Lofexidine for Adults Undergoing Lumbar Spine Surgery

Phase 4

Completed

• Conditions: Opioid Withdrawal
• Interventions: Drug: Lofexidine Oral Tablet

• Registration Number: NCT04126083
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2022-01
• Results First Submitted: 2022-01-31
• Results First Submitted QC: 2022-01-31
• Last Update Submitted: 2022-01-31
• Results First Posted: 2022-02-23
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lofexidine	Lofexidine Oral Tablet	Patients will receive lofexidine 0.54 mg 4 times daily and the baseline opioid dose will be reduced by 10% daily.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States