Prescription opioids – the most commonly prescribed drugs in the U.S. that are fostering a wave of painkiller addiction – are the focus of theSeton Mind Institute’s first-ever National Institutes of Health-sanctioned clinical trial.
The study is now under way – and researchers are seeking Central Texans who are good candidates to try a new drug that could help them kick this painkiller habit.
Led by Dr. Carlos Tirado, clinical director of chemical dependency services at Seton Shoal Creek Hospital, the study concerns a medication under development called lofexidine hydrochloride, which treats acute withdrawal from short-acting opioids. While lofexidine has been available in Europe for more than a decade, it is not yet in use in the U.S.
“There currently is a national epidemic of prescription opioid abuse,” said Tirado, who also is an assistant professor of psychiatry with the University of Texas Southwestern faculty associated with Seton Healthcare Family. “A recent Centers for Disease Control study showed that more people die in the U.S. from prescription opioid toxicity than in traffic accidents.”
Those addicted to these painkillers are not stereotypical drug addicts. Tirado noted they can be employed, hardworking people who hurt their backs or mothers recovering from a C-section during child birth.
“Prescription painkiller abuse poses a major challenge to our health care system, with 85 percent of opioid addicts using them, not heroin,” he said. “We need to build evidence-based and innovative clinical programs to address the greater demand for treating painkiller dependence.”
Seton Mind Institute is one of just 10 sites nationally selected to participate in this drug trial and, so far, it is No. 2 is signing up participants. Sixteen Central Texans have qualified so far and the goal is to sign up 60 by September 2014.
For the lofexidine trial, applicants must be 18 years of age or older; seeking treatment for opioid dependence and available for a seven-day inpatient hospital stay as part of the study. Those selected to participate will be reimbursed for their time and travel and afterward will receive referrals for substance abuse treatment, intensive outpatient therapy and primary care providers.
During the week-long hospital stay, study participants will get either a 2.4 milligram dose of lofexidine, a 3.2 milligram dose or a placebo. This will be followed by an optional seven-day treatment period where subjects can be in or out of a hospital and receive one of the two lofexidine dosages.
The goal is to determine not only if lofexdine works, but at what dosage level it works best. Any side effects also will be monitored according to dosage levels.
To schedule a screening to see if you can participate in the trial, contact Ashleigh Smith via email at firstname.lastname@example.org or telephone (512) 324-9999, ext. 11414.
Seton Shoal Creek, which has operated for more than 30 years, and the recently formed Seton Mind Institute had never before been part of such a study. However, Tirado participated in eight trials before joining Seton and brought with him some good clinical trial contacts.
“This first trial opens the door to participate in other trials,” he said. “Seton Mind Institute and Seton Shoal Creek are very well positioned to do clinical research on addiction and other psychiatric conditions.
“Doing research puts you at the forefront of clinical innovation,” he said. “It expands our repertoire of treatment and training opportunities for staff.”
The study also spotlights work the institute and hospital are doing to incorporate best practices, educate physicians and expand hospital and intensive outpatient programs, Tirado said.
Seton Mind Institute delivers a full range of leading-edge psychiatric and psychological services to Central Texas patients. Practitioners and medical staff combine world-class medicine, clinical expertise and bio and neurosciences with the most current tools and research to evaluate and treat a broad spectrum of mental and behavioral ailments.
As Central Texas’s largest behavioral sciences program, and one of the largest in the state providing both outpatient and inpatient care, the institute offers children, adolescents, adults, veterans and seniors exemplary care and treatment to restore hope and healing and help them live healthier, fuller lives.