The nation’s growing problem regarding prescription painkiller abuse and the support of the National Institute on Drug Abuse for an exploratory clinical study of a new potential therapy for opium addiction and withdrawal were the topics of a public presentation made by Frank Vocci, NIDA’s Director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse, in New York City.

Opioid medications, particularly prescription painkillers, are widely used to treat both acute and chronic pain. Unfortunately, as a NIDA study has shown, illicit opioid abuse has alarmingly increased over the past years. NIDA also found in a 2004 study that the painkillers Vicondin and OxyContin are the most widely abused prescription drugs, especially by adolescents.

Dr. Vocci notes that the opioid addiction problem in the county is an unmet medical situation. Furthermore, he warns that the continued non-medical use and abuse of prescription medicines is a growing and serious problem that plagues the public health scene. “In fact, an estimated 33 million people have used prescription drugs for non-medical reasons in their lifetimes – approximately 15 percent of the U.S. adult population,” he added.

Opioid treatment is traditionally done through detoxification but withdrawal symptoms often get in the way to prevent patients to discontinue their treatment. There are still no drugs approved for treatment of withdrawal symptoms and several of the current treatment methods produce undesirable side effects.

This absence of approved drugs and suitable treatment programs is NIDA’s basis to support an exploratory and clinical trial to be conducted by Columbia University/New York State Psychiatric that will test the safety and tolerability of AV411, a non-opioid compound currently being developed by biopharmaceutical company Avignen.

AV411 is hoped to reduce the symptoms of withdrawal and to decrease addiction as well as improve the pain relief capacity of most opioid-based medicine. Previous pre-clinical studies have already revealed that this medication can weaken opioid induced rewards and withdrawal symptoms. Moreover, the drug was shown to have a potential in preventing methamphetamine addiction relapse.

In the current study, AV411 will be given to heroin addicts maintained on morphine twice a day over a 14-day trial period, after which the potential of the drug in withdrawal symptoms along with its impact on opioid-induced analgesia would be assessed and determined.