NCT04126083

Lofexidine for Adults Undergoing Lumbar Spine Surgery

Lofexidine for Rapid Pre-Operative Opioid Tapering in Adults Undergoing Lumbar Spine Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.

Detailed description

In this clinical trial, an open label design will be used to facilitate opioid tapering during a 12-day period prior to elective spine surgery. The primary outcome measure of this study is the number of patients who achieve a 50% reduction in daily opioid dose at day 12.

Conditions

• Opioid Withdrawal

Interventions

Type	Name	Description
DRUG	Lofexidine Oral Tablet	lofexidine 0.54 mg 4 times daily

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-04-15
• Completion: 2021-04-15
• First posted: 2019-10-15
• Last updated: 2022-02-23
• Results posted: 2022-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study