A randomized controlled trial of buprenorphine taper duration among opioid-dependent adolescents and young adults

A randomized controlled trial of buprenorphine taper duration among opioid-dependent adolescents and young adults
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DOI:
10.1111/add.13363
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发表时间:
2016-08-01
期刊:
影响因子:
6
通讯作者:
Ducat, Elizabeth
Ducat, Elizabeth
中科院分区:
医学1区
文献类型:
--
作者:
Marsch, Lisa A.;Moore, Sarah K.;Ducat, Elizabeth

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背景和目的很少有随机对照试验评估丁丙诺啡治疗对阿片类药物依赖青年的干预措施。因此,该队列的最佳管理策略尚不清楚。我们的目的是评估两种不同丁丙诺啡减少长度在促进阿片类药物依赖青少年戒断非法阿片类药物和治疗保留方面的相对功效。设计一项双盲、安慰剂对照、多中心随机对照试验。2005年至2010年,在美国纽约市设立了两个以医院为基础的研究诊所(曼哈顿和布鲁克林)。参与者:53名符合DSM-IV阿片类药物依赖标准的16 - 24岁主要为白种人的志愿者样本(n=11名18岁以下)。干预:通过平行组设计,参与者被随机分配到28天丁丙诺啡逐渐减少(n=28)或56天丁丙诺啡逐渐减少(n=25),为期63天。两组都接受了行为咨询和阿片类药物戒断奖励。两种减量条件在减量结束时都至少有1周的安慰剂剂量。测量主要结果是阿片类药物戒断,以阿片类药物阴性尿毒理学测试记录的百分比来测量。次要结果是治疗保留,以参加预定就诊的天数来衡量。研究结果显示,接受56天丁丙诺啡逐渐减少治疗的参与者与接受28天丁丙诺啡逐渐减少治疗的参与者相比,阿片类药物阴性排定尿检的百分比显着更高[35%对17%,P=0.039;Cohen’s d=0.57, 95%可信区间(CI)=0.02, 1.13]。接受56天丁丙诺啡逐渐减少治疗的参与者比接受28天丁丙诺啡逐渐减少治疗的参与者在治疗中保留的时间明显更长(37.5天对26.4天,P=0.027; Cohen’s d=0.63, 95% CI=0.06, 1.19)。与每周2 - 3次的出勤要求相比,每日出勤要求与减少戒断和更短的保留有关,与逐渐减少的持续时间无关。随访资料不足,无法报道。结论对于阿片类药物依赖的青少年,较长(56天)丁丙诺啡逐渐减少比较短(28天)丁丙诺啡逐渐减少具有更好的阿片类药物戒断和滞留效果。
Background and AimsFew randomized controlled trials have evaluated buprenorphine treatment interventions for opioid-dependent youth. Consequently, optimal administration strategies for this cohort are unclear. Our aim was to evaluate the relative efficacy of two different buprenorphine taper lengths in promoting abstinence from illicit opioids and treatment retention among opioid-dependent youth.DesignA double-blind, placebo controlled, multicenter randomized controlled trial.SettingTwo hospital-based research clinics (Manhattan and Brooklyn) in New York City, USA from 2005 to 2010.ParticipantsVolunteer sample of 53 primarily Caucasian participants between the ages of 16 and 24 (n=11 under age 18) who met DSM-IV opioid dependence criteria.InterventionParticipants were assigned randomly to either a 28-day buprenorphine taper (n=28) or 56-day buprenorphine taper (n=25) via a parallel-groups design during a 63-day period. Both groups received behavioral counseling and opioid abstinence incentives. Both taper conditions had a minimum of 1week of placebo dosing at the end of the taper.MeasurementsThe primary outcome was opioid abstinence measured as a percentage of scheduled urine toxicology tests documented to be negative for opioids. The secondary outcome was treatment retention, measured as number of days attended scheduled visits.FindingsIntent-to-treat analyses revealed that participants who received a 56-day buprenorphine taper had a significantly higher percentage of opioid-negative scheduled urine tests compared with participants who received a 28-day buprenorphine taper [35 versus 17%, P=0.039; Cohen's d=0.57, 95% confidence interval (CI)=0.02, 1.13]. Participants who received a 56-day buprenorphine taper were retained in treatment significantly longer than participants who received a 28-day buprenorphine taper (37.5 versus 26.4days, P=0.027; Cohen's d=0.63, 95% CI=0.06, 1.19). Daily attendance requirement was associated with decreased abstinence and shorter retention compared with a two to three times weekly attendance requirement, independent of taper duration. Follow-up data were insufficient to report.ConclusionLonger (56-day) buprenorphine taper produces better opioid abstinence and retention outcomes than shorter (28-day) buprenorphine taper for opioid-dependent youth.