Autopsy report · NCT04070157

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

“COVID pandemic and enrollment issues necessitating an adjustment to the study design.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 4 months before it stopped.
• 4 participants enrolled.
• Results were posted on the registry 4 years 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

USWM, LLC (dba US WorldMeds)

Sponsor type

Industry

Conditions

Opioid Withdrawal (Disorder)

Interventions

Lofexidine; Placebo

Participants

4

Sites

12

Countries

United States

Trials that died the same way

• Better Together: Reablement and Caregivers
  “Due to COVID-related issues had to change study design.” (73% match in meaning)
• Social Engagement Strategies to Improve Medication Adherence
  “Inability to complete enrollment caused by COVID-19 and underpowered to conduct analysis” (70% match in meaning)
• Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab
  “Due to enrollment difficulties compounded by the COVID pandemic.” (70% match in meaning)
• Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases
  “Enrollment was affected due to the COVID-19 pandemic” (70% match in meaning)
• Measures to Improve Outcomes After an Opioid Overdose
  “COVID-19 pandemic interfered with ability to conduct study.” (69% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.