dispensing, 39% remained (P=0.64), the researchers reported.

All three treatment protocols resulted in a reduction in the mean self-reported frequency of opioid use from 5.3 days a week (95% confidence interval, 5.1-5.5) at baseline, to 1.1 days (CI, 0.9 to 1.3)during induction, to 0.4 day (CI 0.2 to 0.7) during maintenance (P<0.001). However, there were no significant differences among the three treatment groups (P=0.73), the researchers reported.

The proportion of patients with at least one cocaine-positive urine specimen during the study did not differ significantly among the three groups, they added.

The mean dose of buprenorphine, 17.5 mg/day during the maintenance phase, did not differ significantly in the three treatment groups. After a two-week induction period, patients received 16 mg of buprenorphine daily for 24 weeks. Successive increases to 20 mg and 24 mg were permitted, depending on the patient's level of discomfort or evidence of three weeks of illicit drug use. Take-home medication was provided for the days without office dispensing.

The mean percentages of patients who completed the 24-week study, which ranged between 39% and 48%, were similar to those found in previous studies, including one conducted in an office-based setting, the researchers said.

Among the study's limitations, was the sample size, which could not account for patients lost to follow-up. Also, because the confidence intervals were wide, it was not possible to conclude definitively that there were no clinically significant differences among the three treatments, they said.

In this same vein, they mentioned that counseling interventions differed primarily in duration but not in content and were not tailored to individual patients. In addition, the eligibility criteria limit the findings to patients who do not have severe and untreated psychiatric conditions or a dependence on alcohol, benzodiazepines, or sedatives, although patients with personality disorders and cocaine abuse were included.