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Trial · Interventional

CompletedPhase 1Results postedRegistry data

Oxytocin Treatment of Alcohol Withdrawal

Overview

Status
Completed
Phase
Phase 1
Enrollment
14 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Jul 2010
Primary completion
Mar 2011
Completion
Mar 2011
First posted
30 Sept 2010 (estimated)
Last update posted
13 May 2014 (estimated)
Conditions
Alcohol Withdrawal

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 1

    Oxytocin Treatment of Alcohol Withdrawal

    NCT01212185

    Jul 2010 to Mar 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • intranasal oxytocin sprayDrug
  • intranasal spray without oxytocinOther

Arms2

  • Placebo comparator

    intranasal spray without oxytocin

    Twice daily intranasal spray without oxytocin.

  • Experimental

    intranasal oxytocin spray

    Twice daily intranasal oxytocin spray

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total Lorazepam Dosage (in Milligrams)

    Time frame · Days 1 to 5

    Registry description

    Total lorazepam (in milligrams) required per subject to complete detoxification

Secondary outcomes(1)
  1. CIWA-Ar Scores

    Time frame · days 1

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Days 1 to 5

Total Lorazepam Dosage (in Milligrams)

GroupValue (milligrams of lorazepam)Spread
Intranasal Spray Without Oxytocin16.54.4
Intranasal Oxytocin Spray3.44.7
Secondary and other outcome results(1)
Secondary outcomeMean· days 1

CIWA-Ar Scores

GroupValue (units on a scale)Spread
Intranasal Spray Without Oxytocin11.80.4
Intranasal Oxytocin Spray4.32.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Intranasal Spray Without OxytocinTwice daily intranasal spray without oxytocin. intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily–0 / 60 / 6
Intranasal Oxytocin SprayTwice daily intranasal oxytocin spray intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days–0 / 80 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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).

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