Status:
COMPLETED
Oxytocin Treatment of Alcohol Withdrawal
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Alcohol Withdrawal
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 t...
Detailed Description
Study Design: This will be a double-blind, placebo controlled comparison of the efficacy of twice daily intranasal administration of oxytocin and placebo (saline) in reducing alcohol withdrawal sympto...
Eligibility Criteria
Inclusion
- 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:
- At least one prior episode 2 days or longer in duration which the subject experienced withdrawal symptoms that caused significant incapacitation.
- 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
- 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).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01212185
Start Date
July 1 2010
End Date
March 1 2011
Last Update
May 13 2014
Active Locations (2)
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1
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
2
Central Regional Hospital
Raleigh, North Carolina, United States, 27603