You are being asked to take part in this clinical research study because you have chronic low back pain that is currently being treated with opioid medications. This clinical research study is testing the safety and effectiveness of an investigational drug called CAM2038 in treating your 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.
An investigational drug is a drug that has not been approved by the United States (US) Food and Drug Administration (FDA).
After you are in the study for at least 2 days or up to 2 weeks (the screening phase), you will be asked to reduce your current opioid medication daily until you are taking equal to or less than the equivalent of 80 mg of morphine. Then, you will switch from your current opioid medication to immediate-release (IR) morphine for at least 2 days, (possibly more than 2 days) depending upon how you feel.
The study doctor will determine when you are ready to have an injection of the study drug test dose (CAM2038).