This article is more than 5 years old. Information may no longer be current.

Opioid abuse treatment medications equally effective

Buprenorphine-naloxone combination and extended-release naltrexone were both safe and effective in managing patients with opioid use disorder, yielding nearly identical results, according to findings recently published in The Lancet.

“Previous opioid antagonist or agonist comparisons have evaluated oral naltrexone and long-term naltrexone implants, but not monthly extended-release naltrexone treatment,” Joshua D. Lee, MD, department of population health, New York University School of Medicine, and colleagues wrote. “Important clinical issues remain unanswered, beyond the established efficacy of either extended-release naltrexone or buprenorphine-naloxone.”

Researchers conducted a 24-week, open-label, randomized, controlled, comparative effectiveness trial. Patients received either extended-release naltrexone via a monthly- intramuscular injections totaling 4 mL, or buprenorphine-naloxone via a daily self-administered sublingual film of either 4 mg/1 mg or 8 mg/2 mg strength. Most patients were actively using heroin at study baseline and all had used nonprescribed opioids in the past 30 days. Of the 570 intention-to-treat patients, 474 were successfully inducted into their respective 24 weeks of outpatient therapy, with 204 utilizing the extended-release naltrexone.

The primary outcome was time to relapse, which was defined as any nonstudy opioid after day 20 following randomization, either self-reported or by urine test,. Secondary outcomes were the proportion of participants successfully inducted onto a first dose of study medication, adverse events, frequency of nonstudy opioid use per Timeline Followback and assessment of weekly urine toxicology samples, and self-rated opioid cravings.

Lee and colleagues found that among participants successfully inducted, 24-week relapse events were similar across both groups . Conversely, 24-week relapse events occurred more frequently in patients receiving extended-release naltrexone than in those receiving sublingual buprenorphine-naloxone (HR = 1.36; 95% CI, 1.1–1.68) among the intent-to-treat population.

Other findings included:

• opioid-abstinent days and opioid-negative urine samples (both P <.0001) were more common in buprenorphine-naloxone recipients among the intention-to-treat population but were nearly identical across both study groups in the per-protocol population;
• self-reported opioid cravings were initially less with the extended-release naltrexone group (P = .0012), but both groups converged by week 24; and
• with the exception of mild-to-moderate injection site reactions, serious adverse events did not differ between treatment groups among the extended-release naltrexone group.

“Studies show that people with opioid dependence who follow detoxification with no medication are very likely to return to drug use, yet many treatment programs have been slow to accept medications that have proven to be safe and effective,” Nora D. Volkow, MD, director of the National Institute for Drug Abuse, said in a press release. “These findings should encourage clinicians to use medication protocols.”

“Our findings should dispel some commonly held misconceptions and help patients choose between these different approaches to treatment,” John Rotrosen, MD, study co-author and professor, department of psychiatry, New York University School of Medicine, added in a separate press release. – by Janel Miller

Disclosures: Lee reports receiving research funding from the National Institute for Drug Abuse. Please see the study for all other authors’ relevant financial disclosures.