Opioid Withdrawal
Conditions
Keywords
Opioid tapering, Spine surgery
Brief summary
The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.
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.
Interventions
DRUGLofexidine Oral Tablet
lofexidine 0.54 mg 4 times daily
Sponsors
USWM, LLC (dba US WorldMeds)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label design
Intervention model description
Open label design
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Tapering | 12 days | The number of patients who achieve a 50% reduction in daily opioid dose at day 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lofexidine Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily.
Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lofexidine |
|---|---|
| Age, Continuous | 53 years |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Opioid Tapering
The number of patients who achieve a 50% reduction in daily opioid dose at day 12.
Time frame: 12 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lofexidine | Opioid Tapering | 5 Participants |