Status:
COMPLETED
Alcohol and Gender Effects on Stress Circuit Function
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Stress
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to look at the stress hormone response to medication-induced stress and a placebo (an inactive compound) in non-drinking, recovering male and female alcoholics, with a spe...
Detailed Description
Women and men differ in the ways stress affects the development and maintenance of alcoholism. However, no published studies in alcohol dependent patients have examined sex differences in stress respo...
Eligibility Criteria
Inclusion
- Able to provide written consent.
- Are actively engaged in a recovery program for alcoholism;
- Have a current (within the past 12 months) diagnosis of DSM-IV alcohol dependence in early- (modified to a minimum of 4 months) full remission; and
- Are residing in a controlled sober living environment; and
- Agree to provide at least one collateral informant who knows the subject well and can attest to their sobriety (recovering alcoholics only).
Exclusion
- Have evidence of any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, thyroid or other endocrine disease;
- Are taking oral contraceptives or other hormonal replacements (e.g., estrogen or progesterone);
- Are pregnant, or planning to become pregnant during the next 9 months;
- Have taken other psychotropic drugs (including SSRIs, MAO inhibitors and other antidepressants, antipsychotics, mood stabilizers, non-benzodiazepine anxiolytics or hypnotics) within 6 weeks of the first laboratory session;
- Have taken any investigational drug within 90 days of the first laboratory session; or
- Are making efforts to quit smoking or have taken any pharmacotherapies for smoking cessation (i.e., bupropion, nicotine-replacement patches or gum; clonidine, buspirone) within 90 days of the first laboratory session.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00226694
Start Date
September 1 2003
End Date
August 1 2012
Last Update
January 7 2014
Active Locations (1)
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1
The Department of Veterans Affairs / Veterans Healthcare System of Ohio
Cincinnati, Ohio, United States, 45220