A new study published in the American Journal of Medicine offers a clear indication that not all opioid-dependent patients require the same approach to treatment, with one subset of patients clearly benefiting from medication-assisted therapy with rather modest physician support.
What is important to note in interpreting the results of this study in a primary care setting is that it does not conclude that cognitive-behavioral therapy (CBT) is not useful as an adjunct to medication treatment—only that for the particular subgroup of medication-using patients that made up this study sample, adding CBT to physician support did not improve drug-using outcomes.
“I view opiate dependence as a disease that occurs across a spectrum,” study lead author David A. Fiellin, M.D., said in an interview with Addiction Professional. “For some patients, the primary issue can be addressed with medication and a level of counseling that’s consistent with a medical model. For others, such as those with comorbid conditions, they are better served in a setting with a higher level of services.”
The details of the study composition are critical to understanding and interpreting the results. Fiellin, professor of medicine, investigative medicine and public health at the Yale School of Medicine, and colleagues studied 141 opioid-dependent patients being seen at Yale-New Haven Hospital’s Primary Care Center. Among the patients excluded from the study were any individuals with alcohol, cocaine or benzodiazepine dependence, or any with psychosis or untreated major depression. Therefore, the study sample did not generally have significant comorbid behavioral health issues.
Patients received daily doses of the Suboxone formulation of buprenorphine for 24 weeks; doses were set at 16 mg a day but could be increased to 20 mg or 24 mg if patients were experiencing withdrawal symptoms or were continuing to engage in opioid use.
Once stabilized, patients were randomly assigned to receive either physician management alone or physician management with CBT. Physician management consisted of 15-to-20 minute sessions with internal medicine physicians, starting weekly and decreasing in frequency from there, and focusing in part on brief advice for maintaining abstinence. The CBT sessions occurred for 50 minutes on a weekly basis for the first 12 weeks of treatment; the services were delivered by trained master’s- and doctoral-level clinicians.
Fiellin explains that in designing this study, the researchers purposely tried to create a true separation in intensity between the physician management and the CBT. This is because in a previous study that Fiellin led (published in 2006 in the New England Journal of Medicine), the counseling that was offered to patients receiving Suboxone was delivered under a nurse model of care, and no difference was detected between 15 minutes of counseling per week and 45 minutes per week.
But again in this latest study, looking at primary outcomes of self-reported frequency of opioid use and consecutive weeks of abstinence confirmed by urine testing, there were no significant differences between the physician management only group and the physician management plus CBT group. Both groups showed similar improvement over the course of the study.
These findings led the researchers to state in their article, “The results of this study do not support the routine addition of cognitive-behavioral therapy to physician management in patients receiving buprenorphine treatment in primary care.”
Yet the researchers added, “However, our findings of no difference should not be interpreted as equivalence between the two treatments.”
Rather, the study found that for the subset of patients specifically examined in this sample, physician management at a relatively low level of support can work much in the same way that treatment of chronic conditions such as diabetes does. But for patients with untreated psychiatric comorbidities or additional substance use problems, brief counseling from physicians likely would fall short. “There are certain patients for whom ancillary services are needed,” says Fiellin.
He points out that in this study, patients who were not faring well under the study regimen were referred out to specialty opiate treatment programs. Fiellin says that in everyday practice he would like to see more handoffs occurring between primary care and specialty providers, based on an assessment of patients’ individual needs.
The latest study points out the significant impact buprenorphine’s arrival has had on the treatment of opioid dependence. It states that before buprenorphine’s introduction in 2002, fewerthan 200,000 patients in the U.S. were receiving methadone annually. In 2008 and 2009, just under 270,000 patients were receiving methadone, but more than 600,000 individuals were receiving buprenorphine.
“If buprenorphine has done anything, rather than divert patients from opiate treatment programs, it has expanded opportunities for many who might not otherwise have sought out treatment or who were not comfortable receiving methadone,” Fiellin says.