Lofexidine for Adults Undergoing Lumbar Spine Surgery

NCT04126083 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-0002763
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Withdrawal

Keywords

Opioid tapering; Spine surgery

Outcome Measures

Primary Outcomes (1)

• Opioid Tapering

  The number of patients who achieve a 50% reduction in daily opioid dose at day 12.

  12 days

Study Arms (1)

Lofexidine

EXPERIMENTAL

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

Drug: Lofexidine Oral Tablet

Interventions

Lofexidine Oral Tablet DRUG

lofexidine 0.54 mg 4 times daily

Lofexidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years.
• Chronic lumbar spine pain for ≥ 3 months duration.
• Scheduled for elective lumbar spine surgery.
• Daily morphine equivalent dose between 50 mg and 200 mg.

You may not qualify if:

• Cancer-related pain.
• 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.
• 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.
• 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.
• Active substance abuse disorder.
• 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.
• History of adverse effects attributed to opioid tapering or lofexidine use.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• USWM, LLC (dba US WorldMeds): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 30531234 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

lofexidine

Results Point of Contact

• Title: W. Michael Hooten, M.D.
• Organization: Mayo Clinic

Hooten.William@mayo.edu

507-266-9672

Study Officials

• William M Hooten, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open label design
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label design

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: September 1, 2019
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: February 23, 2022
• Results First Posted: February 23, 2022

Record last verified: 2022-01

Locations

US (1)