Overview

Oxytocin Treatment of Alcohol Dependence

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Treatments:
Ethanol
Oxytocin
Criteria
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.