A Study of Lofexidine for Rapid Opioid Tapering in Adults

Overview

About this study

The purpose of this study is to assess the effects of lofexidine on opioid tapering in adults undergoing opioid tapering prior to elective lumbar spine surgery. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18 to 70 years old.
  • Chronic lumbar spine pain or other non-spine pain for ≥ 3 months duration.
  • Scheduled for elective lumbar spine surgery or other non-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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Hooten, M.D.

Open for enrollment

Contact information:

Mayo Pain Clinic

(507) 284-2511

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available