Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.
BACKGROUND
The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful.


OBJECTIVE
To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.


METHODS
Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox).


METHODS
Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling.


METHODS
Opioid-positive urine test result at weeks 4, 8, and 12.


RESULTS
The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12.


CONCLUSIONS
Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence.


BACKGROUND
clinicaltrials.gov Identifier: NCT00078130.
Woody
George E
GE
Department of Psychiatry, Treatment Research Institute, University of Pennsylvania, 150 S Independence Mall W, Ste 600, Philadelphia, PA 19106, USA. woody@tresearch.org
Poole
Sabrina A
SA
Subramaniam
Geetha
G
Dugosh
Karen
K
Bogenschutz
Michael
M
Abbott
Patrick
P
Patkar
Ashwin
A
Publicker
Mark
M
McCain
Karen
K
Potter
Jennifer Sharpe
JS
Forman
Robert
R
Vetter
Victoria
V
McNicholas
Laura
L
Blaine
Jack
J
Lynch
Kevin G
KG
Fudala
Paul
P
D000293:Adolescent; D000328:Adult; D002047:Buprenorphine / Q000008:administration & dosage*; D000069479:Buprenorphine, Naloxone Drug Combination; D003376:Counseling; D005260:Female; D006801:Humans; D008297:Male; D009270:Naloxone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation*; D015813:Substance Abuse Detection
D000069479:Buprenorphine, Naloxone Drug Combination; D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine