Clinical Trial Studies Over-The-Counter Meds As Treatment For Alcoholism
UT Southwestern Medical Center and the University of Miami are conducting a clinical trial of over-the counter meds – in this case, for people with bipolar disorder who have a drinking problem.
Dr. Sherwood Brown, Professor of Psychiatry at UT Southwestern Medical Center.
What ties bipolar disorder and alcoholism: “Bipolar disorder is associated with the highest rates of alcohol use disorder of any psychiatric disorder. (Why?) It could be something about symptoms of bipolar disorder, the mood instability, impulsivity, something like that. It could be genetic. We don’t fully understand yet. It’s a bit of a mystery. But it’s an observation that was made well over a hundred years ago in clinical populations that people with bipolar disorder have a real tendency to have drinking problems.”
Why study over the counter medication? “As for treatments for alcoholism, the pharmacotherapies available, none of them worked terribly well. There are several that are FDA-approved, but they’re far from a cure. So there was definitely need for an additional treatments in this area.”
Which medications are you studying? “One is citicoline. The other is pregnenolone. With pregnenolone, we did two randomized placebo-controlled trials for bipolar depression and it was better than placebo in both of those, so we thought it had a mood improving effect, and the literature on animals suggests that it might have the ability to decrease alcohol use, but nobody had really looked at it in humans. And with citicoline, it’s been investigated quite a bit in Europe, again mostly for cognitive disorders. We have looked at it in two clinical trials of people with bipolar disorder and cocaine dependence. It was superior to placebo in both.”
If the clinical trial is a success? "We’d probably look at other populations, perhaps more broadly. The ultimate goal would be to end up with a treatment that, at least for bipolar disorder and alcohol use disorder, decreases alcohol use better than the currently available treatments. And with that particular subpopulation of people with bipolar disorder and alcohol use disorder, the treatment trials at this time have been largely negative. The only one that’s been statistically, significantly positive was one with valproic acid, which is a standard treatment for bipolar disorder and it did seem to decrease alcohol use in that population more than placebo."
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