Clinical Monitoring Challenges In Human Abuse Liability Studies

By Paul Freeman, Deirdre Stonestreet, Jennifer Sozio, and Francine High, INC Research/InVentiv Health

Clinical trials conducted to assess the potential for a drug to be abused stand out as specialized, complex studies in the already specialized and complex field of clinical development. And they are becoming more necessary and commonplace with the volume of compounds targeting the central nervous system.The global use of opioids (as measured in morphine equivalence) has grown exponentially over the past two decades, as reported by the International Narcotics ControlBoard (INCB). Interestingly, the greatest use is in the U.S., which represents 5.5 percent of the world population and accounts for 55.9 percent of morphine consumption.

According to a U.S. Drug Enforcement Administration (DEA) report, "Prescription drug abuse continues to be the nation's fastest growing drug problem,” with more than 4.5 million Americans abusing pain relievers. The National Institute on Drug Abuse reported that approximately 26 million Americans (8 percent of the population) said that they'd used a prescription drug for nonmedical reasons in the prior year. The drugs most commonly abused are opioids and central nervous system depressants (sedatives and tranquilizers) and stimulants (prescribed for attention-deficit hyperactivity disorder, narcolepsy or obesity).