JAMA 2008;300(17):2003-2011. [doi: 10.1001/jama.2008.574]
George E. Woody, MD (University of Pennsylvania School of Medicine, DV Node), Sabrina A. Poole, MS (University of Pennsylvania School of Medicine, DV Node), Geetha A. Subramaniam, MD (Mountain Manor Treatment Center, MA Node), Karen L. Dugosh, PhD (Treatment Research Institute, DV Node), Michael P. Bogenschutz, MD (Center on Alcoholism, Substance Abuse, and Addictions (CASAA), SW Node), Patrick Abbott, MD (Addiction and Substance Abuse Programs (ASAP), SW Node), Ashwin A. Patkar, MD (Duke University Medical Center, DSC), Mark Publicker, MD (Mercy Recovery Center, NNE), Karen McCain, MSN, FNP (Duke University Medical Center, DSC), Jennifer Sharpe Potter, MPH, PhD (McLean Hospital, Harvard Medical School, NNE Node), Robert F. Forman, PhD (University of Pennsylvania School of Medicine, DV Node), Victoria Vetter, MD (Children's Hospital of Philadelphia, DV Node), Laura F. McNicholas, MD, PhD (University of Pennsylvania School of Medicine, DV Node), Jack D. Blaine, MD (Center for the Clinical Trials Network, NIDA), Kevin G. Lynch, PhD (University of Pennsylvania School of Medicine, DV Node), Paul Fudala, PhD (University of Pennsylvania School of Medicine, DV Node).
This is the Primary Outcomes Article for CTN-0010. The usual treatment for opioid-addicted youth is detoxification and counseling. However, extended medication-assisted therapy may be more helpful. National Drug Abuse Treatment Clinical Trials Network study CTN-0010 evaluated the efficacy of continuing buprenorphine-naloxone for 12 weeks versus detoxification for opioid-addicted youth. The CTN-0010 clinical trial, held at six community treatment programs from July 2003 to December 2006, included 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). 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 a day and then tapered to day 14. All were offered weekly individual and group counseling. The main outcome measure was opioid-positive urine test results at weeks 4, 8, and 12.
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. At week 4, 59 detox patients had positive results versus 58 12-week buprenorphine/naloxone patients. At week 8, 53 detox patients had positive results versus 52 12-week buprenorphine/naloxone patients. At week 12, 53 detox patients had positive results versus 49 12-week buprenorphine/naloxone patients. By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs. 52 of 74 12-week buprenorphine/naloxone patients (70%). During weeks 1 through 12, patients in the 12-week buprenorphine/naloxone group reported less opioid use, less injecting, and less nonstudy addiction treatment. 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. (Article (Peer-Reviewed), PDF, English, 2008)
Keywords: Adolescents | Buprenorphine/Naloxone | CTN primary outcomes | Opioid dependence | Opioid detoxification | Pharmacological therapy | Suboxone | Young adults | JAMA (journal)
Document No: 328, PMID: 18984887, PMCID: PMC2610690
Submitted by the CTN Dissemination Librarians, 11/5/2008.