Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal

NCT04070157 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: USWM-LX1-2010
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 12

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.

Conditions

Opioid Withdrawal (Disorder)

Keywords

Opioid Withdrawal Syndrome; OWS; Opioid taper; Opioid withdrawal; Opioid reduction; Stopping opioids; Opioid discontinuation; non-opioid pain management

Outcome Measures

Primary Outcomes (6)

• Number of Treatment Emergent AEs and SAEs

  Day 1 through Day 28

• Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation

  Day 1 through Day 28

• Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests

  Day 1 through Day 28

• Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale

  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.

  Day 1 through Day 28

• Change in Blood Pressure

  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.

  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

  Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28

Secondary Outcomes (18)

• 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)

Study Arms (2)

Lofexidine

EXPERIMENTAL

Drug: Lofexidine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lofexidine DRUG

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.

Also known as: lofexidine hydrochloride, LUCEMYRA

Lofexidine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• USWM, LLC (dba US WorldMeds): lead

Study Sites (12)

Westview Clinical Research, LLC

Placentia, California, 92870, United States

Location

Vitamed Research

Rancho Mirage, California, 92270, United States

Location

Gold Coast Research, LLC

Plantation, Florida, 33317, United States

Location

Georgia Clinical Research, LLC

Lawrenceville, Georgia, 30044, United States

Location

Injury Care Research

Boise, Idaho, 83713, United States

Location

Global Scientific Innovations

Evansville, Indiana, 47714, United States

Location

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, 50265, United States

Location

Neuroscience Research Center, LLC

Overland Park, Kansas, 66210, United States

Location

Otrimed Corporation (Otrimed Clinical Research Center)

Edgewood, Kentucky, 41017, United States

Location

University of Rochester

Rochester, New York, 14624, United States

Location

Duke Innovation Pain Therapies Clinic at Brier Creek

Raleigh, North Carolina, 27617, United States

Location

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Interventions

lofexidine

Results Point of Contact

• Title: Medical Affairs
• Organization: USWM, LLC

medinfo@usworldmeds.com

1-888-900-8796

Study Officials

• John Peppin, DO

  US WorldMeds Contract Medical Monitor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: August 28, 2019
• Study Start: August 2, 2019
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)