Opioid addiction treatments face off in U.S. trial

CHICAGO -- The first U.S. study to compare two treatments for opioid addiction finds a monthly shot works as well as a daily drug to prevent relapse.

The shot requires days of detox first, and that proved to be a stumbling block for many. For those who made it past that hurdle, the shot Vivitrol worked about the same as an older treatment, Suboxone.

Both drugs had high relapse rates and there were overdoses, including fatal ones, in the experiment in 570 adults. The study, published Tuesday in the journal Lancet, is the first to compare the two drugs in the United States, where an opioid addiction epidemic has doctors and policymakers divided over treatment strategies.

Many addiction treatment programs don't offer either medication, or only one of them.

"Let's not keep arguing about the exact batting averages of these two things," and make them more available, said study co-author Dr. Joshua Lee of New York University School of Medicine.

President Donald Trump recently declared the crisis a national public-health emergency. Overdoses, most involving prescription painkillers and other opioids, killed 64,000 people in the United States last year.

"Addiction medicine physicians are hungry to get data, especially from head-to-head comparisons like this one," said Dr. Joseph Garbely of Pennsylvania-based Caron Treatment Centers, who wasn't involved in the research.

A smaller Norwegian study, published last month, also found the two medications work equally well.

The new study recruited users of heroin and pain pills from eight detox centers across the United States. Half were assigned to get monthly shots of Vivitrol, which contains extended-release naltrexone. The others got daily Suboxone, a buprenorphine-naloxone combo in a film that dissolves under the tongue.

After six months of outpatient treatment, including voluntary counseling, 65 percent of the Vivitrol group had relapsed compared to 57 percent of the Suboxone group. Anyone who dropped out of the study was scored as having relapsed.

The difference in the groups stemmed almost entirely from patients who left during detox for Vivitrol. Twenty-eight percent dropped out before getting Vivitrol, compared to 6 percent who dropped out before a first dose of Suboxone.

Of those who actually started treatment, about half of both groups relapsed.

Vivitrol requires a patient to fully detox first because, if taken too soon, it can cause severe and sudden withdrawal symptoms. Suboxone can be started sooner, while patients still have mild withdrawal symptoms.

The researchers found no real difference in overdoses. There were five fatal overdoses, two in the Vivitrol group and three in the Suboxone group. There were 23 nonfatal overdoses, 16 in the Vivitrol group -- half of those in the dropouts who never received Vivitrol -- and seven in the Suboxone group.

The two medicines work differently, but both block the powerful high of addictive opioids. Treatment programs tend to favor one over the other. Those preferring Suboxone compare it to insulin for diabetes, but others see it as a crutch because it contains an opioid that has a mild effect on pain and mood. Suboxone costs about $100 a month. Vivitrol costs about $1,000 a month.

Methadone, a third treatment drug, was not part of the study. In the U.S., methadone must be given at special clinics. Any doctor can prescribe Vivitrol. Prescribers need special training and a waiver to prescribe Suboxone.

Vivitrol offers "a tremendous advantage" to rural patients who live far from the nearest methadone clinic or trained prescriber, said Dr. Nora Volkow, director of the National Institute on Drug Abuse, which sponsored the study.

"This study removes a barrier, the belief that (Vivitrol) was not as good a medication," she said.

Some people end up trying one medication, then another. Derek Ball got hooked on the prescription painkiller OxyContin after knee surgery at age 24. Five days on Suboxone helped him get off opioids. After two years clean, he relapsed at 30 and is trying again with Vivitrol.

"The detox period was excruciating," said Ball, 32, of Tifton, Georgia, who receives his third monthly shot of Vivitrol this week. "It's like somebody inside was screaming and on the outside I just looked fine."

Ball says Vivitrol is working for him, but adds family support, counseling and commitment are crucial. "If you solely rely on a medication, you're destined to fail."

Follow AP Medical Writer Carla K. Johnson on Twitter: (at)CarlaKJohnson