Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD: A Pilot Double-blind, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks
研究概览
简要总结
The investigators propose to test the use of pramipexole in patients being treated for Opioid Use Disorder to test its ability to reduce symptoms of both Restless Legs Syndrome and protracted opioid withdrawal and thereby promote initiation, engagement, and retention in treatment.
详细描述
This is a parallel, two-arm, double-blind, randomized placebo-controlled 2-week trial investigating the effects of pramipexole 0.25-0.5 mg on Restless Legs Syndrome (RLS) symptoms in patients suffering from opioid withdrawal. The investigators hypothesize that pramipexole is an effective treatment for RLS symptoms in Opioid Use Disorder (OUD) patients during post-detox clinical stabilization. Further, the investigators hypothesize that treatment of RLS in this context will also improve overall symptoms of opioid withdrawal.
RLS is a sensory-motor neurological disorder characterized by an irresistible urge to move the legs. The investigators have recently confirmed anecdotal reports that RLS is common among patients with OUD experiencing opioid withdrawal. Dopamine agonists such as pramipexole are efficacious and first-line FDA-approved treatments in low doses for RLS.
Recruitment and enrollment will occur at the Gavin Foundation Clinical Stabilization Services (CSS) in Quincy, Massachusetts. Eligible patients will be randomized to two weeks of pramipexole or placebo after an initial 3-day screening period and will be asked to complete 5 remote study visits over video or phone. Participants will be asked to complete sleep diaries and questionnaires at various points throughout the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of any ethnic origin.
- •Written informed consent is obtained
- •Speaks and writes in English
- •A willingness and ability to comply with study procedures.
- •Age 18-75 years
- •Patients with diagnosed OUD who have undergone primary detoxification for their OUD in the Gavin Acute Treatment Service (ATS), have been transferred to the Gavin Clinical Stabilization Service (CSS), and have some persistent opioid withdrawal as indicated by a Subjective Opiate Withdrawal Scale (SOWS) >1 on Day 1
- •Diagnosis of RLS from the Hening Telephone Diagnostic Interview (HTDI) with subsequent confirmation by clinical interview conducted by a study physician
- •International Restless Legs Syndrome Severity Scale (IRLS) Symptoms subscale score of >15 for three consecutive days prior to randomization
排除标准
- •Receiving opioid-agonist medications at transfer to the CSS
- •Participants with active or unstable major psychiatric disorder other than OUD, who, in the investigators' judgment, require further treatment
- •Use of dopaminergic agonists or antagonists within the last 30 days
- •Alcohol use disorder within the last 30 days
- •History of being treated for RLS, specifically with dopamine agonist medications
- •Methamphetamine or benzodiazepine dependence in the last 30 days
- •Neurological disorder or cardiovascular disease raising safety concerns about use of pramipexole and/or judged to interfere with ability to assess efficacy of the treatment
- •Medical instability considered to interfere with study procedures
- •Stage 3, 4, or 5 renal insufficiency
- •Participation in this study on a previous admission to the CSS
研究组 & 干预措施
Pramipexole
Medication arm; 0.25 of pramipexole
干预措施: Pramipexole (Drug)
Placebo
Placebo arm; 0.25 mg of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks
时间窗: baseline and 2 weeks
The International Restless Legs Syndrome Study Group Rating Scale (IRLS) is a 10-item patient-reported questionnaire designed to assess the severity of restless legs syndrome symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe), for a total score range of 0 to 40, with higher scores indicating greater symptom severity. A negative change from baseline represents symptom improvement. Very severe=31-40 points Severe=21-30 points Moderate=11-20 points Mild=1-10 points None=0 points Change 2 weeks IRLS score minus baseline IRLS score
次要结局
- Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks(baseline and 2 weeks)
研究者
John Winkelman, MD, PhD
Chief, Sleep Disorders Clinical Research Program
Massachusetts General Hospital