Lofexidine for Adults Undergoing Lumbar Spine Surgery

Opioid Withdrawal Clinical Trial

Official title:

Lofexidine for Rapid Pre-Operative Opioid Tapering in Adults Undergoing Lumbar Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126083
• Other study ID #: 19-0002763
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: April 15, 2021

Study information

• Verified date: January 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Withdrawal

Intervention

Drug:
• Lofexidine Oral Tablet
lofexidine 0.54 mg 4 times daily

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	USWM, LLC (dba US WorldMeds)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fishman M, Tirado C, Alam D, Gullo K, Clinch T, Gorodetzky CW; CLEEN-SLATE Team. Safety and Efficacy of Lofexidine for Medically Managed Opioid Withdrawal: A Randomized Controlled Clinical Trial. J Addict Med. 2019 May/Jun;13(3):169-176. doi: 10.1097/ADM.0000000000000474. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Tapering	The number of patients who achieve a 50% reduction in daily opioid dose at day 12.	12 days

External Links

•   Mayo Clinic Clinical Trials