title: A Pilot Study of the Safety and Initial Efficacy of Ivermectin for the Treatment of Alcohol Use Disorder.
abstract: Ivermectin (IVM) is an antiparasitic agent that has been shown to reduce alcohol intake in mice, suggesting IVM as a potential treatment for alcohol use disorder (AUD). However, the safety profile of IVM administered in combination with an intoxicating dose of alcohol has not been characterized in humans.
  
  
  
  This pilot project sought to provide the first clinical evidence that IVM could be repositioned as an AUD pharmacotherapy by examining (i) the safety of combining IVM (30 mg oral , once a day [QD]) with an intoxicating dose of intravenous alcohol (0.08 g/dl) and (ii) the effects of IVM on alcohol cue-induced craving and subjective response to alcohol. Eleven individuals with AUD participated in a randomized, placebo-controlled, crossover study in which they received the study medication, participated in a cue exposure paradigm followed by intravenous alcohol administration, and remained in an inpatient unit overnight for observation.
  
  
  
  IVM treatment, versus placebo, did not increase the number or severity of adverse effects during alcohol administration or throughout the visit. However, IVM did not reduce cue-induced craving nor did it significantly affect subjective response to alcohol.
  
  
  
  These results suggest that IVM (30 mg oral, QD) is safe in combination with an intoxicating dose of alcohol, but do not provide evidence that this dose of IVM is effective in reducing alcohol craving or its reinforcing effects. Given the preclinical data suggesting IVM is effective in reducing alcohol consumption in mice, additional studies testing larger samples and alternate dosing regimens are warranted to further characterize the potential efficacy of IVM as an AUD treatment.
authors.affiliation: Department of Psychology, University of California, Los Angeles, California.
authors.forename: Daniel J O
authors.initials: DJ
authors.lastname: Roche
authors.affiliation: Department of Psychology, University of California, Los Angeles, California.
authors.forename: Megan M
authors.initials: MM
authors.lastname: Yardley
authors.affiliation: Department of Psychology, University of California, Los Angeles, California.
authors.forename: Katy F
authors.initials: KF
authors.lastname: Lunny
authors.affiliation: Titus Family Department of Clinical Pharmacy, University of Southern California, Los Angeles, California.
authors.forename: Stan G
authors.initials: SG
authors.lastname: Louie
authors.affiliation: Titus Family Department of Clinical Pharmacy, University of Southern California, Los Angeles, California.
authors.forename: Daryl L
authors.initials: DL
authors.lastname: Davies
authors.affiliation: Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, California.
authors.forename: Karen
authors.initials: K
authors.lastname: Miotto
authors.affiliation: Department of Psychology, University of California, Los Angeles, California.|Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, California.
authors.forename: Lara A
authors.initials: LA
authors.lastname: Ray
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D019973:Alcohol-Related Disorders / Q000188:drug therapy*; D000977:Antiparasitic Agents / Q000009:adverse effects / Q000627:therapeutic use; D066249:Craving / Q000187:drug effects; D018592:Cross-Over Studies; D000431:Ethanol / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007559:Ivermectin / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012054:Reinforcement, Psychology; D055815:Young Adult
chemical_list: D000977:Antiparasitic Agents; D000431:Ethanol; D007559:Ivermectin
keywords: Alcohol Use Disorder; Medication Development; Pharmacokinetcs; Pharmacotherapy; Pilot Laboratory Study; Safety