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Alcohol and Gender Effects on Stress Circuit Function

Primary Purpose

Alcoholism, Stress, Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citalopram
Placebo
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcoholism focused on measuring Alcoholism, Stress, Gender Differences, Addiction, Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Department of Veterans Affairs / Veterans Healthcare System of Ohio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Citalopram Group

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

stress

Secondary Outcome Measures

Full Information

First Posted
September 23, 2005
Last Updated
January 3, 2014
Sponsor
University of Cincinnati
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00226694
Brief Title
Alcohol and Gender Effects on Stress Circuit Function
Official Title
Alcohol and Gender Effects on Stress Circuit Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Stress, Alcohol Dependence
Keywords
Alcoholism, Stress, Gender Differences, Addiction, Alcohol Dependence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citalopram Group
Arm Type
Active Comparator
Arm Description
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa
Intervention Description
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Primary Outcome Measure Information:
Title
stress
Time Frame
month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M. Anthenelli, MD
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Department of Veterans Affairs / Veterans Healthcare System of Ohio
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

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Alcohol and Gender Effects on Stress Circuit Function

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