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

US WorldMeds (USWM)

Status and phase

Terminated

Phase 2

Conditions

Opioid Withdrawal (Disorder)

Treatments

Drug: Placebo

Drug: Lofexidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04070157

USWM-LX1-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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