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Important Suboxone study requires careful interpretation

November 9, 2011
by Gary A. Enos, Editor
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Disappointing results for counseling do not necessarily suggest no role for therapy

The first known randomized controlled study of medication treatment for patients dependent on prescription opioids demands a careful read, suggests its lead researcher, since disappointing results for counseling as an adjunct to medication should not be interpreted as diminishing any role for talk therapy.

A study published online this week in the Archives of General Psychiatry is already generating buzz in a field closely monitoring trends in the use of the buprenorphine-naloxone combination sold under the brand name Suboxone. The two-phase study offered a pair of highly surprising results: The presence of counseling as part of treatment appeared to have little effect on outcomes for patients dependent on prescription opioids, and overall outcomes were very poor for patients once they were tapered off extended buprenorphine-naloxone treatment.

But lead researcher Roger D. Weiss, MD, of Harvard Medical School and McLean Hospital, says that the results for adjunctive counseling must be interpreted very carefully, since the group that received this counseling in the study was compared with individuals who received more intensive medical management than what is typically available in a physician’s office.

“Standard medical management in this study is pretty good counseling,” says Weiss. “Doctors in the community usually see patients only once a month. Here, doctors were seeing patients for 15 to 20 minutes a week. We didn’t want to say to these patients, ‘See you in a month, and we’ll hope for the best.’”

In essence, says Weiss, that particular aspect of the study design “raised the bar high for counseling to jump over” in the effort to achieve better outcomes than medical management without counseling.

The adult study involved 653 treatment-seeking outpatients who were dependent on prescription opioids; researchers said this population is important to examine in research because nearly all prior studies of opioid treatment have involved patients dependent on heroin. Those patients who did not succeed in the first phase of study treatment (involving a two-week buprenorphine-naloxone stabilization) were enrolled in 12 weeks of extended medication treatment, which was followed by a four-week taper and an 8-week post-medication follow-up.

The study compared outcomes for buprenorphine patients receiving “standard medical management” and those receiving manual-based opioid dependence counseling. The standard medical management visits encompassed strategies such as assessing cravings and recommending abstinence and self-help group participation. The more extensive opioid dependence counseling from behavioral health professionals, says Weiss, employed relapse prevention and 12-Step strategies. “We wanted a counseling program that was essentially off the shelf,” he says.

Researchers found that while only 6.6% of patients had successful outcomes in the first phase of treatment, 49.2% were successful in extended buprenorphine-naloxone treatment. No differences in outcome based on the extent of counseling received were observed in either of the two phases.

The researchers also found that patients’ success rate eight weeks after completion of the medication taper in phase two was only 8.6%. “We would not have expected the patients to have done as poorly as they did after the taper,” says Weiss. This finding certainly paves the way for further investigation into the optimal duration of buprenorphine treatment.

But the finding on counseling is likely to gain the most attention in the treatment field, particularly given that the advent of advanced medication treatments for addiction has come with the proviso that medications are most effective when used in conjunction with counseling. While Weiss acknowledges that the research team expected better results from counseling in this study, he warns against any blanket conclusions drawn from this outcome.

Weiss points out, “A lot of patients in this study were not particularly enthusiastic about having counseling. They wanted the medication—that’s what they were there for,” reflecting the sense of excitement that has been prevalent in the patient community about the availability of Suboxone to treat opioid dependence.