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Psych Congress  

Use of Supportive Medication for Opioid Withdrawal Syndrome in a Randomized, Placebo-Controlled Trial of Lofexidine


Mark Pirner, MD, PhD – US WorldMeds, LLC; Thomas Clinch, MS – US WorldMeds, LLC

US WorldMeds

Introduction: Abrupt discontinuation of opioids after chronic use can result in severe, distressing symptoms that result from central noradrenergic hyperactivity. Avoidance of opioid withdrawal syndrome (OWS) can perpetuate opioid use in patients with opioid use disorder (OUD) despite the initial reason for using opioids. Lofexidine is an alpha2-adrenergic receptor agonist approved for mitigation of OWS in adults.

Methods: This was a double-blind, placebo-controlled study evaluating lofexidine 2.16 and 2.88 mg daily. Adults with opioid dependence were abruptly withdrawn from short-acting opioids prior to entering a 7-day treatment period. Use of protocol-specified supportive medications was analyzed during the double-blind period.

Results: A total of 602 subjects received lofexidine 2.16 mg (N=229); lofexidine 2.88 mg (N=222); or placebo (N=151). Supportive medications (acetaminophen, antacids, bismuth and zolpidem) occurred in a numerically greater proportion of placebo subjects (vs either lofexidine group) on Days 2-5 during peak OWS intensity. Proportions were 16% to 23% higher for acetaminophen and 8% to 19% higher for bismuth in the placebo group compared with the lofexidine groups.

Discussion: Use of supportive symptomatic withdrawal medications was greater in the placebo group compared with the lofexidine groups during peak withdrawal. Lofexidine effectively mitigates OWS symptoms that occur during early withdrawal, a critical period for OWS treatment and subsequent transition to OUD treatment.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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