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HIV 患者酒精使用障碍的标签外药物:试点研究 2 (HARP)

2026年11月3日 更新者:Yale University

标签外药物治疗 HIV 患者酒精使用障碍的可行性、可接受性和初步疗效:一项开放标签试点研究

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

研究概览

详细说明

This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol. In addition, participants will be offered varenicline in the first pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.

研究类型

介入性

注册 (实际的)

3

阶段

  • 阶段2

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

    • Georgia
      • Decatur、Georgia、美国、30033
        • Atlanta VA Medical Center

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 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • diagnosed with HIV
  • Receive care at the Atlanta VA Healthcare System
  • Are age 18 or over
  • Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen
  • Have evidence of significant alcohol use: PEth > 20ng/ml
  • Currently smoking cigarettes
  • Prescribed >=5 medications
  • Have cell phone or reliable contact number
  • Can provide written informed consent

Exclusion Criteria:

  • Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
  • Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
  • Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment
  • Untreated moderate to severe opioid use disorder
  • Residence out of state
  • Inability to read or understand English
  • History of serious hypersensitivity or adverse reaction to study medication
  • Taking potentially interactive medication(s) (e.g. nicotine replacement therapy for varenicline pilot study)
  • Already prescribed the pilot medication at the time of study recruitment

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:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Varenicline

Participants will receive a prescription for generic varenicline

All participants will receive a prescription for varenicline and will meet with a clinical pharmacist and addiction psychiatrist for further support

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
Proportion of participants who complete enrollment and duration of sessions
大体时间:12 weeks

Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study

12 weeks
Number of sessions completed
大体时间:12 weeks

Number of sessions completed to assess acceptability of study

12 weeks
Adherence to Medication
大体时间:12 weeks

Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study

12 weeks
Safety of study assessed by adverse events reporting
大体时间:12 weeks

Safety will be assessed by the percentage of study participants who report adverse events

12 weeks

次要结果测量

结果测量
措施说明
大体时间
Efficacy of study - change in self-reported alcohol use
大体时间:12 weeks

Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.

12 weeks
Efficacy of study - change in PEth (phosphatidylethanol) results
大体时间:12 weeks

PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.

12 weeks

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。

调查人员

  • 首席研究员:E. Jennifer Edelman, MD, MHS、Yale University

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)

2025年6月16日

初级完成 (实际的)

2026年8月5日

研究完成 (实际的)

2026年8月5日

研究注册日期

首次提交

2023年8月16日

首先提交符合 QC 标准的

2023年8月16日

首次发布 (实际的)

2023年8月23日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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