Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score
研究概览
简要总结
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective effects, and investigate, whether the PGB/LFX combination can increase the proportion of patients with an opioid use disorder (OUD) who complete detoxification and transition to antagonist treatment with extended-release injectable naltrexone (XR-NTX).
详细描述
An inpatient detoxification study where pregabalin (PBG) will be given orally at a starting dose of up to 600 mg daily (group 1) tapered to 100 mg daily over 7 days; given with lofexidine (LFX) starting at 2.16 mg daily and declining to 0.72 mg over 7 days. On day 8, subjects are offered an injection of XR-NTX if they provide a urine sample that is negative for opioids and buprenorphine and pass a naloxone challenge. All subjects, regardless of whether or not they receive XR-NTX, will be given a referral and appointment for follow-up treatment when they leave the inpatient detoxification program.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Penn Investigational Drug Service (IDS) will prepare blinded pregabalin capsules by over encapsulation of the drug into capsules shells matching the placebo capsules. Blinded pregabalin capsules will be packaged into blister packs along with lofexidine tablets, in separate compartments that are labeled for dosing times on days 1-7 and ship them to the research sites.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 2 or more of the 11 DSM 5 criteria for opioid disorder including tolerance and withdrawal features in the last 12 months
- •Interested in opioid antagonist treatment
- •Have used opioids in 20 or more of the last 30 days
- •Have a stable address in the local area; not planning to move; have documents for ID check
- •Absence of medical or psychiatric conditions that are likely to interfere with study participation
- •Have a 12 lead ECG demonstrating a QTc ≤450 msec and a QRS interval ≤120 msec. The site PI has the final determination for inclusion into the study for ECGs unless there is a question of QT prolongation or other factors (QTc/Fre uses the Frederica formula (QTc = QT/RR(1/3)). If consultation is needed, the PENN cardiologists and the medical monitor should be contacted
- •If female, have a negative pregnancy test and uses adequate contraception if of childbearing potential
排除标准
- •Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the MINI
- •An alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
- •History of allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
- •Pending incarceration 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 at screening
- •Blood pressure <90 mm Hg (systolic) or <60 mm Hg (diastolic). If this value is out of normal range, the investigator and a study clinician will decide subject inclusion or exclusion on a case-by-case basis
- •Heart rate and/or pulse<50 bpm at screening-sitting
- •An Estimated Glomerular Filtration Rate eGFR<90 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
- •Pregnant or breastfeeding
- •Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
- •An ALT and/or AST test that is at >4X the top 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
Lofexidine and PLACEBO
0.54 mg lofexidine and Placebo (PLB) on days 1-7 with taper for lofexidine starting on day 5
干预措施: Placebo oral tablet (Drug)
PGB/LFX;
0.54 mg lofexidine and 200 mg Pregabalin on days 1 -7 with taper for pregabalin and lofexidine starting on day 5
干预措施: Pregabalin 200 MG capsules (Drug)
PGB/LFX;
0.54 mg lofexidine and 200 mg Pregabalin on days 1 -7 with taper for pregabalin and lofexidine starting on day 5
干预措施: Lofexidine 0.18Mg Tab (Drug)
Lofexidine and PLACEBO
0.54 mg lofexidine and Placebo (PLB) on days 1-7 with taper for lofexidine starting on day 5
干预措施: Lofexidine 0.18Mg Tab (Drug)
结局指标
主要结局
Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score
时间窗: 7 days
mild = 1-10 moderate=11-20 severe=21-30 higher number equals worse score
次要结局
- Completion of Withdrawal Management(7 days)
研究者
Kyle Kampman
Professor Psychiatry
University of Pennsylvania