Oct. 12, 2010 -- In 2010, addicts' drugs-of-choice are often found in a bottle with a child-safety lid and a local drug store label. That's the take-home message repeated in reports from local and national public health officials and drug enforcement agents.
Since there are medicine cabinets in SoHo lofts, west Texas cabins, Tampa condos, as well as trailers in Appalachia, the epidemic of opioid-based prescription painkiller abuse knows no boundaries.
But while the disease is ubiquitous, the options are limited: go cold turkey or travel daily to a clinic for methadone -- which is why addiction researchers continue to search for innovative ways to treat not just heroin addicts but also patients addicted to OxyContin, Vicodin, and Percocet, to name a few.
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An emerging strategy is treatment with buprenorphine, also known by the brand names Subutex and Suboxone, for treating patients addicted to any type of opioid.
It's a fairly new approach to fighting the disease -- not just because it has a novel mechanism of action, but because it can be prescribed by a primary care doctor.
The concept of filling a prescription for opioid treatment rather than sending patients off to a specialty clinic is a compelling notion to those faced with the big numbers of addiction.
Since its approval in 2002, buprenorphine has increased access to addiction treatment -- but only incrementally, as addiction experts say barriers to wider deployment still exist. Among those barriers are insurance companies that refuse coverage, as well as an undercurrent of apprehension about the rigors of treating addicts in the primary care community.
"We have a raging epidemic of addiction, and the most effective treatment is buprenorphine," said Dr. Andrew Kolodny, a psychiatrist who specializes in addiction medicine at Maimonides Medical Center in Brooklyn, N.Y. "How long will [patients] have to suffer before they have better access to this treatment?"
Researchers have been working on some solutions, including telemedicine and a website that matches patients with primary care doctors who are willing to treat opioid addiction -- but lessons from the past suggest that change will not come quickly.
Treatment Options for Opioid Addiction
Since the mid-20th century, methadone has been the workhorse of opioid addiction treatment. It's a full agonist, which means it gives users a slight rush -- albeit one that is not as potent as heroin or other opioids.
A patient typically goes to a clinic once a day for a dose and can stay on daily methadone for years. Though clinics are fairly common in urban areas, they can be hard to reach for those in rural areas. And researchers say the rigors and social stigma of seeking treatment at a methadone clinic can be a barrier to care regardless of locale.
On the other end of the treatment spectrum is the much less commonly used naltrexone (ReVia), an opioid antagonist approved in the 1980s for opioid addiction. But this drug is used more commonly to treat alcoholism -- an indication granted in 1995.
It acts as a shield, completely blocking the brain's opioid receptors so that users can't get high no matter what they try.
"A full opioid agonist is a key in the ignition," said Dr. Petros Levounis, director of The Addiction Institute at Roosevelt and St. Luke's Hospitals in New York. "You put it in, the car goes 100 miles per hour."
"A full antagonist like naltrexone is a false key that jams the ignition and the car doesn't go anywhere," he added. "Buprenorphine is the key that starts the car, but it only goes to 40 miles per hour."
It's the only partial agonist for opioid addiction, but is comparable to varenicline (Chantix), a partial agonist for smoking cessation.
Another appealing aspect of buprenorphine, addiction experts say, is the freedom and anonymity it affords. It treats addiction more like a chronic condition such as heart disease or diabetes, rather than a stigmatizing mental condition.
Buprenorphine: The French Connection
The efficacy of the drug has been tested in clinical trials, but addiction medicine specialists more often point to a real life example -- France. The drug was approved there in 1996, after which French authorities reported a five-fold reduction in overdose deaths and a six-fold drop in the number of active injection drug users.
Uptake in the United States has not been quite as rapid. According to Nicholas Reuter, senior public health analyst at the Substance Abuse and Mental Health Services Administration (SAMHSA), data from 2009 show that about 19,000 U.S. physicians are certified to prescribe buprenorphine, and about 640,000 patients are currently receiving treatment.
That's a clear rise from 2005, when just 4,500 doctors were certified and little more than 100,000 patients were on treatment -- not surprising since the U.S. Food and Drug Administration initially required strict limits on its use. Licensed physicians could only treat 30 patients a year.
Reuter says that was to ensure the safe distribution of the drug. The Drug Addiction Treatment Act (DATA) 2000 marked the first time addiction patients could be treated in a physician's office. Concerns arose that this would make it easier for substances to be diverted.
Others say the "methadone lobby" had a hand in crafting the regulation. Addiction experts say that buprenorphine is an economic threat to the industry of drug makers and clinics.
Mark W. Parrino, president of the American Association for the Treatment of Opioid Disorders (AATOD), which was involved in discussions in Washington on the regulation, called speculations about the methadone lobby an "urban legend."
"We don't spend a dollar on lobbying," he told MedPage Today.
Indeed, amendments to DATA 2000 have since been made, and physicians can prescribe to 100 patients at any given time, after they spend a year focused on the initial 30.
Parrino agrees that buprenorphine "is a great drug," even though it's had some challenges to wider distribution.
For instance, as part of the regulation, doctors must take an eight-hour course to obtain a license to prescribe the drug -- though, as Kolodny points out, physicians don't need a course to write opioid painkiller prescriptions.
There are also concerns about random Drug Enforcement Agency checks that some physicians feel may intimidate guests in the waiting room.
But the bigger barrier, some say, may be the lack of primary care physician desire to treat addiction patients.
"There are many myths about addicts," Kolodny said. "Physicians think they are liars and cheats, and just bad people in general. They don't realize that it can happen to anyone."
It's also not covered by all insurers, potentially leaving patients with an out-of-pocket bill in the range of about $350 to $400 per month.
Reuter says it is notable that the drug made its way from zero patients eight years ago to more than a half a million today. But that rate of expansion is nowhere near that of drugs for chronic conditions like heart disease or diabetes. For example, a drug like rosuvastatin (Crestor) for lipid-lowering topped the million prescription mark within months of hitting the market.
Nor has buprenorphine kept pace with the rising epidemic of opioid abuse, Kolodny said. SAMHSA estimates that between two and six million patients in the U.S. abuse opioids, and there's at least an equivalent number of heroin addicts.
Expanding Access to Buprenorphine
Northern Arizona is mountainous, rural, and not remotely related to the urban world of Kolodny. Like many rural areas, the prescription painkiller epidemic is rampant, but the region's only methadone clinic is in Flagstaff and there is just one physician certified to prescribe buprenorphine.
The person is Dr. Sue Sisley, and her neighborhood is several hundred square miles of Arizona territory.
But technology allows Sisley to make house calls even when the house is more than 150 miles away from her desk. She treats patients via a telemedicine program at the University of Arizona.
In some ways, telemedicine can be more intimate than the in-person experience, Sisley says.
To illustrate, she tells the story of one of her patients, a concert pianist who had become addicted to opioid painkillers. He was, she said, so disgraced by his addiction, that he refused to even touch the keys on his piano. She prescribed buprenorphine.
Then, during a video follow-up after starting on the drug, he angled the camera toward the instrument and started playing.
"It was amazing," Sisley said. "It couldn't have happened without telemedicine."
Kolodny is working with Sisley to bring her telemedicine services to West Virginia -- a partnership that was partially facilitated by a buprenorphine patient in that state.
Bondina Stone is a registered nurse in the rural Appalachian town of Mineral Wells, W.Va., which she says is mired in the OxyContin epidemic.
Stone's own struggle with addiction began after a 1993 accident that left her in severe pain. She was on and off painkillers for years, sometimes after unsuccessful attempts at treatment with methadone.
Finally, in 2008, she was able to get a prescription for buprenorphine.
"If changed my life," she told MedPage Today. "I'm productive now. I work, I'm a full-time mother. I can focus on what I need to do in life, rather than on how I am going to make it to the clinic tomorrow."
Her take on buprenorphine: "It makes you feel normal," unlike being on methadone, where "you still get a little high."
Carolyn Alfieri, a buprenorphine patient from Long Island, cautioned that successful treatment largely depends on the patient's own drive to stay clean. She had one unsuccessful run with buprenorphine, falling back to old habits after an old friend sent her a "package" in the mail.
But the second time was the charm for Alfieri, and she has now been opioid-free for two and a half years.
"In my opinion, buprenorphine is a lifesaver," she said. "I'm not panhandling, I'm not pawning my mother's wedding ring. I'm getting the trust of loved ones back."
Buprenorphine 'Its Own Worst Enemy'
That's not to say buprenorphine is without drawbacks.
"It is its own worst enemy," Reuter said, because in some cases it works so well that patients think they're "cured" and decide to stop taking it.
Addiction specialists say it's typically a long-term treatment, although the length varies from patient to patient, sometimes depending on how long they've been addicted. Alfieri said that some patients do complain about not being able to come off even a very low dose.
The company is also investigating an implantable version of the drug.
And the drug is not without risks. Even in France where the drug is credited with reducing both drug overdoses and injection drug use, when buprenorphine was introduced there was a simultaneous uptick in opioid-related deaths due to an unforeseen consequence of combining crushed, injected buprenorphine with benzodiazepines like diazepam (Valium) or excessive alcohol intake.
Since diversion was an anticipated concern, addiction specialists in the U.S. have favored Suboxone, a version of buprenorphine that contains naloxone (Narcan), an opioid antagonist, in a 4:1 ratio.
"If you crush it, the naloxone kicks in and sends you into horrible withdrawal, so you don't want to do it again," Levounis said.
Reuter said there was an increase in buprenorphine diversion in 2006 that has since leveled off. And the diversion rate with buprenorphine remains low compared with that of opioid analgesics.
Suboxone has also been diverted in a less expected way. Prescription painkiller addicts will sometimes attempt to acquire it themselves, in order to kick their habit.
The treatment, however, requires that the patient be in withdrawal before starting it.
Stone recalls the withdrawal she had to force upon herself before starting Suboxone. "That was a night I never want to remember again," she says. Her physician gave her his cellphone and talked her through making herself more comfortable, which eased the process.
"I felt much better after the first 24 hours on the drug," she said, "and then even better the next day."
She says she hasn't used prescription painkillers since, although she is still on Suboxone and plans to be for a while. She now has a career in nursing again, as a case manager for a firm in West Virginia.
And she wants others who are struggling in her community to know that they have hope too.