一项在刑事司法系统中针对阿片类药物依赖女性的丁丙诺啡随机对照试验的初步结果。
Results of a pilot randomized controlled trial of buprenorphine for opioid dependent women in the criminal justice system.
机构信息
University of Alabama at Birmingham, Department of Psychiatry, 401 Beacon Parkway West, Birmingham, AL 35209, USA.
出版信息
Drug Alcohol Depend. 2011 Dec 15;119(3):172-8. doi: 10.1016/j.drugalcdep.2011.06.021. Epub 2011 Jul 23.
AIMS
Recent studies have demonstrated the efficacy of both methadone and buprenorphine when used with opioid dependent men transitioning from prison to the community, but no studies have been conducted with women in the criminal justice (CJ) system. The aim of this study was to determine the efficacy of buprenorphine for relapse prevention among opioid dependent women in the CJ system transitioning back to the community.
METHODS
36 women under CJ supervision were recruited from an inpatient drug treatment facility that treats CJ individuals returning back to the community. Nine were enrolled in an open label buprenorphine arm then 27 were randomized to buprenorphine (n=15) or placebo (n=12; double-blind). All women completed baseline measures and started study medication prior to release. Participants were followed weekly, provided urine drug screens (UDS), received study medication for 12 weeks, and returned for a 3-month follow-up. Intent-to-treat analyses were performed for all time points through 3 month follow-up.
RESULTS
The majority of participants were Caucasian (88.9%), young (M±SD=31.8±8.4 years), divorced/separated (59.2%) women with at least a high school/GED education (M±SD=12±1.7 years). GEE analyses showed that buprenorphine was efficacious in maintaining abstinence across time compared to placebo. At end of treatment, 92% of placebo and 33% of active medication participants were positive for opiates on urine drug screen (Chi-Square=10.9, df=1; p<0.001). However, by the three month follow-up point, no differences were found between the two groups, with 83% of participants at follow-up positive for opiates.
CONCLUSIONS
Women in the CJ system who received buprenorphine prior to release from a treatment facility had fewer opiate positive UDS through the 12 weeks of treatment compared to women receiving placebo. Initiating buprenorphine in a controlled environment prior to release appears to be a viable strategy to reduce opiate use when transitioning back to the community.
目的
最近的研究表明，美沙酮和丁丙诺啡在帮助从监狱过渡到社区的阿片类药物依赖男性方面都具有疗效，但没有针对刑事司法（CJ）系统中的女性进行的研究。本研究旨在确定丁丙诺啡对从监狱返回到社区的 CJ 系统中阿片类药物依赖女性预防复发的效果。
方法
从一家治疗返回社区的 CJ 个体的住院药物治疗机构中招募了 36 名受到 CJ 监管的女性。9 名女性参加了开放性丁丙诺啡试验，然后 27 名女性被随机分配到丁丙诺啡组（n=15）或安慰剂组（n=12；双盲）。所有女性在释放前完成基线测量并开始服用研究药物。参与者每周接受一次随访，进行尿液药物筛查（UDS），接受 12 周的研究药物治疗，并在 3 个月时进行随访。对所有时间点进行意向治疗分析，直至 3 个月随访。
结果
大多数参与者为白人（88.9%），年龄较小（M±SD=31.8±8.4 岁），离异/分居（59.2%），至少受过高中/普通教育（M±SD=12±1.7 年）。GEE 分析显示，与安慰剂相比，丁丙诺啡在维持时间上的戒断效果更有效。治疗结束时，安慰剂组和活性药物组分别有 92%和 33%的参与者尿液药物筛查呈阿片类阳性（卡方=10.9，df=1；p<0.001）。然而，在 3 个月随访点，两组之间没有发现差异，83%的参与者在随访时阿片类阳性。
结论
从治疗机构释放前接受丁丙诺啡的 CJ 系统中的女性在接受治疗的 12 周内，尿液药物筛查呈阿片类阳性的次数少于接受安慰剂的女性。在返回到社区之前，在受控环境中开始使用丁丙诺啡似乎是一种减少阿片类药物使用的可行策略。
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