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Alcohol and Gender Effects on Stress Circuit Function

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00226694
First received: September 23, 2005
Last updated: January 3, 2014
Last verified: January 2014

September 23, 2005
January 3, 2014
September 2003
August 2011   (final data collection date for primary outcome measure)
stress [ Time Frame: month ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00226694 on ClinicalTrials.gov Archive Site
Not Provided
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Alcohol and Gender Effects on Stress Circuit Function
Alcohol and Gender Effects on Stress Circuit Function

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 specific emphasis on the differences between men and women in the two recovering alcoholic groups.

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 responsiveness that most likely mediate these effects and influence the clinical course and treatment of the disorder.

The long-range goal of this research program is to define aspects of the neural, genetic and environmental mechanisms differentially regulating the stress response in alcohol dependent women and men. The proposed study extends prior work revealing sex-dependent alterations in basal and serotonin-induced stress hormone concentrations in abstinent alcoholics. Our central hypothesis is that sex differences in serotonin function or HPA sensitivity conspire with genetically influenced alterations in serotonin signaling to produce maladaptive stress responses in some alcoholic women. These altered stress responses may serve as the target of novel, sex-specific pharmacotherapies.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
  • Alcoholism
  • Stress
  • Alcohol Dependence
  • Drug: Citalopram
    Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
    Other Name: Celexa
  • Other: Placebo
    Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
    Other Name: Sugar Pill
  • Active Comparator: Citalopram Group
    Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
    Intervention: Drug: Citalopram
  • Placebo Comparator: Placebo Group
    Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
August 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00226694
NIAAAANH013307, R01AA013307, NIH R01 AA013307-01
Not Provided
University of Cincinnati
University of Cincinnati
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Robert M. Anthenelli, MD Department of Veterans Affairs
University of Cincinnati
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP