Oxytocin Treatment of Alcohol Withdrawal
Condition: Alcohol Withdrawal
Intervention: intranasal oxytocin spray; intranasal spray without oxytocin
Intervention description: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days; 6 insufflations (0.1 metered dose/insufflation) twice daily
Intervention MeSH terms: Oxytocin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oxytocin; alcohol withdrawal; lorazepam; alcoholism; intranasal administration; CIWA-Ar

Summary:

      Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective
      in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring
      standard medication treatment (lorazepam) and the amount of lorazepam required to control
      withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of
      subject recruitment and retention in the inpatient setting.

      Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical
      detoxification.

      Procedures (methods): Subjects will be inpatients undergoing medical detoxification from
      alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a
      randomized, double blind manner for three days. Withdrawal symptoms will be measured
      routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever
      withdrawal symptoms increase above specific parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Daily consumption of 6 or more alcohol drinks/day for at least 2 weeks prior to
             admission.

          -  Only one of the following two conditions must be met:

               1. At least one prior episode 2 days or longer in duration which the subject
                  experienced withdrawal symptoms that caused significant incapacitation.

               2. At least one prior inpatient or outpatient medical detoxification during which
                  the subject exhibited withdrawal symptoms that sedative-hypnotic or
                  anticonvulsant medication was required at least once on 2 consecutive days after
                  cessation of or reduction in the use of alcohol following 2 weeks or more of
                  heavily daily consumption (6 or more drinks/day).

        Exclusion Criteria:

          -  Low literacy as indicated by an inability to read and understand the consent form.

          -  Dependence on substances other than alcohol, nicotine, caffeine or cannabis.

          -  History of alcohol withdrawal-related seizures, delirium tremens or hallucinations.

          -  Current or past alcohol-related medical complications (e.g. cirrhosis of the liver,
             esophageal varices, severe gastritis, hemoptysis, hematochezia or melena).

          -  Current delirium, disorientation to place or persons, seizures, acute or unstable
             psychosis or mania.

          -  Suicidal or homicidal ideation with strong intent, plans or recent attempt.

          -  Debilitating medical conditions (including AIDS, seizure disorder, emphysema, cancer
             and not well-controlled diabetes/hypertension) [HIV infection, diabetes, hypertension
             and asthma will not be grounds for exclusion]

          -  Diagnosis of amnesia, dementia, cognitive impairment or significant neurological
             symptoms.

          -  Low body weight (BMI<17).

          -  History of anorexia nervosa or bulimia in the past 2 years.

          -  Significant trauma, self injurious behavior or surgery in the previous 2 months

          -  Pregnancy; giving birth or breast-feeding in the past 6 months.

          -  Ingestion during the 2 weeks prior to this admission of much more alcohol/day than
             during previous drinking binges that preceded the onset of alcohol withdrawal
             symptoms.

          -  Ingestion of more than 450 ml of alcohol/day.

          -  Chronic treatment with benzodiazepines, barbiturates, anticonvulsants or stimulants

          -  Treatment/ingestion in the 72 hours prior to enrollment in the study with long
             half-life benzodiazepines or sedative hypnotic drugs.

          -  A blood alcohol level upon admission > 300 mg/dl.

          -  Well-documented history of inadequately treated baseline hypertension or tachycardia
             (SBP>150 or DBP>100 or P>110).