Summary
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Subjects with a Recent History of Moderate to Severe Chronic Low Back Pain Currently Treated with Opioids
Total # of Subjects Needed:
Approximately 570 patients will be enrolled at approximately 85 sites in the United States.
Study Details
This study is for individuals who 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.
After participants 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 (Buprenex).
Depending on how you feel after the test dose of Buprenex, you will either:
• receive CAM2038 weekly injections (for up to the next 10 weeks), which releases buprenorphine into the body continuously over 1 week.
• be removed from the study
After up to 10 weekly injections, depending on how you feel, you will be placed into one of the following 4 groups:
1. you will continue to receive weekly injections of the study drug CAM2038.
2. you will begin to receive weekly injections of placebo (placebo looks like the investigational drug but has no active ingredients).
3. you will begin to receive monthly injections of the study drug CAM2038.
4. you will begin to receive monthly injections of placebo (placebo looks like the investigational drug but has no active ingredients).
All injections will be injected just under your skin into either side of your buttock, rotating between your left and right buttock.
Educational Videos
Chronic Low Back Pain Video (1): HERE
Chronic Low Back Pain Video (2): HERE
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study, fill out the online application HERE.