Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Subjective Opioid Withdrawal Scale (SOWS) scores
研究概览
简要总结
A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.
详细描述
A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal. It follows a UG3 study in which 90 inpatients with an OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with lofexidine/pregabalin or lofexidine/placebo pregabalin. Results were that the conditions were equally safe, and that lofexidine/pregabalin was more effective in reducing subjective withdrawal and keeping patients in treatment than lofexidine/placebo pregabalin.
The objectives are to study the safety and effectiveness of lofexidine/pregabalin compared to lofexidine/placebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient settings.
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)
盲法说明
double-blind placebo-controlled randomized trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female subjects ≥ 18 years of age
- •Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have met 2 or more of the 11 criteria for an OUD including tolerance and withdrawal within the last 12 months
- •Interested in opioid antagonist treatment
- •Used opioids in 20 or more of the last 30 days
- •A stable address in the local area; not planning to move in the next 60 days.
- •Have documents for ID check
- •Absence of medical or psychiatric conditions that are likely to interfere with study participation
- •Has 12 lead ECG demonstrating a QTc ≤450 msec and a QRS ≤120 msec. Site PI has final determination for study inclusion if readings exceed these limits. The PENN cardiologists and medical monitor are available for consultation when needed
- •Negative pregnancy test and using adequate contraception if of childbearing potential.
排除标准
- •Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission
- •Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
- •Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
- •Pending incarceration or plans to leave the immediate area in the next 30 days
- •Homicidal or otherwise behaviorally disturbed requiring immediate attention
- •High risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on C-SSRS
- •Blood pressure <90 mm Hg (systolic) or <60 mm Hg (diastolic). If value out of normal range, the investigator and study Clinician will decide subject inclusion/exclusion on case-by-case basis
- •Heart rate and/or pulse<50 bpm at screening-sitting
- •An Estimated Glomerular Filtration Rate eGFR<70 mL/min/1.73m2
- •A History of, or current Seizure disorder (excluding childhood febrile seizures)
- •Inability to read and/or understand English. For example, unable to understand the informed consent as demonstrated by failing to answer 9/10 questions correctly on the quiz
- •12. Pregnant or breastfeeding
- •13. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
- •ALT and/or AST >4X upper limit of normal
- •A Child-Pugh score >7
- •Currently receiving opioids for pain management
- •In a treatment study where medication was administered in the last 30 days
- •Currently using medications that are known to be strong or moderate inhibitors of CYP2D6 such as fluoxetine, paroxetine, mirabegron, bupropion, quinidine, terbinafine, cimetidine, cinacalcet, duloxetine, or fluvoxamine
- •In a methadone maintenance or buprenorphine treatment program within the last 30 days
研究组 & 干预措施
LFX/PLA-PGB
PLA-PGB/day 1-7= 0mg each day, day 8, 9, and 10 =0mg each day
LFX/ day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg
干预措施: LFX/PLA-PGB (Drug)
LFX/PGB
PGB/day 1=400mg, day 2-7=600mg each day, day 8=400mg, day 9=200mg, day 10=100mg
LFX/day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg
干预措施: LFX/PGB (Drug)
LFX/PGB
PGB/day 1=400mg, day 2-7=600mg each day, day 8=400mg, day 9=200mg, day 10=100mg
LFX/day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg
干预措施: LFX/PLA-PGB (Drug)
LFX/PLA-PGB
PLA-PGB/day 1-7= 0mg each day, day 8, 9, and 10 =0mg each day
LFX/ day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg
干预措施: LFX/PGB (Drug)
结局指标
主要结局
Subjective Opioid Withdrawal Scale (SOWS) scores
时间窗: 10 days per subject, through study completion (N=150)
Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal/30 = severe withdrawal
次要结局
- XR-NTX IM injection(upto 2 days per subject (N=150))
- Study detox completion(10 days per subject, through study completion (N=150))
研究者
Kyle Kampman
Professor, Psychiatry
University of Pennsylvania