Evaluating a Novel Medication Device for Methadone Dosing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Participant acceptance of the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
研究概览
简要总结
This study will evaluate whether a commercially available, secure, electronic pill box is a feasible, acceptable, and satisfactory method to manage take-home dosing of methadone for both methadone clinic patients and staff members.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Receiving methadone for the treatment of opioid use disorder for at least 90 days and having been on the same methadone dose for at least 30 days
- •Have previously received a take-home dose of methadone as part of routine care
- •Be willing to comply with the study schedule
- •Be a methadone patient in the clinic within which this study is being conducted
排除标准
- •Pregnancy
- •Presence of an acute medical problems that requires immediate or intense medical management
- •Presence of serious or unstable mental illness that interferes with study procedures
- •Planning to leave methadone treatment within the next 12 weeks
- •Being maintained on a dose of methadone that is less than 10mg or more than 100mg
- •Currently receiving split doses of methadone as part of routine care
研究组 & 干预措施
Treatment-as-Usual
Participants will routine methadone clinic care.
干预措施: Take-home Dosing Procedures (Behavioral)
Take-home Dosing using MedMinder "Jon" Electronic Pill Box
Participants will receive 50% of their methadone dose in the morning in the clinic and 50% of their dose will be dispensed in an electronic pill box for participants to take at home later that day.
干预措施: Take-home Dosing Procedures (Behavioral)
Choice Phase
Participants will be allowed to select one final Treatment-As-Usual or the MedMinder "Jon" Electronic Pill Box for the final phase of the study.
干预措施: Take-home Dosing Procedures (Behavioral)
结局指标
主要结局
Participant acceptance of the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
时间窗: Week 9
Percent of participants who select the Electronic Pill Box during their Choice phase (phase 3)
Participant willingness to use the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
时间窗: Week 12
Feasibility will be assessed by conducting a survival analysis of participant retention in the study
Change in participant satisfaction
时间窗: Week 8
Participant satisfaction will be assessed using the Client Satisfaction Questionnaire- an 8-item self-report measure on which patients will rate their satisfaction with treatment on a 4-item Likert scale. Values will be summed for a total satisfaction rating (range 8-32), with higher scores indicating greater satisfaction. Participants will complete the CSQ at week 4 and week 8, and the CSQ ratings from the treatment-as-usual will be subtracted from the ratings following the MedMinder "Jon" electronic pillbox phase as a measure of change in participant satisfaction.
Change in participant satisfaction
时间窗: Week 4
Participant satisfaction will be assessed using the Client Satisfaction Questionnaire- an 8-item self-report measure on which patients will rate their satisfaction with treatment on a 4-item Likert scale. Values will be summed for a total satisfaction rating (range 8-32), with higher scores indicating greater satisfaction. Participants will complete the CSQ at week 4 and week 8, and the CSQ ratings from the treatment-as-usual will be subtracted from the ratings following the MedMinder "Jon" electronic pillbox phase as a measure of change in participant satisfaction.
次要结局
未报告次要终点