Clinical trial: Computer-Assisted Self-Administration of Ethanol (NCT00713492)

Eligibility criteria:
-  GROUPS 1-5:

        All participants will be between the ages of 21 and 45 years, social drinkers in good
        health. Young females will have normal menstrual cycles and will be tested during the
        follicular phase of their cycle (within 10 days of offset of menses) and must have a
        negative urine pregnancy (hCG) test at the start of the study session.

        INCLUSION CRITERIA:

          1. Male and female participants between 21-45 years of age.

          2. Good health as determined by normal or non-clinically-significant findings on medical
             history, physical exam, ECG and lab tests.

          3. Female participants will be tested during the follicular phase of their cycle (within
             10 days of offset of menses) and must have a negative urine pregnancy (hCG) test at
             the start of each study session. For Group 5, due to the number of study visits,
             female subjects will be tested outside the menses phase of their cycle.

          4. Group 5 will include 20 subjects who report at least 2 binge drinking episodes in the
             month prior to the study (a binge episode is defined as consuming at least 4 drinks
             for females and at least 5 drinks for males during the drinking episode) and 20
             subjects

        who report no binge drinking episodes in the past month.

        EXCLUSION CRITERIA:

          1. Current or prior history of serious medical illness, including CNS, cardiovascular,
             respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.

          2. Positive hepatitis A, B antigen or C or HIV test at screening.

          3. Current history of Axis-I psychiatric illness.

          4. Current or lifetime diagnosis of alcohol or substance dependence.

          5. Currently seeking treatment for alcohol use disorders.

          6. History of significant withdrawal symptoms or presence of clinically significant
             withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at
             screening.

          7. Non-drinkers (alcohol-na(SqrRoot) ve individuals or current abstainers) or individuals
             with no experience drinking 5 or more drinks on one occasion in their lifetime.

          8. Regular tobacco users will be excluded from the study in order to avoid nicotine
             withdrawal symptoms. Occasional use of tobacco products (up to 20 cigarettes/week) is
             acceptable. For Groups 3, 4 and 5, participants must be current non-smokers (past
             smokers who have quit for over 1 year can be included).

          9. Positive result on urine drug screen or positive breathalyzer during screening visit
             or at the start of any study visit.

         10. Pregnancy or intention to become pregnant for women. Female participants will undergo
             a urine beta-hCG test to ensure they are not pregnant.

         11. Use of prescription or OTC medications known to interact with alcohol within 2 weeks
             of the study. These include, but may not be limited to: isosorbide, nitroglycerine,
             benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and
             nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide,
             H2-antagonists for heartburn such as cimetidine and

             ranitidine, muscle relaxants, anti-epileptics including phenytoin and phenobarbital
             codeine, and narcotics including propoxyphene, oxycodone and hydrocodone. Drugs known
             to inhibit or induce enzymes that metabolize alcohol should not be used for 4 weeks
             prior to the study. These include chlorzoxazone, isoniazid, metronidazole and
             disulfiram. Cough-and-cold preparations which contain anti-histamines, pain medicines
             and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib and
             naproxen, should be withheld for at least 72 hours prior to each study session.

         12. Current or prior history of alcohol-induced flushing reactions.

         13. Female participants who have abnormal menstrual cycles in the absence of
             irregularities caused by hormonal contraception, as defined by irregularities in
             menstrual cycle length (cycles of >36 days or < 8 cycles per year), clinically
             significant menstrual periods that are heavier or lighter than usual, and/or
             accompanied by significant pain, cramping or nausea and vomiting that requires
             intervention.

        GROUP 6

        Group 6 will include heavy drinkers between the ages of 21 and 60 years, in good health.
        Unfortunately, heavy drinking does not have a universally agreed upon definition and the
        criteria used to define heavy drinking vary from study to study. There is evidence that

        incorporating both amount of alcohol consumed per occasion and amount of alcohol consumed
        per week is relevant to account for risk related to pattern of drinking and total
        consumption. Therefore in our study we will select heavy drinkers using a definition that
        takes into account both pattern of drinking and total consumption. For pattern of drinking,
        we will require our subjects to have on average at least one binge drinking day per week,
        using the NIAAA definition of 5 or more drinks for men and 4 or more drinks for women
        (NIAAA website). For total consumption, we will use an average of 8 or more drinks per week
        for women and 15 or more drinks per week for men as this level of drinking has been shown
        to confer increased risk of mortality.

        INCLUSION CRITERIA:

          1. Male and female participants between 21-60 years of age.

          2. Male participants must have consumed an average of 15 or more standard drinks per week
             and females must have consumed an average of 8 or more standard drinks per week during
             the past 90 days. Average number of drinks per week will be calculated based on total
             number of drinks as measured by the timeline followback (TLFB) (e.g., for 90 days
             worth of data, total drinks divided by 90 and then multiplied by 7 will be the average
             number of drinks per week).

          3. Participants must have on average at least 1 binge drinking day per week during the
             last 90 days, defined as a day in which 4 or more standard drinks were consumed for
             females and 5 or more standard drinks were consumed for males. Average number of binge
             drinking days will be calculated based on total number of binge drinking days from the
             TLFB (e.g. for 90 days worth of data, participants with a total of 13 or more binge
             drinking days will be eligible).

          4. Participants must be able and willing to refrain from consuming alcohol 24 hours prior
             to each alcohol self-administration session.

        EXCLUSION CRITERIA:

          1. Current or prior history of serious medical illness, including CNS, cardiovascular,
             respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.

          2. Positive hepatitis A, B antigen, or C or HIV test at screening.

          3. Abnormal findings on ECG, unless cleared for participation by cardiologist or Licensed
             Independent Practitioner (LIP).

          4. Current history of major depressive disorder, bipolar disorder, psychotic disorder,
             obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), eating
             disorder, or any other Axis-I psychiatric disorders requiring intervention.

          5. An aspartate transaminase (AST) or alanine transaminase (ALT) level more than 3 times
             the upper limit of normal.

          6. Current (past 12 months) diagnosis of substance use disorder other than alcohol use
             disorder, unless in early remission (no criteria met for at least 3 months).

          7. Positive result on urine drug screen or breathalyzer test during initial or update
             visit under the screening protocol (14-AA-0181) most proximal to enrollment. Positive
             urine drug screen during more than 1 study visit or breathalyzer reading during more
             than 1 self-administration study visit will result in participant withdrawal from the
             study.

          8. Currently seeking treatment for alcohol use disorder or having undergone inpatient or
             outpatient detoxification or treatment for alcohol problems in the past 6 months.

          9. History of significant withdrawal symptoms or presence of clinically significant
             withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at
             screening.

         10. Pregnancy, intention to become pregnant, or breastfeeding. Female participants will
             undergo a urine beta-hCG test to ensure that they are not pregnant.

         11. Medication exclusion criteria:

               1. . Daily or regular use of prescription or OTC medications known to interact with
                  alcohol in the 2-week period prior to assessment. These include, but may not be
                  limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin,
                  anti-depressants such as amitriptyline, clomipramine and nefazodone,
                  anti-diabetes medications such as glyburide, metformin and tolbutamide,
                  H2-antagonists for heartburn such as cimetidine and ranitidine, muscle relaxants,
                  anti-epileptics including phenytoin and phenobarbital codeine, and narcotics
                  including propoxyphene, oxycodone and hydrocodone.

               2. Daily or regular use of drugs known to inhibit or induce enzymes that metabolize
                  alcohol in the 4-week period prior to assessment. These include chlorzoxazone,
                  isoniazid, metronidazole and disulfiram. Note that any discontinuation of
                  medications will only be done at the recommendation of a physician.

         12. Current or prior history of alcohol-induced flushing reactions.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 1