Early tapering of opioid-dependent patients may lead to relapse

Prescription opioid-dependent patients are highly likely to relapse if tapered off buprenorphine-naloxone, even after 12 weeks of treatment and even when receiving additional counseling, researchers found.

To evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment (Suboxone) with standard and opioid-specific counseling, researchers designed a treatment course intended to approximate clinical practice. Results appeared in the Nov. 7 Archives of General Psychiatry.

The study was a 10-site, randomized clinical trial using a two-phase adaptive treatment research design among 653 treatment-seeking outpatients dependent on prescription opioids. In each phase, patients were randomized to either standard medical management alone or standard management plus dependence counseling.

Patients with a score greater than 8 on the Clinical Opiate Withdrawal Scale received sublingual buprenorphine-naloxone for once-daily dosing at weekly visits. Patients received 4 to 12 mg (in 4-mg doses) on the induction day, depending on their initial response. At each visit, the study physician could adjust the buprenorphine-naloxone dose in increments of up to 8 mg/wk. Physicians could adjust the dose for opioid use, withdrawal symptoms, adverse effects and craving, but not for pain. The allowable dose was 8 to 32 mg/d, consistent with practice guidelines.

Half the patients were randomly assigned to receive opioid dependence counseling in addition to standard medical management. Counseling consisted of 45- to 60-minute sessions by trained substance abuse or mental health professionals. Counselors educated patients about addiction and recovery, recommended self-help groups, and emphasized lifestyle change. Counseling covered a wider range of relapse prevention issues in greater depth than did standard medical management, including coping with high-risk situations, managing emotions and dealing with relationships.

Brief treatment (phase 1) consisted of buprenorphine-naloxone induction, two weeks of stabilization, a two-week taper, and eight weeks of follow-up. Patients who met the “successful outcome” criteria at week 12 exited the study. The definition of “successful outcome” was based on composite measures indicating minimal or no opioid use based on urine test-confirmed self-reports.

Unsuccessful patients entered into extended treatment (phase 2), which consisted of 12 weeks of buprenorphine-naloxone stabilization, a four-week taper, and eight weeks of follow-up.

During phase 1, only 6.6% (43 of 653) of patients had successful outcomes, with no difference between standard management and opioid counseling. In phase 2, 49.2% (177 of 360) attained successful outcomes during extended buprenorphine-naloxone treatment (week 12), with no difference between groups. Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no difference associated with counseling.

In secondary analyses, successful phase 2 outcomes were more common while taking buprenorphine-naloxone than 8 weeks after taper (49.2% [177 of 360] vs. 8.6% [31 of 360], P<0.001). Chronic pain did not affect opioid use outcomes, and a history of ever using heroin was associated with lower phase 2 success rates.

The authors wrote, “The present 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 authors continued that the study supports the national trend toward office-based treatment of opioid dependence. Patients dependent on prescription opioids, with or without chronic pain, are most likely to reduce their opioid use during the first several months of treatment while receiving buprenorphine-naloxone. Tapering creates an overwhelmingly high risk of relapse or dropout from treatment, they concluded.