Clinical Trials

Study Title

HS-16-555

Purpose

Chronic Low Back Pain

Evaluate the safety and effectiveness of an investigational drug called CAM2038 in treating chronic low back pain.

Eligibility

Subjects who have chronic low back pain and are currently being treated with opioid medications.

Study Process

This clinical research study is testing the safety and effectiveness of an investigational drug called CAM2038 in treating chronic low back pain, which will be given in weekly injections and then monthly injections. CAM2038 by injection releases buprenorphine into the body continuously over 1 week or 1 month. Buprenorphine is an opioid medication that is used to treat moderate to severe acute and chronic pain, and opioid use disorders. Patients age 18-75 with moderate to severe low back pain and taking opioids for the treatment of back pain will be enrolled into the study with five phases. The first phase is Screening, followed by Transition Phase, Titration (Open-label) Phase, Double-Blind Phase, Final and Follow-up Phase.