Status:
COMPLETED
Oxytocin Treatment of Alcohol Dependence
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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. Participant...
Detailed Description
The purpose of this research study is to learn whether oxytocin treatment decreases drinking and alcohol craving in people who have been consuming alcohol heavily for long periods and are unable to st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02251912
Start Date
July 1 2015
End Date
September 1 2016
Last Update
August 15 2017
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599