Naltrexone and Acetaminophen Combination for Acute Migraine in Adults (AT-06)

The main objective of the study is to evaluate the safety and efficacy of an oral combination of naltrexone and acetaminophen for the treatment of acute migraine and co-morbid anxiety in adults.

Inclusion Criteria:Male or female ages 18 to 75 years, inclusiveAt least 1-year of history of migraine with or without aura as defined by the International Classification of Headache Disorders 3rd edition (ICHD-3)Migraine onset before age 50 yearsAble to not use opioids (including methadone and buprenorphine) during the study and for 7 days after taking the study medicationExclusion Criteria:Pregnant or nursing women or those planning a pregnancy.Use of opioids in the past 6 months.Use of medications to treat headache more than 10 days per month in the past 3 months.Use of barbiturate-containing medications, muscle relaxants, benzodiazepines, or marijuana in the past 6 months.Positive results for cocaine, marijuana, opiates, methamphetamines, and oxycodone in a urine drug screen.Symptoms consistent with chronic migraine, cranial neuropathy, and other pain syndromes.Headaches lasting more than 2 days in the past 3 months.More than one emergency care treatment for migraine in the past 12 months.BMI equal to or greater than 37 kg/m2.Uncontrolled cardiovascular or cerebrovascular disease or a recent history of heart failure, atrial fibrillation, or myocardial infarction.Uncontrolled hypertension or diabetes.Current diagnosis of major depression, schizophrenia, dementia, significant neurological disorders, or other pain syndromes.Gastric or small intestinal surgery or malabsorption and hepatic disease.Significant hematologic, endocrine, pulmonary, renal, or gastrointestinal disease or history of malignancy in the past 5 years.History of alcohol or drug abuse or current cannabis use in the past 12 months.Known allergy to naltrexone or acetaminophen.Participation in another clinical trial.Immediate family members or same household members participating in the study.Site personnel, their friends, and family. Paid referral fees are not allowed.Abnormal laboratory or ECG results such as bundle branch block, liver or kidney function tests, hemoglobin level, neutrophil count, cholesterol, or triglycerides.