Oxytocin Treatment of Alcohol Withdrawal

This study has been completed.
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: April 12, 2014
Last verified: April 2014
  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: intranasal spray without 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 Lorazepam Dosage (in Milligrams) [ Time Frame: Days 1 to 5 ] [ Designated as safety issue: No ]
    Total lorazepam (in milligrams) required per subject to complete detoxification


Secondary Outcome Measures:
  • CIWA-Ar Scores [ Time Frame: days 1 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 14
Study Start Date: July 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 14, 2013
Last Updated: April 12, 2014
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 September 30, 2014