SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Talaria, Inc
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which uses the text messaging and internet capabilities of modern cellular phones to address the problem of medication adherence in clinical care and clinical trial contexts. This trial will evaluate whether AGATE improves medication adherence in the context of a pharmacotherapy trial of naltrexone to treat problem drinking. All participants will be treatment-seeking problem drinkers who will receive naltrexone and medication monitoring over 8 weeks.
详细描述
The purpose of the naltrexone trial is to evaluate whether AGATE effectively measures and enhances medication adherence in the context of naltrexone treatment for problem drinking. Participants will be heavy/problem drinkers, recruited from the greater Albuquerque area, who are interested in either reducing or stopping their drinking and deemed to be candidates for naltrexone pharmacotherapy by the study psychiatrist, Dr. Arenella. All participants will be prescribed naltrexone, 50 mg, once daily, for eight weeks, and receive smartphones. Participants will be randomly assigned to receive either AGATE or SASED, a web-based alcohol and side-effects diary via smartphone. The primary outcome will be percent of scheduled doses that were taken during the eight week trial, as measured by the Medication Event Monitoring System (MEMS, Aardex Group, Union City, CA), pill counts, and using the timeline follow-back (TLFB) method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •problem or heavy drinkers
- •age 21-55 years old
- •located in the greater Albuquerque NM area
- •interested in either reducing or stopping their drinking
- •candidates for naltrexone pharmacotherapy
排除标准
- •participation in other naltrexone study
- •unable to operate a smartphone
- •significant psychiatric or physical illness
- •current drug dependence
- •current regular opioid use
- •any recent nonmedical opioid use
- •any lifetime opioid dependence
研究组 & 干预措施
AGATE
To evaluate whether AGATE, a smartphone medication reminder and assessment system, effectively measures and enhances medication adherence in the context of naltrexone treatment for problem drinking.
干预措施: AGATE (Other)
SASED
The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).
干预措施: SASED (Other)
结局指标
主要结局
Medication adherence
时间窗: 8 weeks
Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
次要结局
- Indices of alcohol use, craving, etc.(8 weeks)