- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126083
Lofexidine for Adults Undergoing Lumbar Spine Surgery
January 31, 2022 updated by: W. Michael Hooten, Mayo Clinic
Lofexidine for Rapid Pre-Operative Opioid Tapering in Adults Undergoing Lumbar Spine Surgery
The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.
Study Overview
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lofexidine
Patients will receive lofexidine 0.54 mg 4 times daily and the baseline opioid dose will be reduced by 10% daily.
|
lofexidine 0.54 mg 4 times daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Tapering
Time Frame: 12 days
|
The number of patients who achieve a 50% reduction in daily opioid dose at day 12.
|
12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William M Hooten, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
April 15, 2021
Study Completion (Actual)
April 15, 2021
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
February 23, 2022
Last Update Submitted That Met QC Criteria
January 31, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Narcotic Antagonists
- Lofexidine
Other Study ID Numbers
- 19-0002763
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Individual participant data plan is undetermined.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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