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

Opioid Withdrawal (Disorder) Clinical Trial

— TAPER  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04070157
• Other study ID #: USWM-LX1-2010
• Status: Suspended
• Phase: Phase 2
• Start date: August 2, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2022
• Source: USWM, LLC (dba US WorldMeds)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Withdrawal (Disorder)
• Substance Withdrawal Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Injury Care Research	Boise	Idaho
United States	Otrimed Corporation (Otrimed Clinical Research Center)	Edgewood	Kentucky
United States	Global Scientific Innovations	Evansville	Indiana
United States	Georgia Clinical Research, LLC	Lawrenceville	Georgia
United States	Neuroscience Research Center, LLC	Overland Park	Kansas
United States	Westview Clinical Research, LLC	Placentia	California
United States	Gold Coast Research, LLC	Plantation	Florida
United States	Duke Innovation Pain Therapies Clinic at Brier Creek	Raleigh	North Carolina
United States	Vitamed Research	Rancho Mirage	California
United States	University of Rochester	Rochester	New York
United States	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
USWM, LLC (dba US WorldMeds)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent AEs and SAEs by system organ class and preferred term		Day 1 through Day 28
Primary	Number and percent of subjects reporting TEAEs resulting in study drug discontinuation		Day 1 through Day 28
Primary	Percentage of subjects with treatment-emergent elevated liver function tests		Day 1 through Day 28
Primary	Percentage of subjects identified as suicide risk with Columbia Suicide Severity Rating Scale		Day 1 through Day 28
Primary	Change in Blood Pressure		Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Primary	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	Percentage of subjects who successfully complete each scheduled dose reduction and the opioid taper to complete opioid discontinuation		Day 1 through Day 28
Secondary	Change in Clinical Opiate Withdrawal Scale (COWS)		Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28
Secondary	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
Secondary	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
Secondary	Modified Clinical Global Impression - Rater Version (MCGI-R)		Each scheduled evaluation (Day 1 through Day 28)
Secondary	Modified Clinical Global Impression - Subject Version (MCGI-S)		Each scheduled evaluation (Day 1 through Day 28)
Secondary	Time to study drug discontinuation		Day 1 through Day 28
Secondary	Number of non-opioid concomitant medications for withdrawal symptoms used by study day		Day 1 through Day 28
Secondary	Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale		Baseline to Days 28 and 51
Secondary	Change in Short Form Health Survey (SF-36) scale		Baseline to Day 28
Secondary	Change in Insomnia Severity Index (ISI)		Baseline to Days 15 and 28
Secondary	Change in Hospital Anxiety and Depression Scale (HADS)		Baseline to Day 28
Secondary	Change in Average Chronic Pain as measured by the Numeric Rating Scale (NRS)		Baseline through Day 51 (assessed daily)
Secondary	Change in Average Overall Pain as measured by the Numeric Rating Scale (NRS)		Day 1 through Day 28 (assessed daily)
Secondary	Change in Worst Chronic Pain as measured by the Numeric Rating Scale (NRS)		Baseline through Day 51 (assessed daily)
Secondary	Change in Worst Overall Pain as measured by the Numeric Rating Scale (NRS)		Day 1 through Day 28 (assessed daily)
Secondary	Change in daily opioid dose expressed as morphine equivalent dose (MED)		Baseline through Day 28
Secondary	Change in daily opioid dose as a percentage of the baseline MED		Baseline through Day 28