Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioDelivery Sciences International
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of moderate to severe low back pain for ≥6 months
Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)
Stable health, as determined by Principal Investigator
Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year
Willing and able to comply with all protocol required visits and assessments
You may not be if
Current cancer related pain or received chemotherapy with 6 months of screening
Receiving opioid analgesic medication \>10 mg MSE per day within 28 days of screening
Subjects with a history of other chronic painful conditions
Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
Allergy or contraindications to any opioid or acetaminophen
Surgical procedure for relief of pain with 6 months
Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
History of long QT syndrome or a family member with this condition
Moderate to severe hepatic impairment
Moderate to severe renal impairment
Current or past history of alcohol abuse
Positive urine toxicology screen for drug of abuse
History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
Clareo Health | Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
