Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches

Inclusion Criteria

• male or female 21 years or older.
• able to read, understand, and sign the informed consent.
• currently consume alcohol averaging at least four times per month.
• a negative urine pregnancy test at Visit 1, if female, and of childbearing potential. Note: If of childbearing potential, subject must agree to maintain true abstinence or use (or have their partner use) one of the listed methods of birth control for the duration of the study: hormonal contraceptive, intrauterine device (IUD), condoms, diaphragm, and/or vasectomy. The use of barrier contraceptive (condom or diaphragm) should always be supplemented with the use of a spermicide. Note: To be considered not of childbearing potential, subject must be 6 weeks post-surgical bilateral oophorectomy, hysterectomy, or bilateral tubal ligation, or postmenopausal for at least one year.
• at least a one year history of delayed alcohol-induced headache after light to moderate alcohol consumption.
• able to differentiate delayed alcohol-induced headache from any other headache they may experience (e.g., tension-type headache).
• able to stay awake for at least 2 hours after treatment following first dose of study product.
• willing to complete the online headache diary and questionnaires.
• concomitant medication dosages approved by the investigator.
• internet access and an email address for completion of online diary and questionnaires.

Exclusion Criteria

• > 6 migraine attacks per month during the 3 months previous to screening.
• history of receiving partial or complete relief of hangover headaches from 650 mg of aspirin.
• history of basilar, ophthalmoplegic, or hemiplegic migraine, cluster headache, or secondary headaches (such as due to trauma, infection, alterations of homeostasis, eye, nose, throat (ENT) disorders, or psychiatric disorders, cranial or cervical disorders or neuralgias) within the previous year.
• significant alcohol or drug use problems (score > 4 on the Simple Screening Instrument for Alcohol and Other Drugs (SSI-AOD)) or history of treatment or counseling for alcohol or drug abuse and or dependence.
• used acute headache medication including non-prescription medications, 15 or more days per month during the last 3 months.
• pregnant, actively trying to become pregnant, or breastfeeding.
• female of childbearing potential not using adequate contraceptive measures.
• has a history of serotonin syndrome or in the opinion of the investigator is at an increased risk for developing serotonin syndrome with the use of triptans.
• in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to hypertension, hypercholesterolemia, smoker, obesity, diabetes, or family history of coronary artery disease).
• if female, has migraine with aura, is a smoker, and currently taking estrogen containing birth control pill, and in the investigator's opinion, is at high risk for cerebrovascular disease.
• uncontrolled hypertension (≥140/90 mmHg in either systolic or diastolic in 2 out of 3 blood pressure measurements at screening).
• history of any clinically significant medical or psychiatric condition, or evidence of substance abuse including binge drinking within the last year that, in the opinion of the investigator, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this study.
• has hypersensitivity, intolerance, or contraindication to the use of any triptan or aspirin (including all sumatriptan and aspirin preparations).
• has history of nasal polyps and/or asthma and in the investigator's opinion is at risk for hypersensitivity to aspirin.
• participated in an investigational drug trial within the past 30 days.
• planning or requiring surgery during the study.
• history of poor compliance with medical treatm