A proof of concept study will assess the effectiveness of two over-the-counter (OTC) supplements in possibly treating alcohol abuse in bipolar disorder patients.

Past research on prescription drugs for this indication have demonstrated little efficacy. However, smaller studies of citicoline and pregnenolone have shown promising results. While there is insufficient evidence to support any of these uses, pregnenolone has been used as a supplement for arthritis, depression, and fatigue, while citicoline supplementation has been linked to improving memory.

The 5-year trial includes patients diagnosed with bipolar disorder and alcohol-use disorder; this population is at higher risk for co-morbidities which are often attributed to either their diagnosis and/or alcohol use. The study will investigate how these two supplements may improve brain function and mood control in this patient population. 

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Over 12-weeks, participants will be assigned citicoline, pregnenolone or a placebo to be taken twice daily; they will also be required to provide feedback at a weekly appointment. Patients will be tracked through 2018 and if either of the OTC supplements are successful in treating alcoholism the study will continue through years 4 and 5.

“This proof of concept study hopes to accomplish what we in the medical community have long hoped for, a medication to reduce alcohol abuse,” said Dr. Ihsan Salloum, co-lead researcher. “In addition, because of their properties, the two drugs being studied could also improve patients’ moods and emotional balance.”

If citicoline and/or pregnenolone are deemed effective at the end of the 5 year trial, larger studies will be initiated to assess their effectiveness in people with alcohol-use disorders who do not suffer from mental health problems.

For more information visit Med.miami.edu.