NEW YORK (Reuters Health) – Buprenorphine-naloxone (Suboxone, Reckitt-Benckiser) helps curb prescription opioid dependence, but counseling does little to boost success rates, according to results of a randomized controlled trial published online today in Archives of General Psychiatry.

The study found that opioid-dependent patients, with or without chronic pain, are likely to reduce their opioid use during the first several months of treatment while taking buprenorphine-naloxone, but when tapered off the medication, the likelihood of relapse is “overwhelmingly high,” even in those receiving counseling in addition to standard medical management.

“While we expected that patients in the study would do significantly better while taking buprenorphine, we were somewhat surprised by how low the rate of successful outcomes was for these patients after being tapered off prescription opioids,” Dr. Roger Weiss, chief of the Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, Massachusetts and professor of psychiatry, Harvard Medical School, Boston, told Reuters Health.

“Since they had a number of characteristics that are ordinarily associated with good outcomes, the fact that less than 10% of them did well after a taper was notable,” Dr. Weiss said.

The combination of buprenorphine-naloxone has been shown helpful in heroin-dependent individuals. Abuse of prescription opioids is a significant and growing problem. It's been suggested that patients dependent on prescription opioids have “more favorable” prognostic characteristics than those dependent on heroin and at least one study found that they respond better to buprenorphine-naloxone office-based treatment.

The impact of counseling in the office-based treatment of individuals dependent on prescription opioids is unknown. To investigate, Dr. Weiss and colleagues enrolled 653 patients seeking treatment for prescription opioid dependence in a two-phase study.

The first phase (brief treatment) included buprenorphine-naloxone induction, two-week stabilization period, two-week taper period and eight-week postmedication follow up, with or without counseling given by trained substance abuse or mental health professionals.

During this phase, only 43 of 653 patients, or 6.6%, had a successful outcome, regardless of whether they received counseling or not. Successful outcome was defined as finishing week 12 with self-reported opioid use on no more than four days in a month, absence of two consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than one missing urine sample during the 12 weeks.

Patients unsuccessful in phase one entered phase two consisting of extended treatment (buprenorphine-naloxone for 12 weeks with a four-week taper and eight-week postmedication followup, with or without counseling). Success rates were much higher in phase two than phase one – 49.2% (177 of 360 patients). As in phase one, opioid dependent counseling didn't impact success rates.

Successful outcome in phase two was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least two of the previous three weeks (weeks 9-11).

However, success rates dropped to 8.6% (31 of 360) eight weeks after completing the buprenorphine-naloxone taper (phase two, week 24), again with no counseling difference.

Chronic pain did not affect opioid use outcomes, while a history of ever using heroin was associated with lower success rates in phase two (extended treatment) while taking buprenorphine-naloxone.

The current study supports the trend toward treatment of opioid dependence by physicians in office-based practice, the study team notes.

The findings suggest that “physicians can successfully treat many patients dependent on prescription opioids, with or without chronic pain, using buprenorphine-naloxone with relatively brief weekly medical management visits; half of the sample did well during this 12-week regimen,” the investigators point out.

However, it’s important to note, Dr. Weiss said, that “detoxification, without follow-up medication treatment, has a low success rate in opioid dependent patients.” Clinicians “should bear that in mind when treating this patient population,” he added.

The present findings, he and colleagues note in their paper, “raise an important question: What length of buprenorphine-naloxone treatment, if any, would lead to substantially better outcomes after a taper? This is a topic of clinical and research interest.”

Reckitt Benckiser provided the study medication but did not participate or fund the study.


Arch Gen Psych. 2011.