According to research published early online in the Archives of General Psychiatry, patients who are dependent on prescription opioids are most likely to reduce their use during treatment with buprenorphine-naloxone.  This effect is short lived however and reduces after treatment is tapered; the likelihood of a successful outcome is therefore low, even if counselling is also given. 

The authors note that the abuse of prescription opioids is a growing public health concern; the majority of research on the treatment of this has however focused on heroin-dependent patients receiving methadone in specialised treatment programmes.  Evidence has suggested that patients dependent on prescription opioids have more favourable prognostic characteristics than do those dependent on heroin, therefore their responses to treatment may be different.

In this randomised clinical trial conducted in the US, researchers sought to evaluate the efficacy of brief and extended buprenorphine hydrochloride–naloxone hydrochloride treatment, with different counselling intensities, for patients dependent on prescription opioids (n=653).  The study consisted of two phases – Phase 1 (brief treatment) consisted of a 2-week buprenorphine-naloxone stabilisation, 2-week taper, and 8-week post-medication follow-up.   Those who were unsuccessful entered Phase 2, which involved extended (12-week) buprenorphine-naloxone treatment, 4-week taper, and 8-week post-medication follow-up.  In both Phases the participants were randomised to receive either standard medical management (SMM) or SMM plus opioid dependence counselling; all received buprenorphine-naloxone.

The main outcome was ‘successful outcome’ – a composite of measures indicating minimal or no opioid use based on urine test–confirmed self-reports.  The main results are reported:

• Only 43 patients (6.6%) had a successful outcome in Phase 1, with no difference between SMM and SMM plus opioid dependence counselling.

• A total of 177 patients (49.2%) had a successful outcome in Phase 2 during extended buprenorphine-naloxone treatment (week 12), with no difference between counselling conditions.

• The success rate in Phase 2 dropped to 8.6% (31 of 360) after buprenorphine-naloxone taper was completed (phase 2, week 24), again with no difference seen with counselling.

• Chronic pain did not affect opioid use outcomes; a history of ever using heroin was associated with lower phase 2 success rates while taking buprenorphine-naloxone.

The authors comment on their results, and how the high rate of unsuccessful outcomes after buprenorphine-naloxone taper is notable in light of the good prognostic factors of the study population (i.e. a large proportion were employed and well educated, with relatively brief histories of opioid use, and little other current substance use).  They do however note that this finding should be interpreted with caution, as the study design did not include a control group of patients who were not tapered.  They go on to comment on the lack of benefit seen for opioid dependence counselling, and say that it is not known whether their findings can be generalised to patients with severe pain or patients seeking treatment for pain rather than for opioid dependence. 

The authors conclude that their results raise an important question: ‘What length of buprenorphine-naloxone treatment, if any, would lead to substantially better outcomes after a taper?’  This needs to be addressed by subsequent research.