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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04070157
Recruitment Status : Suspended (Enrollment on Hold (COVID-19))
First Posted : August 28, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE August 2, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • Number of treatment emergent AEs and SAEs by system organ class and preferred term [ Time Frame: Day 1 through Day 28 ]
  • Number and percent of subjects reporting TEAEs resulting in study drug discontinuation [ Time Frame: Day 1 through Day 28 ]
  • Percentage of subjects with treatment-emergent elevated liver function tests [ Time Frame: Day 1 through Day 28 ]
  • Percentage of subjects identified as suicide risk with Columbia Suicide Severity Rating Scale [ Time Frame: Day 1 through Day 28 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • 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 ]
  • Change in Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28 ]
  • 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 ]
  • 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 ]
  • Modified Clinical Global Impression - Rater Version (MCGI-R) [ Time Frame: Each scheduled evaluation (Day 1 through Day 28) ]
  • Modified Clinical Global Impression - Subject Version (MCGI-S) [ Time Frame: Each scheduled evaluation (Day 1 through Day 28) ]
  • Time to study drug discontinuation [ Time Frame: Day 1 through Day 28 ]
  • Number of non-opioid concomitant medications for withdrawal symptoms used by study day [ Time Frame: Day 1 through Day 28 ]
  • Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale [ Time Frame: Baseline to Days 28 and 51 ]
  • Change in Short Form Health Survey (SF-36) scale [ Time Frame: Baseline to Day 28 ]
  • Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline to Days 15 and 28 ]
  • Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to Day 28 ]
  • Change in Average Chronic Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline through Day 51 (assessed daily) ]
  • Change in Average Overall Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Day 1 through Day 28 (assessed daily) ]
  • Change in Worst Chronic Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline through Day 51 (assessed daily) ]
  • Change in Worst Overall Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Day 1 through Day 28 (assessed daily) ]
  • Change in daily opioid dose expressed as morphine equivalent dose (MED) [ Time Frame: Baseline through Day 28 ]
  • Change in daily opioid dose as a percentage of the baseline MED [ Time Frame: Baseline through Day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • 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 ]
  • Change in Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28 ]
  • 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 ]
  • 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 ]
  • Modified Clinical Global Impression - Rater Version (MCGI-R) [ Time Frame: Each scheduled evaulation (Day 1 through Day 28) ]
  • Modified Clinical Global Impression - Subject Version (MCGI-S) [ Time Frame: Each scheduled evaulation (Day 1 through Day 28) ]
  • Time to study drug discontinuation [ Time Frame: Day 1 through Day 28 ]
  • Number of non-opioid concomitant medications for withdrawal symptoms used by study day [ Time Frame: Day 1 through Day 28 ]
  • Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale [ Time Frame: Baseline to Days 28 and 51 ]
  • Chnage in Short Form Health Survey (SF-36) scale [ Time Frame: Baseline to Day 28 ]
  • Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline to Days 15 and 28 ]
  • Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to Day 28 ]
  • Change in Average Chronic Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline through Day 51 (assessed daily) ]
  • Change in Average Overall Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Day 1 through Day 28 (assessed daily) ]
  • Change in Worst Chronic Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline through Day 51 (assessed daily) ]
  • Change in Worst Overall Pain as measured by the Numeric Rating Scale (NRS) [ Time Frame: Day 1 through Day 28 (assessed daily) ]
  • Change in daily opioid dose expressed as morphine equivalent dose (MED) [ Time Frame: Baseline through Day 28 ]
  • Change in daily opioid dose as a percentage of the baseline MED [ Time Frame: Baseline through Day 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Opioid Withdrawal (Disorder)
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Lofexidine
    Intervention: Drug: Lofexidine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: August 23, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04070157
Other Study ID Numbers  ICMJE USWM-LX1-2010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party US WorldMeds LLC
Study Sponsor  ICMJE US WorldMeds LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Peppin, DO US WorldMeds Contract Medical Monitor
PRS Account US WorldMeds LLC
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP