激励性依从性和禁欲监测在丁丙诺啡维持治疗中的效果：一项实用、随机对照试验。

Effectiveness of incentivised adherence and abstinence monitoring in buprenorphine maintenance: a pragmatic, randomised controlled trial.

机构信息

National Rehabilitation Centre, Abu Dhabi, United Arab Emirates.

Addictions Department, Division of Academic Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.

出版信息

Addiction. 2021 Sep;116(9):2398-2408. doi: 10.1111/add.15394. Epub 2021 Jan 28.

DOI:10.1111/add.15394

PMID:33404141

Abstract

BACKGROUND AND AIM

Buprenorphine (BUP) maintenance treatment for opioid use disorder (OUD) begins with supervised daily dosing. We estimated the clinical effectiveness of a novel incentivised medication adherence and abstinence monitoring protocol in BUP maintenance to enable contingent access to increasing take-home medication supplies.

DESIGN

Two-arm, single-centre, pragmatic, randomised controlled trial of outpatient BUP maintenance, with during-treatment follow-ups at 4 weeks, 8 weeks, 12 weeks and 16 weeks.

SETTING

Inpatient and outpatient addictions treatment centre in the United Arab Emirates.

PARTICIPANTS

Adults with OUD, voluntarily seeking treatment.

INTERVENTIONS

The experimental condition was 16 weeks BUP maintenance with incentivised adherence and abstinence monitoring (I-AAM) giving contingent access to 7-day, then 14-day, then 21-day and 28-day medication supply. The control, treatment-as-usual (TAU) was 16 weeks BUP maintenance, with contingent access to 7-day then 14-day supply.

MEASUREMENTS

The primary outcome was number of negative urine drug screens (UDS) for opioids, with non-attendance or otherwise missed UDS, imputed as positive for opioids. The secondary outcome was retention in treatment (continuous enrolment to the 16-week endpoint).

FINDINGS

Of 182 patients screened, 171 were enrolled and 141 were randomly assigned to I-AAM (70 [49.6%]) and to TAU (71 [50.4%]. Follow-up rates at 4 weeks, 8 weeks, 12 weeks and 16 weeks were 91.4%, 85.7%, 71.0%, 60.0% respectively in I-AAM and 84.5%, 83.1%, 69.0%, 56.3% in TAU. By intention-to-treat, the absolute difference in percentage negative UDS for opioids was 76.7% (SD = 25.0%) in I-AAM versus 63.5% (SD = 34.7%) in TAU (mean difference = 13.3%; 95% CI = 3.2%-23.3%; Cohen's d = 0.44; 95% CI = 0.10-0.87). In I-AAM, 40 participants (57.1%) were retained versus 33 (46.4%) in TAU (odds ratio = 1.54; 95% CI = 0.79-2.98).

CONCLUSIONS

Buprenorphine maintenance with incentivised therapeutic drug monitoring to enable contingent access to increasing take-home medication supplies increased abstinence from opioids compared with buprenorphine maintenance treatment-as-usual, but it did not appear to increase treatment retention.

摘要

背景和目的

丁丙诺啡（BUP）维持治疗阿片类药物使用障碍（OUD）始于每日监督剂量。我们估计了一种新的激励药物依从性和禁欲监测方案在 BUP 维持治疗中的临床效果，以使患者能够获得递增的居家药物供应。

设计

在阿拉伯联合酋长国的一个门诊 BUP 维持治疗中心，进行了一项两臂、单中心、实用、随机对照试验，在治疗期间，每 4 周、8 周、12 周和 16 周进行一次随访。

参与者

寻求治疗的 OUD 成年患者，自愿参加。

干预措施

实验组为 16 周 BUP 维持治疗，激励性药物依从性和禁欲监测（I-AAM）使患者获得递增的 7 天、14 天、21 天和 28 天药物供应。对照组为 16 周 BUP 维持治疗，具有递增的 7 天和 14 天的供应。

测量

主要结局是阿片类药物阴性尿液药物检测（UDS）的数量，非就诊或其他漏检 UDS，被推断为阿片类药物阳性。次要结局是治疗保留率（连续入组至 16 周终点）。

结果

在 182 名接受筛查的患者中，有 171 名患者入组，141 名患者被随机分配至 I-AAM（70 名[49.6%]）和 TAU（71 名[50.4%]）。4 周、8 周、12 周和 16 周的随访率分别为 I-AAM 组的 91.4%、85.7%、71.0%和 60.0%，TAU 组的 84.5%、83.1%、69.0%和 56.3%。按意向治疗分析，I-AAM 组阿片类药物阴性 UDS 的百分比绝对差异为 76.7%（SD=25.0%），TAU 组为 63.5%（SD=34.7%）（平均差异=13.3%；95%CI=3.2%-23.3%；Cohen's d=0.44；95%CI=0.10-0.87）。在 I-AAM 组中，有 40 名参与者（57.1%）保留，而 TAU 组有 33 名参与者（46.4%）保留（比值比=1.54；95%CI=0.79-2.98）。