Pilot Randomized Trial of Opioid Taper Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- mean daily opioid dose over past week
研究概览
简要总结
The proposed research will develop, demonstrate the feasibility of, and pilot test in a randomized controlled trial a prescription opioid taper support intervention. This intervention aims to prevent opioid misuse and adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain without evidence of current substance abuse.
The project will yield information essential to planning a future, larger-scale RCT designed to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse, misuse, overdose and other adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related activity interference, and mood. Participants in our pilot study will be limited to those without current opioid abuse or other substance abuse, but past substance abuse will be allowed. This will provide a sample of patients at risk for opioid abuse, misuse and overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid taper support intervention, as compared with patients randomized to usual opioid prescribing care, will have lower opioid average daily doses at 22 and 34 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years;
- •CNCP, defined as pain on more than half the days in the past six months, where indicated diagnostic workup is complete and treatment is focused on pain;
- •currently on COT, defined as self-report of prescribed oral opioid medication use on a daily or near-daily (>90% of days) basis for 90 days or more;
- •mean daily opioid dose in the past 30 days of 25 mg MED or greater;
- •willing to participate in the study arm to which they are randomly assigned (including opioid taper in-person sessions if randomized to that group);
- •able to read, speak, and write English.
排除标准
- •currently receiving treatment for cancer (other than non-melanoma skin cancer);
- •medical comorbidity with life expectancy less than a year (based on medical record review by the PI);
- •recent use (past month) of parenteral, transdermal, or transmucosal opioids,
- •currently residing in nursing home;
- •currently using intrathecal pump for pain control;
- •any current substance abuse according to the DSM-IV checklist (nicotine and marijuana will be allowed since Washington State allows medical marijuana for pain control);
- •presence of illicit drug metabolite in baseline urine drug test,
- •psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year;
- •current suicidal ideation with specific plan or intent;
- •significant cognitive impairment (on 6-item screener Scale).
结局指标
主要结局
mean daily opioid dose over past week
时间窗: week 22 after randomization
mean daily opioid dose over past week as calculated in morphine equivalent dose
次要结局
- prescription opioid difficulties(week 22 after randomization)
研究者
Mark Sullivan
Prinicipal Study Investigator
University of Washington