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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin Treatment of Alcohol Dependence

Short name OT-ETOH2

Overview

Status
Completed
Phase
Phase 2
Enrollment
13 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Randomized · Quadruple masking
Countries
Not stated
Start
Jan 2013
Primary completion
Dec 2013
Completion
Mar 2014
First posted
27 Oct 2014 (estimated)
Last update posted
4 Apr 2017
Conditions
Alcohol Withdrawal · Alcohol Dependence

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 2

    OT-ETOH2

    NCT02275611

    Jan 2013 to Mar 2014

Registry summary

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

This study will test in individuals who have alcohol dependence (alcohol addiction) the hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the outpatient setting will decrease drinking.

Interventions

  • intranasal oxytocin sprayDrug
  • Intranasal Placebo SprayDrug

Arms2

  • Active comparator

    Intranasal oxytocin spray (Syntocinon Spray)

    TID inpatient; BID outpatient for 12 wks

  • Placebo comparator

    Intranasal Placebo Spray

    TID inpatient; BID outpatient for 12 wks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score

    Time frame · Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments

    Registry description

    The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).

Secondary outcomes(2)
  1. Total mg of Lorazepam for Detoxification

    Time frame · 48 hours after initiation of intranasal test doses

    Registry description

    Cumulative lorazepam received (2 mg doses) After initiation of test treatments, CIWA scores and vital signs were obtained every 4 hours or whenever subjects or staff reported/observed significant increases in symptoms. Lorazepam (2 mg dose) was given if CIWA scores were \>7, diastolic blood pressure rose to \>120, or heart rate rose to \>110. An additional 2 mg was given 1 hour after each lorazepam dose if CIWA scores and/or vital signs remained elevated.

  2. Change in Percentage Heavy Drinking Days

    Time frame · 90 days prior to admission and 4 weeks in the outpatient setting

    Registry description

    A heavy drinking day is defined by consumption of 5 or more standard drinks for men, 4 or more standard drinks for women. The outcome measure is the change in percentage of heavy drinking days as determine by the Timeline Followback interview between the baseline 90 day period and the first 4 weeks of intranasal test treatment in the outpatient setting.

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· Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments

Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score

GroupValue (units on a scale)Spread
Intranasal Oxytocin Spray (Syntocinon Spray)-2.761.95
Intranasal Placebo Spray1.011.62
Secondary and other outcome results(2)
Secondary outcomeMean· 48 hours after initiation of intranasal test doses

Total mg of Lorazepam for Detoxification

GroupValue (cumulative lorazepam doses (mg))Spread
Intranasal Oxytocin Spray (Syntocinon Spray)2.251.26
Intranasal Placebo Spray5.252.5
Secondary outcomeMean· 90 days prior to admission and 4 weeks in the outpatient setting

Change in Percentage Heavy Drinking Days

GroupValue (percentage of heavy drinking days change)Spread
Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)-0.3770.28
Outpatient Treatment Placebo Spray-0.9720.032

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Intranasal Oxytocin Spray (Syntocinon Spray)Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray: Administration of oxytocin in a nasal spray0 / 50 / 50 / 5
Intranasal Placebo SprayPlacebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray: Administration of oxytocin in a nasal spray Intranasal Placebo Spray: Intranasal Placebo Spray0 / 40 / 40 / 4
Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)2 daily doses intranasal oxytocin spray for 12 weeks0 / 60 / 60 / 6
Outpatient Treatment Placebo Spray2 daily doses intranasal placebo spray for 12 weeks0 / 30 / 30 / 3

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
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Inclusion Criteria for the inpatient phase (alcohol withdrawal treatment) of the study 1\. Meeting criteria for DSM-IV (Diagnostic and Statistical Manual-IV-TR) alcohol dependence. \*2. At least one prior episode of DSM-IV alcohol withdrawal as assessed by SCID Alcohol Dependence Module or scoring \> 6 on the CIWA scale since admission to the inpatient unit, or having any of the following elevated vital signs since admission: pulse \> 110; diastolic blood pressure \> 100; systolic blood pressure \> 160. 3\. At least 12 heavy drinking days in the 28 days prior to enrollment in the study. A heavy drinking day is defined as \>5 standard drinks for men or \>4 standard drinks for women. 4\. Women who are able to conceive children must be on an effective form of birth control such as oral contraceptives, intrauterine devices or the use of condoms with spermicide. 5\. Competency to give valid informed consent as indicated by a) a breathalyzer reading at the time the consent form is signed showing an estimated blood alcohol level (BAL) \<.08 gm/dL (the consent process is repeated when the BAL level has dropped to 0.00 gm/dL) and b) ability to understand the written informed consent form demonstrated by correctly answering questions about the contents of the form after reading the consent form without help (this will also determine whether prospective subjects can read and understand the study questionnaires). 6\. Ability to get to appointments either through personal or public transportation. * Inclusion Criteria for the outpatient phase of the study (treatment of heavy drinking) for prospective subjects screened toward the end of their FRH or UNC inpatient stay The same criteria as those listed above for the inpatient phase of the study apply except for the criteria marked with an asterisk. * Inclusion Criteria for the outpatient phase of the study for prospective subjects recruited from the community and screened during an initial outpatient clinic visit The same criteria as those listed above for the inpatient alcohol withdrawal treatment phase of the study apply except for having a previous history of alcohol withdrawal (inclusion criterion #2) Exclusion Criteria: * Exclusion Criteria for the inpatient alcohol withdrawal treatment phase of the study * 1\. History of alcohol withdrawal-related seizures, delirium tremens or hallucinations. 2\. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, unstable diabetes mellitus, seizure disorder). Clinically significant psychiatric illnesses including any psychotic disorder, bipolar disorder, eating disorder, severe depression, or suicidal ideation. 3\. Other substance dependence disorder with the exceptions of nicotine or caffeine. Substance abuse disorders are not exclusionary. * 4\. Chronic or subchronic ( \>3 days in the week prior to admission or outpatient enrollment) treatment with/consumption of benzodiazepines, barbiturates, anticonvulsants or stimulants. * 5\. Receipt of \>6 mg of lorazepam or any dose of a long half-life benzodiazepine between admission for medical detoxification and beginning participation in the study (i.e., receiving the first intranasal dose of test treatment). 6\. AST or ALT (liver function tests) \> 5 times ULN (upper level of normal), bilirubin (liver function test) \> 1.5 X ULN, sodium \< 132 or \> 150 mMol/L, potassium \< 3.2 or \> 5.3 mMol/L. 7\. Women who are pregnant or breastfeeding. 8. Intent to participate in an additional alcohol treatment program other than Alcoholics Anonymous 9. Court-mandated participation in alcohol treatment or pending incarceration. * Exclusion Criteria for the outpatient phase of the study (treatment of heavy drinking) for prospective subjects screened toward the end of their FRH or UNC inpatient stay The same criteria as those listed above for the inpatient phase of the study apply except for the criteria marked with an asterisk.

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