By Cameron Cucuzzella
With the nation in the middle of an ongoing opioid crisis, there is a critical need for the development of nonopioid treatments for safe and effective treatment of pain symptoms. In response, researchers in the Department of Psychiatry & Behavioral Sciences at Duke University School of Medicine and the Durham VA Health Care System/Mid-Atlantic Mental Illness Research Education Clinical Center of Excellence investigated the use of a nonopioid treatment for chronic low back pain in US military veterans.
Associate professor Jennifer Naylor, PhD, and professor Chris Marx, MD, conducted a randomized, double-blind, placebo-controlled trial showing that pregnenolone, a neurosteroid, may be a safe and effective treatment for alleviating chronic back pain. The results were recently published in JAMA Open Network.
Neurosteroids are molecules that are made in the brain and other parts of the body that have diverse properties, including analgesic actions. These molecules have potential to be developed as new treatments for conditions such as chronic pain and commonly co-occurring conditions.
Ninety-four Iraq and Afghanistan military veterans with chronic low back pain were enrolled in a six-week randomized, double-blind, placebo-controlled trial with pregnenolone at the Durham VA Health Care System. After a week of receiving placebo medication (sugar pill), veterans were randomized to receive either pregnenolone or placebo for four weeks.
Participants completed a daily pain diary, documenting their pain scores each day. In addition, participants provided information about how much pain was interfering with their ability to function. The investigators compared scores before and after treatment with pregnenolone or placebo to determine if pregnenolone improved pain and pain-related function.
Veterans treated with pregnenolone reported significant reductions in pain intensity and pain interference compared to the placebo group. Roughly 50 percent of those in the pregnenolone group experienced a 20 percent reduction in pain intensity, while only 25 percent of those in the placebo group experienced such a significant decrease. Additionally, veterans treated with pregnenolone reported a notable reduction in pain interference in two domains, specifically improvements in work and activity. These results were both statistically significant and clinically meaningful.
This study was the first to explore the use of pregnenolone in treating a chronic pain condition. Although pregnenolone may be a safe alternative to opioids for alleviating chronic low back pain, there remains much to learn about this treatment. The authors suggest that future studies explore longer duration of treatment and multiple doses, as well as the possible use of this neurosteroid to reduce pain in other chronic conditions.
“Although very preliminary, pregnenolone outperformed placebo in this randomized clinical trial and we are optimistic that future investigations using pregnenolone will improve pain and function for our U.S. military veterans,” says Naylor.
“Neurosteroids appear to be promising therapeutics for the alleviation of chronic pain, in addition to having potential for the treatment of other central nervous system disorders,” Marx adds. “In addition, pregnenolone was very well-tolerated.”
Other Duke Psychiatry & Behavioral Sciences researchers who contributed to this study include Jason Kilts, Lawrence Shampine, Gillian Parke, Ryan Wagner, Steven Szabo, Karen Smith and Susan O’Loughlin.
Dr. Naylor and Dr. Marx discussed their findings in an interview on Jama Network Open Live. Watch the video.
Read the full article in Jama Network Open.