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Trial record 1 of 1 for:    USWM-LX1-2010
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Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal (TAPER)

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ClinicalTrials.gov Identifier: NCT04070157
Recruitment Status : Recruiting
First Posted : August 27, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

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.

Condition or disease Intervention/treatment Phase
Opioid Withdrawal (Disorder) Drug: Lofexidine Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2020

Arm Intervention/treatment
Experimental: Lofexidine Drug: 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.
Other Names:
  • lofexidine hydrochloride
  • LUCEMYRA

Placebo Comparator: Placebo Drug: 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.




Primary Outcome Measures :
  1. Number of treatment emergent AEs and SAEs by system organ class and preferred term [ Time Frame: Day 1 through Day 28 ]
  2. Number and percent of subjects reporting TEAEs resulting in study drug discontinuation [ Time Frame: Day 1 through Day 28 ]
  3. Percentage of subjects with treatment-emergent elevated liver function tests [ Time Frame: Day 1 through Day 28 ]
  4. Percentage of subjects identified as suicide risk with Columbia Suicide Severity Rating Scale [ Time Frame: Day 1 through Day 28 ]
  5. Change in Blood Pressure [ Time Frame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28 ]
  6. Change in Pulse [ Time Frame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28 ]

Secondary Outcome Measures :
  1. Percentage of subjects who successfully complete each scheduled dose reduction and the opioid taper to complete opioid discontinuation [ Time Frame: Day 1 through Day 28 ]
  2. Change in Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28 ]
  3. Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) [ Time Frame: 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 ]
  4. Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) [ Time Frame: 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 ]
  5. Modified Clinical Global Impression - Rater Version (MCGI-R) [ Time Frame: Each scheduled evaulation (Day 1 through Day 28) ]
  6. Modified Clinical Global Impression - Subject Version (MCGI-S) [ Time Frame: Each scheduled evaulation (Day 1 through Day 28) ]
  7. Time to study drug discontinuation [ Time Frame: Day 1 through Day 28 ]
  8. Number of non-opioid concomitant medications for withdrawal symptoms used by study day [ Time Frame: Day 1 through Day 28 ]
  9. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale [ Time Frame: Baseline to Days 28 and 51 ]
  10. Chnage in Short Form Health Survey (SF-36) scale [ Time Frame: Baseline to Day 28 ]
  11. Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline to Days 15 and 28 ]
  12. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to Day 28 ]
  13. Change in Average Chronic Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline through Day 51 (assessed daily) ]
  14. Change in Average Overall Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Day 1 through Day 28 (assessed daily) ]
  15. Change in Worst Chronic Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline through Day 51 (assessed daily) ]
  16. Change in Worst Overall Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Day 1 through Day 28 (assessed daily) ]
  17. Change in daily opioid dose expressed as morphine equivalent dose (MED) [ Time Frame: Baseline through Day 28 ]
  18. Change in daily opioid dose as a percentage of the baseline MED [ Time Frame: Baseline through Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 alochol 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070157


Contacts
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Contact: Shelley Stanley 502-815-8131 sstanley@usworldmeds.com

Locations
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United States, California
Westview Clinical Research, LLC Recruiting
Placentia, California, United States, 92870
United States, Florida
Gold Coast Research, LLC Recruiting
Plantation, Florida, United States, 33317
United States, Georgia
Georgia Clinical Research, LLC Recruiting
Lawrenceville, Georgia, United States, 30044
United States, Kentucky
Otrimed Corporation (Otrimed Clinical Research Center) Recruiting
Edgewood, Kentucky, United States, 41017
United States, North Carolina
The Center for Clinical Research, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
US WorldMeds LLC
Investigators
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Study Director: John Peppin, DO US WorldMeds Medical Monitor

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Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT04070157     History of Changes
Other Study ID Numbers: USWM-LX1-2010
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by US WorldMeds LLC:
Opioid Withdrawal Syndrome
OWS
Opioid taper
Opioid withdrawal
Opioid reduction
Stopping opioids
Opioid discontinuation
non-opioid pain management
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lofexidine
Clonidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Narcotic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympatholytics
Autonomic Agents