Oxytocin Treatment of Alcohol Dependence

Inclusion Criteria

• Inclusion Criteria for the inpatient phase (alcohol withdrawal treatment) of the study
• Meeting criteria for DSM-IV (Diagnostic and Statistical Manual-IV-TR) alcohol dependence.

*2. At least one prior episode of DSM-IV alcohol withdrawal as assessed by SCID Alcohol Dependence Module or scoring > 6 on the CIWA scale since admission to the inpatient unit, or having any of the following elevated vital signs since admission: pulse > 110; diastolic blood pressure > 100; systolic blood pressure > 160.

• At least 12 heavy drinking days in the 28 days prior to enrollment in the study. A heavy drinking day is defined as >5 standard drinks for men or >4 standard drinks for women.
• Women who are able to conceive children must be on an effective form of birth control such as oral contraceptives, intrauterine devices 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) 3 days in the week prior to admission or outpatient enrollment) treatment with/consumption of benzodiazepines, barbiturates, anticonvulsants or stimulants.
• 5. Receipt of >6 mg of lorazepam or any dose of a long half-life benzodiazepine between admission for medical detoxification and beginning participation in the study (i.e., receiving the first intranasal dose of test treatment).
• AST or ALT (liver function tests) > 5 times ULN (upper level of normal), bilirubin (liver function test) > 1.5 X ULN, sodium 150 mMol/L, potassium 5.3 mMol/L.
• Women who are pregnant or breastfeeding. 8. Intent to participate in an additional alcohol treatment program other than Alcoholics Anonymous 9. Court-mandated participation in alcohol treatment or pending incarceration.
• Exclusion Criteria for the outpatient phase of the study (treatment of heavy drinking) for prospective subjects screened toward the end of their FRH or UNC inpatient stay The same criteria as those listed above for the inpatient phase of the study apply except for the criteria marked with an asterisk.