The University of Maryland School of Pharmacy has received a prestigious $3.7 million grant to develop a drug to treat cocaine addiction based on a molecule originally discovered in the extract of Chinese herbs.
The National Institutes of Health's (NIH) National Institute on Drug Abuse (NIDA) awarded the five-year research grant to Jia Bei Wang, PhD, a professor of pharmaceutical sciences at the School of Pharmacy.
Wang and her collaborators from the University's schools of pharmacy and medicine will develop a drug from a compound called l-tetrahydropalmatine (l-THP), which is the active ingredient in some Chinese medicines. Under the grant, the team also plans to conduct human trials to test the effectiveness of the new drug.
If proven effective, it will be the first drug developed and approved in the United States, and possibly anywhere in the world, to treat cocaine addiction. The grant is the largest ever received from NIH by the University of Maryland School of Pharmacy.
NIDA reported in a 2007 study that there were 2.1 million cocaine users in the United States, and today it estimates about one in six Americans have tried cocaine by the age of 30. Two previous studies sponsored by the NIH found l-THP weakens the cocaine "reward" of brain stimulation in rats. Wang's team will build on those findings and plans to design the first human trials on 1-THP.
Also, a 2008 human trial in China reported that l-THP could reduce cravings and help addicts following detoxification."NIDA's Avant-Garde award series is designed to stimulate high-impact research that may lead to groundbreaking strategies for solving long-standing research challenges. "One of those elusive solutions has been a medication for cocaine addiction, which is addressed by Dr. Wang's proposal," said NIDA Director Nora D. Volkow, MD.
"Our project fits this award mechanism very well because we are addressing an unmet need for treating cocaine addiction," says Wang. "The compound alters the activity of dopamine and other neurotransmitters that are instrumental in the human body's response to addictive drugs."
"Cocaine addiction is a major health concern in both urban and suburban communities and l-THP may be the first effective medication for the treatment of cocaine abuse and addiction approved in this country," says Natalie D. Eddington, PhD, FAAPS, dean of the University of Maryland School of Pharmacy. "Dr. Wang's clinical research is critical and timely, and if successful, it will augment and strengthen the cognitive-behavioral approaches used currently to treat cocaine addiction.
"The School of Pharmacy has a long track record of education and research as it relates to drug addiction. Through our Student Committee on Drug Abuse Education program and our numerous NIH/NIDA funded investigators, we have long emphasized initiatives focusing on minimizing the impact of drug addiction on the citizens of Baltimore and beyond. The interdisciplinary research team and environment supporting Dr. Wang's groundbreaking clinical studies is well-equipped to rigorously evaluate the effectiveness of this novel medication for cocaine abuse."
The team will produce its own formulation of the drug using a Good Manufacturing Practices facility at the School of Pharmacy, directed by Stephen Hoag, PhD, an associate professor of pharmaceutical sciences and a member of the research team, in order to assure a reliable source of the l-THP for the clinical studies.
Phase 1 clinical studies, which will assess the safety, tolerability, pharmacokinetics, and further analyses of 1-THP and its interaction with cocaine in human subjects, could begin in mid-2011.
Wang has extensively studied the Chinese research on 1-THP and six months ago she provided NIDA with samples produced in China. The agency found it to have a unique profile, says Wang. "Chinese medicine is a big treasure box, which I always had in mind as a possible resource to treat drug addiction," she says.
NIDA's Volkow says, "Cocaine abuse and addiction continue to plague our nation." The 2007 National Survey on Drug Abuse and Health estimated there were approximately 610,000 crack cocaine users and adults aged 18 to 25 years had a higher rate of current cocaine use than any other age group.
Founded in 1841, the University of Maryland School of Pharmacy is the fourth oldest school of pharmacy in the U.S. Ranking ninth, the School leads pharmacy education, scientific discovery, patient care, and community engagement in the state of Maryland and beyond. The School's PharmD program expanded to the Universities at Shady Grove in Montgomery County in the fall of 2007, and construction was recently completed on a $62 million, seven-story building adjacent to the School's Pharmacy Hall.