Lofexidine for Adults Undergoing Lumbar Spine Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-04-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Opioid Withdrawal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label design

Study Groups

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Lofexidine

Patients will receive lofexidine 0.54 mg 4 times daily and the baseline opioid dose will be reduced by 10% daily.

Group Type EXPERIMENTAL

Lofexidine Oral Tablet

Intervention Type DRUG

lofexidine 0.54 mg 4 times daily

Interventions

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Lofexidine Oral Tablet

lofexidine 0.54 mg 4 times daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No