Lofexidine for Adults Undergoing Lumbar Spine Surgery

Overview

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

Full Title of Study: “Lofexidine for Rapid Pre-Operative Opioid Tapering in Adults Undergoing Lumbar Spine Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 15, 2021

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.

Interventions

  • Drug: Lofexidine Oral Tablet
    • lofexidine 0.54 mg 4 times daily

Arms, Groups and Cohorts

  • Experimental: Lofexidine
    • Patients will receive lofexidine 0.54 mg 4 times daily and the baseline opioid dose will be reduced by 10% daily.

Clinical Trial Outcome Measures

Primary Measures

  • Opioid Tapering
    • Time Frame: 12 days
    • The number of patients who achieve a 50% reduction in daily opioid dose at day 12.

Participating in This Clinical Trial

Inclusion Criteria

1. Age 18 to 70 years. 2. Chronic lumbar spine pain for ≥ 3 months duration. 3. Scheduled for elective lumbar spine surgery. 4. Daily morphine equivalent dose between 50 mg and 200 mg. Exclusion Criteria:

1. Cancer-related pain. 2. Medical or surgical conditions that could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, cardiac disease, inflammatory bowel disease, renal or hepatic impairment, vascular disease, and history of anaphylaxis. Patients may be excluded for other comorbid medical or surgical conditions based on the physician investigator's discretion. 3. History of schizophrenia or other chronic psychiatric disorder that could be adversely impacted by opioid tapering or use of lofexidine. Patients may be excluded for other comorbid mental health conditions based on the physician investigator's discretion. 4. Neurological condition that impair functioning in an ambulatory setting or could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, Parkinson's disease, amyotrophic lateral sclerosis, or a dementing illness. Patients may be excluded for other neurological conditions based on the physician investigator's discretion. 5. Active substance abuse disorder. 6. Inability to function in an ambulatory care setting due to severe deconditioning requiring use of supportive gait aids including a cane or walker. Patients may be excluded for other functional problems based on the physician investigator's discretion. 7. History of adverse effects attributed to opioid tapering or lofexidine use. 8. Use of medications from drug classes known to have adverse interactions with lofexidine including, but not exclusively limited to, beta-blockers, calcium channel blockers, alpha 1 and 2 receptor antagonists, tricyclic antidepressants, benzodiazepines, and selective serotonin reuptake inhibitors. Patients may be excluded for use of other medications based on the physician investigator's and research pharmacy's discretion.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • USWM, LLC (dba US WorldMeds)
  • Provider of Information About this Clinical Study
    • Principal Investigator: W. Michael Hooten, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • William M Hooten, MD, Principal Investigator, Mayo Clinic

References

Fishman M, Tirado C, Alam D, Gullo K, Clinch T, Gorodetzky CW; CLEEN-SLATE Team. Safety and Efficacy of Lofexidine for Medically Managed Opioid Withdrawal: A Randomized Controlled Clinical Trial. J Addict Med. 2019 May/Jun;13(3):169-176. doi: 10.1097/ADM.0000000000000474.

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