A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Effectiveness of LUCEMYRA in the Treatment of Opioid Withdrawal During an Opioid Taper in Subjects With Chronic Non-Cancer Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 12
- 主要终点
- Number of Treatment Emergent AEs and SAEs
研究概览
简要总结
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
详细描述
This randomized, double-blind, placebo-controlled pilot study will evaluate the safety and effectiveness of LUCEMYRA in the treatment of opioid withdrawal during an opioid taper in subjects with chronic non-cancer pain.
Subjects will begin a planned 14-day complete taper of their pre-study opioid medications and will be randomly assigned (1:1) to either LUCEMYRA or matching placebo. Study drug will be administered through the opioid taper and for 5 days after the opioid taper is completed. Study drug will then be tapered over a 4-day period for a total of approximately 21 days exposure to study drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All subjects, study personnel (including the Investigator, study coordinator(s), pharmacist/designee), and the Sponsor will be blinded to the identity of the study drug (active or placebo) administered to subjects.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject can provide written informed consent.
- •Chronic non-cancer pain diagnosis such as low back pain, chronic neck pain, osteoarthritis, and prolonged post-surgical pain with daily pain for a minimum of 6 months.
- •Self-reported use of prescribed oral opioid medication(s) (tablets, pills or capsules) of at least 50 morphine mg equivalent (MME) but no higher than 240 mg MME daily or near daily (≥5 days per week) for at least 12 weeks and seeking to discontinue their opioid medication.
- •Willing to be treated with non-opioid treatments for pain (in addition to opioid being tapered) for duration of study.
- •Willing to abstain from alcohol use during the study.
- •Willing to partner with his or her pain physician on a subject-centered pain management plan during the study.
- •In generally good health, in the opinion of the Investigator, other than the underlying chronic pain syndrome
- •Women of childbearing potential must have a negative pregnancy test at Screening.
- •Non-pregnant, non-lactating women who are postmenopausal, naturally or surgically sterile, or who agree to use acceptable contraceptive methods throughout the course of the study.
- •Other criteria will be discussed in detail with potential subjects by Site Investigator
排除标准
- •Has a primary diagnosis of complex regional pain syndrome, central neuropathic pain, somatoform pain syndromes, acute nerve root compression, any acute or progressive infectious, inflammatory, or neurological process.
- •Taking methadone, buprenorphine, fentanyl rapid acting products, tapentadol, tramadol, butorphanol, meperidine, or levorphanol for any reason
- •Liver disease that requires medication or medical treatment, and/or AST or ALT levels greater than 3 x ULN.
- •Gastrointestinal or renal disease, which would significantly impair absorption, metabolism or excretion of study drug, or would require medication or medical treatment.
- •Has a diagnosis of epilepsy or history of seizures.
- •Cardiovascular abnormalities at Screening and before randomization (stable hypertension permitted)
- •Self-reported or evidence of opioid use disorder (OUD) or other substance use disorder within last 12 months
- •Any severe or unstable psychiatric disorder including post-traumatic stress disorder, schizophrenia, bipolar disorder, major depression, substance abuse, or suicidality as determined by the Investigator.
- •Subject answers "yes" to "suicidal ideation" in prior 24 months to any items 1 through 5 on the C-SSRS, or subject answers "yes" to any lifetime "suicidal behavior" item on the C-SSRS.
- •Any anticipated or scheduled surgery during the study period or within 30 days before Screening.
- •Other criteria will be discussed in detail with potential subjects by site Investigator
研究组 & 干预措施
Lofexidine
干预措施: Lofexidine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment Emergent AEs and SAEs
时间窗: Day 1 through Day 28
Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation
时间窗: Day 1 through Day 28
Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests
时间窗: Day 1 through Day 28
Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale
时间窗: Day 1 through Day 28
The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a "yes" in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds "yes" to any of the suicidal ideation questions 1 to 3, the Investigator should apply clinical judgment to determine the need for reporting as an AE or SAE and the need for any referral.
Change in Blood Pressure
时间窗: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes.
Change in Pulse
时间窗: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
次要结局
- Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation(Day 1 through Day 28)
- Change in Clinical Opiate Withdrawal Scale (COWS)(Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28)
- Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)(Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28)
- Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)(Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28)
- Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score(Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS))
- Change in Daily Opioid Dose as a Percentage of the Baseline MED(Baseline through Day 28)
- Modified Clinical Global Impression - Subject Version (MCGI-S)(Each scheduled evaluation (Day 1 through Day 28))
- Time to Study Drug Discontinuation(Day 1 through Day 28)
- Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day(Day 1 through Day 28)
- Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale(Change from Baseline to EOS)
- Change in Short Form Health Survey (SF-36) Scale(Change from baseline to End of Study, up to 55 days)
- Change in Insomnia Severity Index (ISI)(Change from baseline to Days 15 and End of Study, up to 55 days)
- Change in Hospital Anxiety and Depression Scale (HADS)(Change from End of Study to Baseline, up to 55 days)
- Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS)(Baseline through Follow-up (assessed daily))
- Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS)(Day 1 through Day 28 (assessed daily))
- Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS)(Baseline through Day 51 (assessed daily))
- Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS)(Day 1 through Day 28 (assessed daily))
- Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED)(Baseline through Day 28)