Oxytocin Treatment of Alcohol Withdrawal

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cort Pedersen, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01212185
First received: September 28, 2010
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Alcohol Withdrawal
Drug: intranasal oxytocin spray
Other: Other: formulated solution containing all ingredients as Syntocinon Spray except for oxytocin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxytocin Treatment of Alcohol Withdrawal

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Total number of bouts of withdrawal that require lorazepam treatment [ Time Frame: Days 1 to 5 ] [ Designated as safety issue: No ]
  • Total lorazepam (in milligrams) required per patient per admission [ Time Frame: Days 1 to 5 ] [ Designated as safety issue: No ]
  • Alcohol Withdrawal Scores (CIWA-Ar) [ Time Frame: Days 1 to 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-report ratings of alcohol withdrawal symptoms and mood [ Time Frame: Days 1 to 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control spray
Administration by research nurse twice daily of intranasal spray that does not contain oxytocin.
Other: Other: formulated solution containing all ingredients as Syntocinon Spray except for oxytocin
Treatment consists of 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days of a formulated solution that contains all ingredients in Syntocinon Spray except for oxytocin.
Experimental: oxytocin
Twice daily oxytocin treatments will be administered by research nurse
Drug: intranasal oxytocin spray
6 insufflations (24 IU of oxytocin total) given twice daily for 3 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212185

Locations
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Central Regional Hospital
Raleigh, North Carolina, United States, 27603
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Cort A Pedersen, M.D. The University of North Carolina, Chapel Hill, Department of Psychiatry
  More Information

Additional Information:
No publications provided

Responsible Party: Cort Pedersen, MD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01212185     History of Changes
Other Study ID Numbers: 09-0172
Study First Received: September 28, 2010
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
oxytocin
alcohol withdrawal
lorazepam
alcoholism
intranasal administration
CIWA-Ar

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014