A 12-week course of continuous treatment with buprenorphine-naloxone and
counseling is more effective than conventional detoxification and counseling
in treating youth for opioid addiction, a randomized clinical trial has
From July 2003 to December 2005, 152 youth aged 15 to 21 who received
outpatient addiction treatment at six programs (four methadone programs and
two substance treatment programs for adolescents) were randomly assigned to
two groups: One group underwent outpatient detoxification for two weeks, with
a maximum dose of 14 mg/day buprenorphine (n=78); the other group received
buprenorphine-naloxone with a maximum buprenorphine dose of 24 mg/day for five
to seven days a week for 12 weeks
All patients met DSM-IV criteria for opioid dependence with
physiological features. In addition to the medication treatment, every
participant was provided with weekly counseling, including one individual
session and one group session a week, for the 12-week period.
At week 4, 61 percent of patients in the detoxification group and 26
percent of patients in the 12-week-treatment group tested positive for opioids
(see chart). By week 8, 54 percent in the detoxification group and 23 percent
in the 12-week-treatment group had opioid-positive urine tests. The difference
was statistically significant at both time points. At week 12, the percentage
of patients who tested positive was 51 percent in the detox group and 43
percent in the 12-week treatment group; the difference was not significantly
In an interview with Psychiatric News, the study's lead author
George Woody, M.D., a professor of psychiatry at the University of
Pennsylvania and the Treatment Research Institute in Philadelphia, explained
that the lack of statistical significance at week 12 may be attributable to
the fact that the dosage of buprenorphine-naltrexone was tapered off from week
9 to week 12.
The 12-week buprenorphine-naloxone treatment group had a much higher
retention rate than did the outpatient detox group. By the end of week 12, 15
of the detox patients (20.5 percent) were still in treatment, compared with 52
(70 percent) in the 12-week-treatment group.
In addition to the primary endpoints, self-reported opioid use, marijuana
use, self-injection behavior, and enrollment in other addiction
treatments were all significantly more common in the detoxification group than
the 12-week-treatment group. At six, nine, and 12 months, patients in the
detox group continued to have significantly higher proportions of positive
urine test results than those in the 12-week-treatment group.
No serious adverse events related to buprenorphine-naloxone were reported
in the study, and no one was removed from the study because of adverse
The study results suggest that clinicians "should not be in a hurry
to take patients off the medication just because they are young and have not
been addicted for a long time," according to Woody.
"These data can help change the current guidelines," he said.
For underage patients with opioid addiction, "the field has been
primarily using psychosocial treatment alone following detoxification,"
he noted. "The study shows that you can improve results if you are
willing to use medications in outpatient treatment. And that can be
The study results were published in the November 5 Journal of the American
Medical Association. The research was funded by the National Institute on
Drug Abuse. The manufacturer of buprenorphine-naloxone (Suboxone), Reckitt
Benckiser, provided the medication for the study.
An abstract of "Extended vs. Short-term Buprenorphine-Naloxone
for Treatment of Opioid-Addicted Youth: A Randomized Trial" is posted at<jama.ama-assn.org/cgi/content/abstract/300/17/2003>.▪