Woody George E, Poole Sabrina A, Subramaniam Geetha, Dugosh Karen, Bogenschutz Michael, Abbott Patrick, Patkar Ashwin, Publicker Mark, McCain Karen, Potter Jennifer Sharpe, Forman Robert, Vetter Victoria, McNicholas Laura, Blaine Jack, Lynch Kevin G, Fudala Paul
Department of Psychiatry, Treatment Research Institute, University of Pennsylvania, 150 S Independence Mall W, Ste 600, Philadelphia, PA 19106, USA.
JAMA. 2008 Nov 5;300(17):2003-11. doi: 10.1001/jama.2008.574.
The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful.
To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.
DESIGN, SETTING, AND PATIENTS: 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).
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.
Opioid-positive urine test result 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 (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.
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.
clinicaltrials.gov Identifier: NCT00078130.
对阿片类药物成瘾的青少年的常规治疗是戒毒和咨询。延长药物辅助治疗可能更有帮助。
评估持续使用丁丙诺啡-纳洛酮12周与对阿片类药物成瘾青少年进行戒毒治疗的疗效。
设计、地点和患者：2003年7月至2006年12月在6个社区项目中进行的临床试验，纳入152名年龄在15至21岁的患者，他们被随机分为接受12周丁丙诺啡-纳洛酮治疗组或14天递减剂量（戒毒）组。
12周丁丙诺啡-纳洛酮组的患者在9周内每天最多服用24毫克，然后逐渐减量至第12周；戒毒组的患者每天最多服用14毫克，然后逐渐减量至第14天。所有患者均接受每周一次的个体和团体咨询。
第4、8和12周时阿片类药物尿检呈阳性的结果。
18岁以下患者数量过少，无法单独分析，但总体而言，戒毒组患者在第4周和第8周时阿片类药物尿检呈阳性的比例较高，但在第12周时并非如此（χ²(2)=4.93，P = 0.09）。在第4周，59名戒毒患者结果呈阳性（61%；95%置信区间[CI]=47%-75%），而58名接受12周丁丙诺啡-纳洛酮治疗的患者为26%（95%CI = 14%-38%）。在第8周，53名戒毒患者结果呈阳性（54%；95%CI = 38%-70%），而52名接受12周丁丙诺啡-纳洛酮治疗的患者为23%（95%CI = 11%-35%）。在第12周，53名戒毒患者结果呈阳性（51%；95%CI = 35%-67%），而49名接受12周丁丙诺啡-纳洛酮治疗的患者为43%（95%CI = 29%-57%）。到第12周时，78名戒毒患者中有16名（20.5%）仍在接受治疗，而74名接受12周丁丙诺啡-纳洛酮治疗的患者中有52名（70%；χ²(1)=32.90，P < 0.001）。在第1至12周期间，接受12周丁丙诺啡-纳洛酮治疗组的患者报告使用阿片类药物较少（χ²(1)=18.45，P < 0.001），注射较少（χ²(1)=6.00，P = 0.01），接受非研究性成瘾治疗较少（χ²(1)=25.82，P < 0.001）。随访时两组均出现高水平的阿片类药物使用情况。83名基线丙型肝炎检测呈阴性的患者中有4名在第12周时丙型肝炎检测呈阳性。
与短期戒毒相比，持续使用丁丙诺啡-纳洛酮治疗可改善治疗效果。有必要进一步研究评估丁丙诺啡长期治疗对阿片类药物依赖青少年的疗效和安全性。
clinicaltrials.gov标识符：NCT00078130。
