Introduction is different, but top medications for opioid addiction equally effective

November 14, 2017, NYU Langone Health
Research from NYU School of Medicine, led by John Rotrosen, MD (left), from the Department of Psychiatry, and Joshua D. Lee, MD, MSc, from the Department of Population Health, examined in a head-to-head study two popular medications to treat opioid addiction. Credit: NYU Langone Health

With opioid addiction officially declared a public health emergency in the U.S., medical intervention to treat the illness is increasingly important in responding to the epidemic. Now, a new study concludes that two of the top medications available for outpatient, office-based treatment, once initiated, are equally safe and effective in curtailing opioid use, relapse, treatment drop-out and overdose.

Researchers in the Departments of Psychiatry and Population Health at NYU School of Medicine, who led the study sponsored by the National Institute on Drug Abuse (NIDA) and published online November 14, 2017 in The Lancet, conclude that extended-release naltrexone (an opioid antagonist marketed as Vivitrol) demonstrated similar safety and clinical effectiveness to more commonly prescribed buprenorphine-naloxone (an opioid agonist marketed both generically and as Suboxone).

However, the study also points out differences that have previously been known: Patients being treated with naltrexone must detoxify before it can be administered. (This is commonly referred to as the "detox hurdle.") On the other hand, buprenorphine allows individuals to transition relatively seamlessly from opioid use to medication maintenance without needing to detoxify.

Agonist (buprenorphine) and antagonist (naltrexone) treatment are pharmacologically, conceptually and logistically near-opposites—allowing patients, families and providers to choose an approach in line with their goals and preferences. Among the differences:

  • Agonists activate opioid receptors, have opioid-like effects, and maintain physical dependence on opioids, while antagonists have no effects on their own and block the effects of opioids
  • Agonists can be started while a patient is still opioid dependent or detoxifying, but antagonists only can be administered after full detoxification to avoid opioid withdrawals
  • When discontinued, agonists are associated with withdrawal symptoms; antagonists are not
  • Agonists have abuse potential and diversion risks; antagonists do not
  • There are differences in prescribing regulations and community acceptance between the two forms of treatment

Despite these differences, the researchers say, until now there had been no comparative data on the effectiveness of both treatments. "As the epidemic has escalated, and hundreds of people in the U.S. and elsewhere are dying every day, there is an increased urgency to provide immediate and effective medical treatment," says John Rotrosen, MD, professor in the Department of Psychiatry at NYU School of Medicine and the study's senior author. "Our findings should dispel some commonly held misconceptions and help patients choose between these different approaches to treatment."

Co-investigator Joshua D. Lee, MD, MSc, from the Department of Population Health at NYU School of Medicine, describes research examining in a head-to-head study two popular medications to treat opioid addiction. Credit: NYU Langone Health
What the Study Examined

The clinical trial took place from 2014 to 2017 at eight community treatment programs affiliated with NIDA's Clinical Trials Network across the U.S. The patient cohort involved 570 opioid dependent adults, approximately two-thirds of whom were men and 82% primarily using heroin. They were recruited during admission for detoxification and randomly assigned to two study groups for up to 24 weeks of treatment. One group received a monthly injection of naltrexone initiated after completing detoxification, and the other self-administered a daily oral dose of buprenorphine initiated as early as possible after randomization.

Among those treated, 24-week relapse rates were similar—52% for naltrexone and 55.6% for buprenorphine, as were other measures of opioid use. In addition, craving for opioids was lower with naltrexone, though by the end of 24 weeks, the buprenorphine group had caught up. Other than mild to moderate injection site reactions with naltrexone, adverse events, including fatal and non-fatal overdoses, were similar across the two study groups.

The study also examined the detox hurdle—a critical point of initiation for active users (though a non-issue for those who are already fully detoxed). Approximately 25% of participants assigned to the naltrexone group were unable to complete detox and get a first dose of naltrexone—though for those assigned to naltrexone later in the detox process, the hurdle wasn't so insurmountable. In contrast, only 6%, of patients were unable to start buprenorphine.

The study could have immediate implications for how the U.S. responds to a crisis that has already claimed 300,000 lives since 2000, according to the U.S. Centers for Disease Control and Prevention.

"Both medications are effective treatments for opioid use disorders versus counseling-only approaches or compared to placebo," says Joshua D. Lee, MD, MSc, associate professor in the Departments of Medicine and Population Health at NYU School of Medicine and the study's lead author. "What is now clear is how similar the outcomes are for those initiating treatment with either medication."

The researchers also point out that the study sheds light on the likelihood that those dropping out of detox will rapidly relapse. "Patients wanting naltrexone, but who are unable to complete detox," Lee adds, "should be encouraged to start an agonist-based treatment like buprenorphine."

A smaller (total cohort of 159 patients) and shorter (up to 12 weeks of treatment) parallel study conducted in Norway over the same period found naltrexone and buprenorphine to be equally effective in retaining patients in treatment and reducing opioid use. However, all participants in that study were randomized late in detox so there was no "hurdle" to clear. Prior to these two studies, the field had no comparative effectiveness data. An earlier multi-site clinical trial led by NYU School of Medicine found in 2016 that extended-release Naltrexone was effective at preventing opioid relapse in criminal justice offenders.

Explore further: Extended-release naltrexone promising for opioid dependence

More information: "Medications for opioid use disorder: bridging the gap in care," The Lancet (2017). www.thelancet.com/journals/lan … ulltext?elsca1=tlxpr

Related Stories

Extended-release naltrexone promising for opioid dependence

October 19, 2017
(HealthDay)—Extended-release naltrexone is noninferior to buprenorphine-naloxone for maintaining short-term abstinence from heroin and other illicit substances, according to a study published online Oct. 18 in JAMA Psychiatry.

Medicaid patients continue high prescription opioid use after overdose

August 22, 2017
Despite receiving medical attention for an overdose, patients in Pennsylvania Medicaid continued to have persistently high prescription opioid use, with only slight increases in use of medication-assisted treatment, according ...

Clinical trial looks at tramadol for opioid withdrawal

July 12, 2017
A randomized clinical trial published by JAMA Psychiatry compared tramadol extended-release with clonidine and buprenorphine for the management of opioid withdrawal symptoms in patients with opioid use disorder in a residential ...

Long-acting treatment for opioid addiction reduced risk of relapse

March 30, 2016
In a multicenter, randomized clinical trial, ex-prisoners who received six monthly injections of naltrexone—a long-acting medication that blocks opioid receptors in the brain—were significantly less likely to resume opioid ...

Medications underutilized when treating young people with opioid use disorder

June 19, 2017
Only one in four young adults and teens with opioid use disorder (OUD) are receiving potentially life-saving medications for addiction treatment, according to a new Boston Medical Center (BMC) study published online in JAMA ...

Study examines opioid agonist therapy use in Medicare patients

July 20, 2016
Few Medicare enrollees appear to be receiving buprenorphine-naloxone, the only opioid agonist therapy for opioid addiction available through Medicare Part D prescription drug coverage, according to a study published online ...

Recommended for you

Rapid response inpatient education boosts use of needed blood-thinning drugs

November 16, 2018
A new study designed to reach hospitalized patients at risk shows that a "real-time" educational conversation, video or leaflet can lower the missed dose rates of drugs that can prevent potentially lethal blood clots in their ...

Drug overdose epidemic goes far beyond opioids, requires new policies

November 7, 2018
Most government-funded initiatives to address the overdose epidemic in the United States have targeted opioids specifically and have neglected other drugs that are increasingly implicated in overdoses, such as cocaine and ...

Zebrafish larvae help in search for appetite suppressants

November 2, 2018
Researchers at the University of Zurich and Harvard University have developed a new strategy in the search for psychoactive drugs. By analyzing the behavior of larval zebrafish, they can filter out substances with unwanted ...

FDA OKs powerful opioid pill as alternative to IV painkiller

November 2, 2018
U.S. regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.

Amphetamine-related hospitalizations surged between 2003 and 2015

November 2, 2018
An analysis conducted by Hennepin Healthcare, University of Minnesota School of Public Health and University of Michigan researchers shows amphetamine-related hospitalizations increased more than 270 percent from 2008 to ...

Cocaine-fentanyl overdoses underscore need for more 'test strips' and rapid response

November 1, 2018
Penn Medicine emergency department physicians are calling for more readily available testing strips to identify the presence of fentanyl in patients experiencing a drug overdose, and a rapid, coordinated response among health ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.