Men and women climbing out of the dark hole of opiate addiction visit a recovery center in Augusta once a month for an injection that prevents them from getting high.
The shot, a medication called naltrexone — known by the brand name Vivitrol — blocks the brain’s opioid receptors, thwarting the euphoric effects of heroin and prescription painkillers. Patients can’t get high even if they try.
“We have some clients that will tell you right off, ‘This is the best thing that’s ever happened to me,’” said Linda Sexton, medication management director for Crisis & Counseling Centers, the sole prescriber of Vivitrol for opiate dependence in Kennebec County.
Because Vivitrol prevents a high and isn’t potentially addictive like methadone or other narcotic treatments used to wean drug abusers off heroin and prescription painkillers, it has no street value or potential for illicit use, substance abuse experts say. The injection lasts for a month, freeing patients from having to make a daily decision to take it, which helps many stick to a treatment plan.
The number of people seeking opiate abuse treatment in Maine has more than doubled over the past decade. Of the 5,300 Maine residents who sought treatment for addiction to heroin, morphine and prescription painkillers last year, only a tiny fraction was prescribed Vivitrol. But the medication is slowly catching on in Maine and nationally as another alternative in the fight against the epidemic of opiate addiction.
Skeptics question how well Vivitrol will work in the long term, cautioning that the shot isn’t for everyone. Drug abusers must completely detox from opiates for at least a week before their first injection, often slowly and carefully reducing their dosage of replacement therapies such as methadone. Otherwise, Vivitrol can trigger abrupt and painful withdrawal symptoms. That requirement alone eliminates many addicts as potential patients, leaving only those most motivated to get clean.
Then there’s the price. Vivitrol injections can cost $800 to $1,000, more than double the expense of a month’s worth of Suboxone, a more common medication for opiate dependence.
Vivitrol users also are at high risk of an overdose if they skip an injection or take opiates in an bid to override the medication, which lowers tolerance, experts say. Such attempts can lead to dangerous health problems or death.
“Is it a miracle treatment for opiate addiction? Absolutely not,” said Dr. Mark Publicker, a leading addiction medicine specialist who practices at the Mercy Recovery Center in Westbrook. “Is it without risk? No it isn’t.”
‘Great drug for alcoholism’
Naltrexone, originally developed to treat heroin addiction, has been around since the 1980s. The drug was manufactured as a pill that patients had to ingest daily, and never really took off. In 2006, the U.S. Food and Drug Administration approved an extended-release version of the medication for alcoholism treatment.
Vivitrol won FDA approval in 2010 to prevent relapse of heroin, morphine and other opioid drug abuse. The agency described the move as “a significant advancement in addiction treatment.”
Vivitrol won the 2010 approval after a six-month study that compared the medication to placebo treatment in detoxed patients. Patients who took Vivitrol were more likely to remain in treatment and stop using illicit drugs, according to the FDA.
While Vivitrol is a “great drug for alcoholism,” more clinical trials are needed to demonstrate its effectiveness for opioid dependence, Publicker said. He describes Vivitrol as a “valuable addition” to the recovery toolbox, along with methadone and buprenorphine.
Medical research unequivocally shows that most individuals addicted to opiates require some form of medication to recover from their addiction, a chronic brain disease, he said. Methadone and buprenorphine both have proven effective while patients are taking them, he said.
Vivitrol, like any other medication for opioid dependence, must be accompanied by a firm commitment to recovery, including substance abuse counseling, outpatient programs and support systems such as Narcotics Anonymous, Publicker said.
“I think one of the mistakes people make is to think, if I give this guy three months’ worth of Vivitrol, I’ve dealt with the problem,” he said. “And you haven’t.”
MaineCare, the state’s Medicaid program that provides health insurance for low-income residents, covers Vivitrol, but reviews the prescriptions before treatment and must grant prior approval. Unlike methadone and Suboxone, which contains buprenorphine, MaineCare sets no limits on the duration of Vivitrol treatment.
Any licensed prescriber can administer Vivitrol, as opposed to Suboxone, which health providers must acquire a special U.S. Drug Enforcement Administration license to prescribe.
In fiscal year 2011, shortly after Vivitrol’s FDA approval for opioid addiction, MaineCare spent about $123,000 on 140 claims for Vivitrol injections, according to the Maine Department of Health and Human Services. Since then, the expenditures have nearly doubled, to $224,000 covering 259 claims in fiscal year 2014, which ended June 30.
While its use is on the upswing, Vivitrol prescriptions still pale in comparison to prescriptions for Suboxone, said Guy Cousins, head of Maine DHHS’ Office of Substance Abuse and Mental Health Services.
“This is a grain of sand on the beach,” he said.
Cousins cautioned that Vivitrol is just one medication to treat opiate addiction, echoing Publicker’s point that patients also must undergo counseling for their disease.
While opiate-dependent people face a common illness, the medication that works best for each varies, he said. Vivitrol might help one person but not another, much like a pair of glasses can clear a nearsighted person’s vision but utterly fail their farsighted counterpart, Cousins said.
“For a particular type of client that needs this level of intervention, it can be effective if done well … Not all medications help people the same way with their medical conditions,” he said.
Vivitrol’s effectiveness depends on patients returning for their shot, injected into the buttocks, each month. Some people in recovery will commit to that, Publicker said, including those who want to finally stop relying on methadone or buprenorphine. Others won’t.
“It may stop craving, by and large, but it doesn’t stop wanting, and wanting is a big deal,” Publicker said. “If you want to get high, you want to get high.”
Sexton, at Crisis & Counseling, said for her clients who have successfully taken Vivitrol, “Once they start and have their first [injection] they realize that the medication really works and that it reduces or stops their cravings altogether. So they come back freely for their second shot.”
In most cases, the medication should be regarded as a long-term treatment of a year or more, Publicker said. Patients who have been addicted for shorter periods of time with less severe disease, meaning no intravenous drug use and good social supports, might respond well to a shorter course of treatment, he said.
“One month, two months, three months for somebody with the chronic disease of opiate addiction is not helpful,” Publicker said. “It doesn’t change anything. It kind of kicks the can down the road, and may put people at risk for greater risk of overdose.”
Vivitrol patients must be educated and warned about the risk of overdose if they try to get high while taking the medication, he said.
“It zeroes out tolerance, so if people return to using what they were, they’re at great risk of dying of an overdose,” Publicker said.
Vivitrol, like most medications, also carries side effects. In a clinical trial, a small percentage of patients became depressed and suicidal. Other possible effects include liver damage, reactions at the injection site, nausea, fatigue, headache, dizziness and vomiting.
Patients on Vivitrol also must delay any scheduled surgeries because the medication blunts the pain-relieving properties of opiates.
Last year, a handful of Maine substance abuse providers came together to learn more about Vivitrol and its potential in Maine. Eric Haram, director of outpatient behavioral health at Mid Coast Hospital in Brunswick, organized the group of half a dozen providers, who hailed from Aroostook to York counties.
The goal: to learn what barriers might prevent them from incorporating Vivitrol into their practices, and more broadly, statewide. Alkermes, the Dublin-based biopharmaceutical company that makes Vivitrol, spent a few thousand dollars to fund the three-day training session, which also was supported by the Maine Association of Substance Abuse Programs, Haram said.
The group also developed a protocol for how best to introduce the medication to patients, particularly those on replacement drugs such as methadone, and explain its risks and benefits.
While the monthlong blocking effect is a major advantage of Vivitrol, for those facing addiction, the motivation to get clean varies from moment to moment, Haram said. Some struggle to commit to 30 days without drugs.
Across the country, courts and corrections systems are increasingly turning to Vivitrol to combat heroin and prescription painkiller abuse.
A prison system in Barnstable, Massachusetts, offers the medication to newly released inmates with a history of opiate abuse to help them make the transition to life on the outside. A judge in Ohio has even ordered some defendants to use the medication.
Maine’s corrections system has no plans to begin using Vivitrol in its facilities, according to Commissioner Dr. Joseph Fitzpatrick.
But Haram, who runs Mid Coast’s Addiction Resource Center in Brunswick and Damariscotta, would like to see Vivitrol considered more widely in Maine as a treatment option.
“The tendency is for people to really want to polarize the discussion, and say Vivitrol’s good, Suboxone’s bad. Or Suboxone’s good, methadone’s bad,” he said. “The bottom line here is you need the whole toolbox.”