Lofexidine for Adults Undergoing Lumbar Spine Surgery
Condition: Opioid Withdrawal
Intervention: Lofexidine Oral Tablet
Intervention description: lofexidine 0.54 mg 4 times daily
Intervention MeSH terms: Lofexidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label design
Masking: None (Open Label)
Masking description: Open label design
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Opioid tapering; Spine surgery

Summary:

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

Eligibility criteria:

        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.