Researchers funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, launched the first large-scale national study evaluating a treatment for addiction to prescription opioid analgesics (i.e., painkillers) such as Vicodin and OxyContin.
NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting the multi-site study, known as the Prescription Opiate Addiction Treatment Study (POATS).
The study, which plans to enroll 648 participants, is being carried out at NYU Medical Center in partnership with Bellevue Hospital Center, as well as at 10 other sites across the country. Participants include people who take prescription drugs for chronic pain and have become addicted to them, as well as those who abuse painkillers for non-medical reasons, including getting “high.” Several of the study sites are located in rural areas experiencing high rates of abuse of prescription pain medications, particularly OxyContin. NYU/Bellevue intends to enroll 54 patients.
This project is a response to the growing national problem of prescription drug abuse in this country. According to the 2005 National Survey on Drug Use and Health, the incidence of new nonmedical users of pain relievers is now at 2.2 million Americans aged 12 and older, surpassing the number of new marijuana abusers (2.1 million). In 2005, more than six million Americans reported current (in the past month) nonmedical use of prescription drugs—more than the number abusing cocaine, heroin, hallucinogens, and inhalants, combined.
The study, which is now open for enrollment, will test the effectiveness of buprenorphine/naloxone tablets, marketed as Suboxone®, along with different models of drug counseling in patients addicted to prescription opioids. Buprenorphine works by acting on the brain's own opiate receptors—targets for heroin, morphine, and prescription opioids—relieving drug cravings without prompting the same intense high or dangerous side effects. When combined with naloxone, buprenorphine's abuse potential is further limited, since those who try to inject it to get high experience severe withdrawal symptoms, while no adverse effects occur when it is taken orally, as prescribed. This medication has been approved for prescribing by specially trained physicians in office-based settings, greatly expanding the treatment options available for opiate addiction.
“Opioid analgesics were designed to help people in pain, and we want to be sure that those who require them for legitimate reasons can continue to effectively manage their pain,” said NIDA Director Dr. Nora D. Volkow. “However, we must also recognize the risk of addiction to pain medications and develop treatments for those who become addicted to them. This trial is an important first step in reaching that goal.”
Marc Gourevitch, MD, Professor of Medicine, Director of the Division of General Internal Medicine, and the Principal Investigator for the NYU/Bellevue site comments, “Addiction to prescription pain killers has rapidly become a major problem, for which effective treatment strategies are sorely needed. Providing medical therapy for this condition in primary care settings will bring relief to many who might not have been comfortable seeking help in specialized treatment programs.”
Subjects will be treated with Suboxone® for one month at the outset. They will then be stabilized and the dose tapered off as part of a detoxification process. If they remain abstinent for two months, they will complete the study. If they relapse and begin abusing prescription opiates again, they may be eligible to go back on the medication for three more months, taper off during a fourth month, and be followed for two months.
In addition, to compare the effectiveness of different behavioral therapies in conjunction with the medication, half the subjects will be enrolled in an intensive individualized drug counseling program when they get their prescriptions. The other half will receive a brief drug counseling session from their doctors.