Status:
COMPLETED
Oxytocin Treatment of Alcohol Dependence
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Alcohol Withdrawal
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
Study Design This is a randomized, double blind, placebo-controlled early phase II clinical trial. Recruitment: The study has 2 phases. The first is testing intranasal treatments (oxytocin \[OT\], pl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02275611
Start Date
January 1 2013
End Date
March 1 2014
Last Update
April 4 2017
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