Oxytocin Treatment of Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Intranasal Oxytocin; Placebo
Intervention description: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks; 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcohol dependence; Alcohol; Oxytocin; Intranasal administration

Summary:

      Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming
      alcohol heavily for long periods and are physically and psychologically dependent on alcohol.

      Participants: 50 adults with alcohol dependence

      Procedures (methods): Oxytocin or placebo will be administered three times a day for the
      first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before,
      during and at the end of the trial, each subject will undergo evaluations including
      breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol
      consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at
      some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use.
      Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks
      to evaluate for post-medication safety and efficacy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meeting criteria for DSM-IV-TR alcohol dependence.

          -  Consumption of at least 35 standard drinks/week for men or 28 standard drinks/week for
             women for at least 4 consecutive weeks prior to enrollment into the study.

          -  Women who are able to conceive children and who are sexually active must be on an
             effective form of birth control such as oral contraceptives, IUDs or the use of
             condoms with spermicide.

          -  Competency to give valid informed consent as indicated by a) a Breathalyzer reading at
             the time the consent form is signed showing an estimated blood alcohol level (BAL) of
             zero; b) ability to understand the written informed consent form demonstrated by
             correctly answering questions about the contents of the form after reading the consent
             form without help (this will also determine whether prospective subjects can read and
             understand the study questionnaires).

          -  Ability to get to appointments either through personal or public transportation.

          -  Ages 18-65.

        Exclusion Criteria:

          -  History of alcohol withdrawal-related seizures, delirium tremens or hallucinations.

          -  Clinically significant medical disease that might interfere with the evaluation of the
             study medication or present a safety concern (e.g., renal insufficiency, cirrhosis,
             unstable hypertension, unstable diabetes mellitus, seizure disorder).

          -  History of psychotic disorder or admission for mania, meeting criteria for an eating
             disorder in the last 2 years, current moderate or severe major depression, current
             suicidal ideation.

          -  Currently meeting DSM-IV TR criteria for dependence on addictive substances other than
             alcohol except for nicotine or caffeine. Substance abuse disorders are not
             exclusionary.

          -  Consumption during the week prior to enrollment or plans to consume during the 12-week
             trial of benzodiazepines, barbiturates, anticonvulsants or stimulants.

          -  AST or ALT > 5 times ULN, bilirubin > 1.5 X ULN, sodium < 132 or > 150 mMol/L,
             potassium < 3.2 or > 5.3 mMol/L.

          -  Women who are pregnant or breastfeeding.

          -  Currently participating in or intent to participate in an additional alcohol treatment
             program during the study period other than Alcoholics Anonymous.

          -  Court-mandated participation in alcohol treatment or pending incarceration.