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Preventing Risky Drinking in Veterans Treated With Prescription Opioids

2021年12月9日 更新者:University of Pennsylvania
Veterans who are taking prescription opioids for chronic pain and are engaging in risky drinking are at heightened risk for drug interactions, including overdose and other negative effects, particularly if they are also using benzodiazepines. The investigators propose to test a prevention intervention, designed to reduce rates of risky drinking in veterans receiving prescription opioids to treat their chronic pain. This adaptive, patient-centered intervention provides clinical assessment, brief intervention, monitoring, and extended prevention services delivered through a combination of clinical visits, telephone calls, and text messages. The investigators propose to conduct a study in which veterans (N=300) who are on daily doses of prescription opioids will be randomized to receive 12 months of an adaptive prevention intervention (PI) or to standard care (SC), which consists of a Brief Intervention (BI) with 2 follow-up contacts. Potential participants will be veterans at the Philadelphia VA, and surrounding areas, or the Pittsburgh VA who, based on pharmacy records, are using opioids daily to treat chronic pain. An initial evaluation will identify individuals who also engage in risky alcohol use based on NIAAA-recommended guidelines and meet other inclusion criteria to be enrolled in the study. The evaluation will also identify the use of other medications (e.g., benzodiazepines) that could interact negatively with opioid use. For veterans randomized to the PI condition, a BI is first provided to reduce alcohol to non-hazardous levels and the effects are monitored for one month. Veterans who reduce alcohol use to non-hazardous levels during this one-month period continue in a monitoring track, consisting of tailored text messages and brief monthly telephone contacts. Veterans who continue to drink at risky levels are instead placed in a track that provides tailored text messages and more frequent telephone calls. In addition to monitoring, these calls provide further prevention/BI services to help the veteran reduce alcohol use to non-hazardous levels. Key components of these services are motivational enhancement and development of more effective ways to cope with stress and other triggers for risky alcohol use. All participants will be followed up at 3, 6, 9, 12 and 18 months after baseline. The primary outcome at each follow-up point will be a dichotomous measure of any risky drinking since the prior follow-up (yes/no). Secondary outcomes will include self-reported frequency of heavy drinking, biological measures of alcohol use, other drug use as determined by urine toxicology tests, opioid overdoses, and ratings of depression and pain. Repeated measures analyses will compare the PI and SC conditions on primary and secondary outcomes assessed across an 18-month follow-up. Analyses will also test hypothesized moderation and mediation effects.

研究概览

研究类型

介入性

注册 (实际的)

108

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Philadelphia VA Medical Center
      • Pittsburgh、Pennsylvania、美国、15261
        • VA Pittsburgh Health System

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 88年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • currently be receiving daily treatment with a prescription opioid for chronic pain;
  • be 18 years or older;
  • have a cell phone capable of receiving text messages;
  • and be willing to be in a study where they might receive text messages.

Exclusion Criteria:

  • meet DSM-V criteria for a moderate to severe alcohol or drug disorder (with the exception of nicotine abuse/dependence);
  • have a current psychotic disorder severe enough to require inpatient treatment;
  • are participating in substance abuse treatment at the VA or elsewhere (with exception of screening and brief intervention at the VA).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Standard Care
In this arm, veterans receive the care that they would receive had they not enrolled in the research. No one will receive less than standard care.
实验性的:Prevention Intervention
An adaptive monitoring intervention, delivered through text messages and brief telephone calls, that can provide extended prevention services for veterans engaging in risky alcohol use. After a veteran receives a BI for risky drinking, we will monitor alcohol use for 4 weeks. Veterans who reduce alcohol use to safe levels will be placed in a monitoring track, which consists of tailored text messages and brief monthly telephone contacts. Conversely, veterans who continue to use alcohol at hazardous levels will be placed in a track that provides tailored text messages and more frequent telephone calls. These calls provide further prevention/intervention services to help the veteran reduce alcohol use. These services address motivational issues and identify more effective ways to cope with stress and other factors that trigger unsafe alcohol use. Information on the veteran's progress is used to guide the content of subsequent text messages and prevention interventions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Rates of Risky Drinking, Week 13
大体时间:weeks 1 - 13
The primary outcome measure will be rates of the presence of any risky drinking in each week (i.e., more than 4 drinks per drinking day) as reported on the Time Line Follow Back.
weeks 1 - 13
Rates of Risky Drinking, Week 26
大体时间:weeks 14 - 26
Rates of the presence of any risky drinking in each week (14 - 26)
weeks 14 - 26
Rates of Risky Drinking, Week 39
大体时间:weeks 27 - 39
Rates of the presence of any risky drinking in each week (27 - 39)
weeks 27 - 39
Rates of Risky Drinking, Week 52
大体时间:weeks 40 - 52
Rates of the presence of any risky drinking in each week (40 - 52)
weeks 40 - 52
Rates of Risky Drinking, Week 78
大体时间:weeks 53 - 78
Rates of the presence of any risky drinking in each week (53 - 78)
weeks 53 - 78

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年4月1日

初级完成 (实际的)

2020年9月30日

研究完成 (实际的)

2020年9月30日

研究注册日期

首次提交

2016年1月28日

首先提交符合 QC 标准的

2016年3月10日

首次发布 (估计)

2016年3月16日

研究记录更新

最后更新发布 (实际的)

2022年3月2日

上次提交的符合 QC 标准的更新

2021年12月9日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 818671

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

简短干预的临床试验

3
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