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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

TerminatedPhase 2NCT04070157
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
  • Opioid Withdrawal (Disorder)
Interventions
Sponsor
USWM, LLC (dba US WorldMeds)
Start date
2019-08-02
Primary completion
2019-11-27
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
12

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04070157