Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
NCT ID: NCT04070157
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2019-08-02
2019-11-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lofexidine
Lofexidine
Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Placebo
Placebo
Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Interventions
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Lofexidine
Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Placebo
Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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USWM, LLC (dba US WorldMeds)
INDUSTRY
Responsible Party
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Principal Investigators
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John Peppin, DO
Role: STUDY_DIRECTOR
US WorldMeds Contract Medical Monitor
Locations
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Westview Clinical Research, LLC
Placentia, California, United States
Vitamed Research
Rancho Mirage, California, United States
Gold Coast Research, LLC
Plantation, Florida, United States
Georgia Clinical Research, LLC
Lawrenceville, Georgia, United States
Injury Care Research
Boise, Idaho, United States
Global Scientific Innovations
Evansville, Indiana, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
Otrimed Corporation (Otrimed Clinical Research Center)
Edgewood, Kentucky, United States
University of Rochester
Rochester, New York, United States
Duke Innovation Pain Therapies Clinic at Brier Creek
Raleigh, North Carolina, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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USWM-LX1-2010
Identifier Type: -
Identifier Source: org_study_id
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