Status:
COMPLETED
Lofexidine for Adults Undergoing Lumbar Spine Surgery
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
USWM, LLC (dba US WorldMeds)
Conditions:
Opioid Withdrawal
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04126083
Start Date
September 1 2019
End Date
April 15 2021
Last Update
February 23 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905