Oxytocin Treatment of Alcohol Dependence
Condition: Alcohol Withdrawal; Alcohol Dependence
MeSH terms: Alcoholism
Intervention: intranasal oxytocin spray; Intranasal Placebo Spray
Intervention description: Administration of oxytocin in a nasal spray; Intranasal Placebo Spray
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: oxytocin; alcohol withdrawal; alcohol dependence; alcoholism

Summary:

      This study will test in individuals who have alcohol dependence (alcohol addiction) the
      hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during
      medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the
      outpatient setting will decrease drinking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion Criteria for the inpatient phase (alcohol withdrawal treatment) of the study

             1. 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.

             3. 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.

             4. 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.

             5. 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)
             <.08 gm/dL (the consent process is repeated when the BAL level has dropped to 0.00
             gm/dL) and 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).

             6. Ability to get to appointments either through personal or public transportation.

          -  Inclusion 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.

          -  Inclusion Criteria for the outpatient phase of the study for prospective subjects
             recruited from the community and screened during an initial outpatient clinic visit
             The same criteria as those listed above for the inpatient alcohol withdrawal treatment
             phase of the study apply except for having a previous history of alcohol withdrawal
             (inclusion criterion #2)

        Exclusion Criteria:

          -  Exclusion Criteria for the inpatient alcohol withdrawal treatment phase of the study

               -  1. History of alcohol withdrawal-related seizures, delirium tremens or
                  hallucinations.

                  2. 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). Clinically significant psychiatric illnesses including any
                  psychotic disorder, bipolar disorder, eating disorder, severe depression, or
                  suicidal ideation.

                  3. Other substance dependence disorder with the exceptions of nicotine or
                  caffeine. Substance abuse disorders are not exclusionary.

               -  4. Chronic or subchronic ( >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).

                  6. AST or ALT (liver function tests) > 5 times ULN (upper level of normal),
                  bilirubin (liver function test) > 1.5 X ULN, sodium < 132 or > 150 mMol/L,
                  potassium < 3.2 or > 5.3 mMol/L.

                  7. 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.