Oxytocin Treatment of Alcohol Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212185
Recruitment Status : Completed
First Posted : September 30, 2010
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):
Cort Pedersen, MD, University of North Carolina, Chapel Hill

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 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 or disease Intervention/treatment Phase
Alcohol Withdrawal Drug: intranasal oxytocin spray Other: intranasal spray without oxytocin Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxytocin Treatment of Alcohol Withdrawal
Study Start Date : July 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Placebo Comparator: intranasal spray without oxytocin
Twice daily intranasal spray without oxytocin.
Other: intranasal spray without oxytocin
6 insufflations (0.1 metered dose/insufflation) twice daily

Experimental: intranasal oxytocin spray
Twice daily intranasal oxytocin spray
Drug: intranasal oxytocin spray
6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
Other Name: Syntocinon Spray

Primary Outcome Measures :
  1. Total Lorazepam Dosage (in Milligrams) [ Time Frame: Days 1 to 5 ]
    Total lorazepam (in milligrams) required per subject to complete detoxification

Secondary Outcome Measures :
  1. CIWA-Ar Scores [ Time Frame: days 1 ]
    Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212185

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
Principal Investigator: Cort A Pedersen, M.D. The University of North Carolina, Chapel Hill, Department of Psychiatry

Additional Information:
Responsible Party: Cort Pedersen, MD, Professor, University of North Carolina, Chapel Hill Identifier: NCT01212185     History of Changes
Other Study ID Numbers: 09-0172
First Posted: September 30, 2010    Key Record Dates
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014
Last Verified: April 2014

Keywords provided by Cort Pedersen, MD, University of North Carolina, Chapel Hill:
alcohol withdrawal
intranasal administration

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Reproductive Control Agents