Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches
Condition: Delayed Alcohol Induced Headache
MeSH terms: Headache
Intervention: VVD-101; Placebo
Intervention description: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.; All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
Intervention MeSH terms: Aspirin; Sumatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Delayed Alcohol Induced Headache

Summary:

      This study proposes to compare the efficacy of sumatriptan and aspirin to placebo as an acute
      abortive treatment for delayed alcohol induced headache in adult subjects.
    

Eligibility criteria:

        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 treatment.