NIDA Launches First Large-Scale National Study
to Treat Addiction to Prescription Pain Medications
Researchers funded by the National Institute on Drug Abuse (NIDA),
part of the National Institutes of Health, are launching 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 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 abuse of prescription opiates continues to be unacceptably
high, producing steep increases in emergency room admissions,’’ said
NIH Director Dr. Elias A. Zerhouni. “This trial is part of our
ongoing commitment to develop better treatment approaches for drug
abuse and addiction, so devastating to millions of Americans and
their families.”
The study 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.
The study, which seeks to enroll 648 participants, will be carried
out at 11 sites across the country. Participants will include people
who take prescription drugs for chronic pain and have become addicted
to them, as well as those who abuse painkillers for nonmedical
reasons, including to get high. Several of the study sites are
located in rural areas experiencing high rates of abuse of prescription
pain medications, particularly OxyContin.
“This study is important because most of the research to date
has been done on treatment for those addicted to heroin not prescription
pain medications,” said Roger Weiss, MD, clinical director of McLean’s
Alcohol and Drug Abuse Treatment Center and lead investigator for
the study. “It also isn’t clear whether people who started taking
these medications for legitimate reasons will respond to the same
treatment in the same way as those who use pain medications solely
on an illicit basis.”
“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.”
Subjects enrolled in this study 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 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.
For more information about the study, go to: http://www.drugabuse.gov/CTN/protocol/0030.html.
The National Institute on Drug Abuse is a component of the National
Institutes of Health, U.S. Department of Health and Human Services.
NIDA supports most of the world’s research on the health aspects
of drug abuse and addiction. The Institute carries out a large
variety of programs to ensure the rapid dissemination of research
information and its implementation in policy and practice. Fact
sheets on the health effects of drugs of abuse and information
on NIDA research and other activities can be found on the NIDA
home page at www.drugabuse.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.
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