Oxytocin Treatment of Alcohol Withdrawal

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Ethanol; Oxytocin

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).