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Alcohol and Gender Effects on Stress Circuit Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00226694
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Cincinnati

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

Condition or disease Intervention/treatment Phase
Alcoholism Stress Alcohol Dependence Drug: Citalopram Other: Placebo Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Alcohol and Gender Effects on Stress Circuit Function
Study Start Date : September 2003
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Citalopram Group
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
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

Placebo Comparator: Placebo Group
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
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




Primary Outcome Measures :
  1. stress [ Time Frame: month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226694


Locations
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United States, Ohio
The Department of Veterans Affairs / Veterans Healthcare System of Ohio
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
University of Cincinnati
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Robert M. Anthenelli, MD US Department of Veterans Affairs
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Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00226694    
Other Study ID Numbers: NIAAAANH013307
R01AA013307 ( U.S. NIH Grant/Contract )
NIH R01 AA013307-01
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Keywords provided by University of Cincinnati:
Alcoholism
Stress
Gender Differences
Addiction
Alcohol Dependence
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs