March 30, 2016 -- It’s been called a magic shot or miracle drug for opioid addiction.
The medication, a once-monthly injection called Vivitrol, appears to cut the risk of relapse in half, at least while people get the shots.
“I think this deserves a lot of attention,” said Francis Collins, MD, PhD, director of the National Institutes of Health, who presented the results of a new study on Vivitrol Tuesday at the National Rx Drug and Heroin Summit in Atlanta. The study pitted the drug against other kinds of medications that treat addiction to opioids.
The new study was conducted in an especially vulnerable group: opioid addicts who had recently been released from prison. But Collins says “it adds another powerful option” for addicts that certainly could be used in other treatment settings, too.
“I would think also that this would be a potentially important moment for rehabilitation facilities to think about this. Not just for people who are being released from jail, but for people who have been in a rehab facility going through a program where they have ultimately ended up abstinent and wanted to stay that way on release, this would seem like a powerful option,” he said.
About 2.6 million people in the U.S. are addicted to opioids, according to the Substance Abuse and Mental Health Services Administration. Since 2001, the number of people who have fatally overdosed on prescription opioids has more than tripled, and the number of people who have died from heroin overdoses has increased more than 600%.
Vivitrol, a long-acting version of the medication naltrexone, isn’t without side effects. And it’s expensive. Although the drug has been FDA approved to treat opioid addiction since 2010, it hasn’t been widely used. Collins said he thought cost was the biggest reason.
“There’s sticker shock when you tell people it costs $1,200 per month, but that’s basically what we’re paying for hepatitis C, HIV, and other behavioral health maintenance medications,” said Joshua Lee, MD, an associate professor of medicine and psychiatry at New York University Langone Medical Center and lead researcher of the study, which was sponsored by the National Institutes of Health.
The Vivitrol shots given in the study were donated by Alkermes, the company that makes the drug. Alkermes also provided grant support to some of the study investigators, including Lee.
Lee said Medicaid covers the cost after doctors get advance permission to prescribe it, called a prior authorization.
About two-thirds of the 2.3 million prisoners in the U.S. are addicted to drugs or alcohol, and one-quarter of all prisoners are addicted to opioids like heroin or oxycodone.
Studies show that about three-quarters of jailed addicts will relapse within 3 months of their release. Even when they were referred to medication-assisted treatments with the drugs methadone or buprenorphine (Suboxone) -- treatments that have been proven to help people stay clean -- one study found only 8% followed through and got help.
At the same time, parolees are much more likely to overdose and die in the weeks after their release than at any other point in their addiction.
The new study, which was published in the New England Journal of Medicine, followed about 300 people, mostly middle-aged men, who had recently been released from prison. Nearly 90% of them were addicted to heroin.
Half the group was randomly chosen to get the usual treatment, which consisted of referrals to relapse prevention services, counseling, and prescriptions for methadone or Suboxone -- pills that can prevent a relapse. The other half got counseling and a monthly injection of Vivitrol.
After 6 months, only 43% of the people in the Vivitrol group had relapsed compared to 64% of the group that got the usual treatment. Vivitrol cut the risk that a person would relapse by almost half for the 6 months people were taking the drug.
What’s more, even a year after stopping the treatment, there were no overdoses in the Vivitrol group, but there were seven in the group that got the usual treatment.
“It’s not for everybody. You need to be in an abstinence situation to start this, otherwise you’ll induce a terrible withdrawal, but for those who have achieved abstinence, this has particular appeal,” Collins said.
The real benefit of the drug is compliance. With methadone, people have to travel to a clinic to get a daily dose until they’re considered stable enough to do it on their own, or they have to remember to take a daily Suboxone pill.
Lee also said he doesn’t consider the drug to be a magic bullet. It didn’t seem to curb cocaine or heavy alcohol use compared to other treatments, and it didn’t seem more likely to help keep the men in his study out of jail compared to usual treatment.
What’s more, while people did better when they were getting the Vivitrol shots, after a year off of treatment, about half the men in the study had relapsed, no matter what they’d initially done to stay sober. So it’s not clear how long people need to get the shots to maintain their sobriety.
People getting Vivitrol also reported more side effects, mainly headaches and upset stomach.