With overdose rates involving cocaine soaring nearly 27% in 2020, researchers at The University of Texas Health Science Center at Houston (UTHealth) hope that a clinical trial combining a medication approved for the treatment of Type 2 diabetes with cognitive behavioral therapy (CBT) can help prevent relapse in cocaine use disorder patients.
“This tragic rise in drug use has been attributed in part to uncertain and stressful times surrounding the COVID-19 pandemic,” said Joy M. Schmitz, PhD, co-principal investigator of the trial with Scott D. Lane, PhD, of the Center for Neurobehavioral Research on Addiction in the Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences at McGovern Medical School at UTHealth.
Funded with a $2.6 million grant from the National Institute on Drug Abuse (R01DA048026), the Phase II, double-blind, randomized clinical trial, which just opened for enrollment, is looking at pioglitazone, which is used to treat Type 2 diabetes.
The mechanism of action for pioglitazone is complex, but the medication includes anti-neuroinflammatory effects, making it a possible treatment for neurological conditions such as Parkinson’s disease, Alzheimer’s disease, brain trauma, and stroke. Similar to these brain diseases and injuries, studies of cocaine addiction conducted at UTHealth and elsewhere have shown that chronic cocaine use can have widespread neurotoxic effects, including in areas of the brain associated with cognitive function.
The researchers have teamed up with The Right Step Center in Houston to offer eligible participants a two-step treatment, which begins with a brief inpatient detoxification at The Right Step to help participants achieve initial abstinence from cocaine.
“For someone who has been using for years, quitting cocaine is no small feat,” Schmitz said. “The second step is all about relapse prevention.”
After the initial detoxification, participants will receive 12 weeks of outpatient treatment consisting of individual CBT combined with either pioglitazone or placebo. The study will enroll 60 participants.
“Our thinking is that pioglitazone will facilitate the recovery process in these individuals by improving neural and cognitive functioning so that patients might benefit more from the behavioral therapy,” said Schmitz, who holds the Louis A. Faillace, MD, Professorship. “The combination of CBT with pioglitazone is expected to lead to longer term abstinence.”
The grant builds on previous research by Lane and Schmitz, who conducted the first human neuroimaging study to demonstrate how pioglitazone treatment can change brain white matter integrity in patients with cocaine use disorder. Their published findings showed that pioglitazone produced significant improvement in white matter integrity compared to placebo. Additionally, patients who received pioglitazone showed reduced craving for cocaine.
“Pioglitazone is a medication that modifies a brain receptor system called PPAR-gamma. It has several promising effects, including reducing inflammation. Through this mechanism, we expect that pioglitazone will help protect the brain from the inflammatory damage created by cocaine use. This protection should in turn facilitate more effective treatment outcomes,” said Lane, professor and vice chair for research in the Faillace Department of Psychiatry and Behavioral Sciences.
Co-investigators from the Department of Diagnostic and Interventional Imaging in McGovern Medical School are Khader Hasan, PhD, professor; and Ponnada Narayana, PhD, professor and holder of the Chair in Biomedical Engineering; from the Faillace Department of Psychiatry and Behavioral Sciences, Robert Suchting, PhD, assistant professor; and from the Department of Pediatrics, Charles Green, PhD, associate professor. Lane and Narayana are faculty members of The University of Texas MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences.
For more information, please call 713-500-DRUG (3784) or visit: cnraclinic.com/2step
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