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Oxytocin Treatment of Alcohol Dependence (OTETOH-3)

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.
 
ClinicalTrials.gov Identifier: NCT02251912
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming alcohol heavily for long periods and are physically and psychologically dependent on alcohol.

Participants: 50 adults with alcohol dependence

Procedures (methods): Oxytocin or placebo will be administered three times a day for the first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before, during and at the end of the trial, each subject will undergo evaluations including breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use. Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks to evaluate for post-medication safety and efficacy


Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Intranasal Oxytocin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial
Actual Study Start Date : July 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Active
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Drug: Intranasal Oxytocin
10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
Other Name: Syntocinon spray

Placebo Comparator: Control
Intranasal placebo doses 2-3 times/day for 12 weeks
Drug: Placebo
10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks




Primary Outcome Measures :
  1. Proportion of Heavy Drinking Days [ Time Frame: 12 weeks ]
    Mean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).

  2. Mean Weekly Drinks Per Drinking Day [ Time Frame: 12 weeks ]
    The mean number of standard drinks (the amount of alcohol in a standard drink is roughly equivalent to the amount of alcohol in a 12 ounce beer) consumed by subjects on days when they drank alcoholic beverages each week averaged over the 12-week trial.


Secondary Outcome Measures :
  1. Alcohol Craving [ Time Frame: 12 weeks ]
    Mean weekly Penn Alcohol Craving Scale (PACS) scores.The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from: Minimum: 0 Maximum: 30 Lower scores are associated with better outcomes.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Meeting criteria for DSM-IV-TR alcohol dependence.
  • Consumption of at least 35 standard drinks/week for men or 28 standard drinks/week for women for at least 4 consecutive weeks prior to enrollment into the study.
  • Women who are able to conceive children and who are sexually active must be on an effective form of birth control such as oral contraceptives, IUDs or the use of condoms with spermicide.
  • 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) of zero; 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).
  • Ability to get to appointments either through personal or public transportation.
  • Ages 18-65.

Exclusion Criteria:

  • History of alcohol withdrawal-related seizures, delirium tremens or hallucinations.
  • 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).
  • History of psychotic disorder or admission for mania, meeting criteria for an eating disorder in the last 2 years, current moderate or severe major depression, current suicidal ideation.
  • Currently meeting DSM-IV TR criteria for dependence on addictive substances other than alcohol except for nicotine or caffeine. Substance abuse disorders are not exclusionary.
  • Consumption during the week prior to enrollment or plans to consume during the 12-week trial of benzodiazepines, barbiturates, anticonvulsants or stimulants.
  • AST or ALT > 5 times ULN, bilirubin > 1.5 X ULN, sodium < 132 or > 150 mMol/L, potassium < 3.2 or > 5.3 mMol/L.
  • Women who are pregnant or breastfeeding.
  • Currently participating in or intent to participate in an additional alcohol treatment program during the study period other than Alcoholics Anonymous.
  • Court-mandated participation in alcohol treatment or pending incarceration.

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 ClinicalTrials.gov identifier (NCT number): NCT02251912


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Cort A Pedersen, MD University of North Carolina, Chapel Hill
Principal Investigator: James C Garbutt, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02251912    
Other Study ID Numbers: 12-1862b
1R21AA021927-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2014    Key Record Dates
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
Alcohol dependence
Alcohol
Oxytocin
Intranasal administration
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs