Treatment with lofexidine may provide better control of the symptoms of opioid withdrawal syndrome (OWS) compared with placebo, according to research presented at Psych Congress 2019, held October 3 to 6 in San Diego, California.
Lofexidine is a non-opioid, centrally acting agonist of α2-adrenergic receptors that was approved by the United States Food and Drug Administration in May 2018 for the management of opioid withdrawal symptoms in adults. OWS, which refers to the severe symptoms associated with the abrupt interruption of chronic opioid use (eg, vomiting, pain, and anxiety), is caused by enhanced activity in the locus coeruleus resulting in excessive noradrenaline release from this structure.
In this double-blind placebo-controlled study, 602 patients aged ≥18 years with opioid use disorder who abruptly discontinued their short-acting opioid regimen were randomly assigned to receive lofexidine 2.16 mg/d (4 daily doses of 0.54 mg; n=229; 70.7% men; 73.8% white; 86.0% using heroin; mean substance use duration, 9.3 years), lofexidine 2.88 mg/d (4 daily doses of 0.72 mg; n=222; 71.2% men; 71.2% white; 82.0% using heroin; mean substance use duration, 7.9 years), or placebo (4 times/d; n=151; 70.9% men; 77.5% white; 80.8% using heroin; mean substance use duration, 8.8 years). The study outcome was the percentage of patients taking supportive medication for OWS as specified in the protocol (eg, acetaminophen, bismuth, antacids, and zolpidem) from day 1 to day 7.
A greater percentage of patients taking placebo vs either dose of lofexidine resorted to supportive medication from day 2 to day 5, with greater group differences for the use of acetaminophen and bismuth. Adverse events associated with the use of lofexidine included bradycardia, orthostatic hypotension, hypotension, and dizziness.
“Lofexidine effectively mitigates OWS symptoms during peak withdrawal, a critical period for OWS treatment and subsequent transition to [opioid use disorder] treatment,” concluded the study investigators.
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Disclosure: This study was supported by US WorldMeds, LLC. Both authors are employees of US WorldMeds, LLC.
Pirner M, Clinch T. Use of supportive medication for opioid withdrawal syndrome in a randomized, placebo-controlled trial of lofexidine. Presented at: Psych Congress 2019; October 3-6, 2019; San Diego, CA. Poster 242.