Clinical trial NCT04070157: Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Opioid Withdrawal (Disorder)
Keywords: Opioid Withdrawal Syndrome
OWS
Opioid taper
Opioid withdrawal
Opioid reduction
Stopping opioids
Opioid discontinuation
non-opioid pain management
Lead sponsor: USWM, LLC (dba US WorldMeds)
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Treatment Emergent AEs and SAEs
timeFrame: Day 1 through Day 28
measure: Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation
timeFrame: Day 1 through Day 28
measure: Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests
timeFrame: Day 1 through Day 28
measure: Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale
timeFrame: Day 1 through Day 28
measure: Change in Blood Pressure
timeFrame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
measure: Change in Pulse
timeFrame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Secondary outcomes:
measure: Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation
timeFrame: Day 1 through Day 28
measure: Change in Clinical Opiate Withdrawal Scale (COWS)
timeFrame: Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28
measure: Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)
timeFrame: 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
measure: Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)
timeFrame: 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
measure: Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score
timeFrame: Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS)
measure: Modified Clinical Global Impression - Subject Version (MCGI-S)
timeFrame: Each scheduled evaluation (Day 1 through Day 28)
measure: Time to Study Drug Discontinuation
timeFrame: Day 1 through Day 28
measure: Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day
timeFrame: Day 1 through Day 28
measure: Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale
timeFrame: Change from Baseline to EOS
measure: Change in Short Form Health Survey (SF-36) Scale
timeFrame: Change from baseline to End of Study, up to 55 days
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Change from baseline to Days 15 and End of Study, up to 55 days
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from End of Study to Baseline, up to 55 days
measure: Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS)
timeFrame: Baseline through Follow-up (assessed daily)
measure: Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS)
timeFrame: Day 1 through Day 28 (assessed daily)
measure: Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS)
timeFrame: Baseline through Day 51 (assessed daily)
measure: Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS)
timeFrame: Day 1 through Day 28 (assessed daily)
measure: Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED)
timeFrame: Baseline through Day 28
measure: Change in Daily Opioid Dose as a Percentage of the Baseline MED
timeFrame: Baseline through Day 28
Other outcomes:
Locations:
city: Placentia
country: United States
facility: Westview Clinical Research, LLC
state: California
city: Rancho Mirage
country: United States
facility: Vitamed Research
state: California
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Lawrenceville
country: United States
facility: Georgia Clinical Research, LLC
state: Georgia
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Evansville
country: United States
facility: Global Scientific Innovations
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Overland Park
country: United States
facility: Neuroscience Research Center, LLC
state: Kansas
city: Edgewood
country: United States
facility: Otrimed Corporation (Otrimed Clinical Research Center)
state: Kentucky
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Raleigh
country: United States
facility: Duke Innovation Pain Therapies Clinic at Brier Creek
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
Study officials:
affiliation: US WorldMeds Contract Medical Monitor
name: John Peppin, DO
role: STUDY_DIRECTOR
References: