The Seton Mind Institute in Austin is soliciting adults addicted to painkillers for a study of a drug designed to aid in addiction recovery.
The clinical trial, led locally by psychiatrist Carlos Tirado at Seton Shoal Creek Hospital, is sponsored by US WorldMeds LLC in collaboration with the National Institute on Drug Abuse. Austin is among 11 U.S. locations currently recruiting for the study.
A new generation of drugs is being developed to treat drug addiction, including the one in the study, lofexidine hydrochloride. It is an approved therapy in the United Kingdom but has not been approved by the U.S. Food and Drug Administration.
The drug helps to “suppress the uncomfortable physical manifestations of withdrawal — sweating, nausea, vomiting, diarrhea, chills and flu-like feelings,” Tirado said. It is believed to have fewer side effects than clonidine, a drug sometimes used for opioid and alcohol addiction withdrawal, he added.
Possible side effects of lofexidine include drowsiness; dry mouth, throat, and nose; low blood pressure; and slowing of the heart rate.
The trial is its final phase, aimed at proving safety and effectiveness, although it could take several years to gain FDA approval, Tirado said.
Addiction to opioids “is one of the biggest health epidemics right now,” he said.
More people ages 25 to 64 died from drug overdoses than from motor vehicle crashes in 2010, according to the U.S. Centers for Disease Control and Prevention. Sixty percent of the 38,329 overdose deaths were caused by pharmaceuticals.
In Travis County, the medical examiner’s office recorded 71 accidental deaths caused by prescription drugs in 2011, and 48 in 2010.
People who hurt their backs or suffer surgical pain, such as a new mom who had a cesarean section, are among those who “innocently become addicts,” Seton Healthcare Family spokesman Steven Taylor said.
Seton has enrolled 16 people in the trial but hopes to have 60 by September. Participants must be at least 18, be seeking treatment for opioid dependence and be able to spend two weeks receiving treatment, including at least one as an inpatient at Seton Shoal Creek.
Some in the study will get a placebo, or sugar pill, while others get one of two different doses of lofexidine. At the end, those who received a placebo could get lofexidine for free, Tirado said.
Those interested can contact Ashleigh Smith at firstname.lastname@example.org or at (512) 324-9999, ext. 11414.