Alcohol and Gender Effects on Stress Circuit Function
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Cincinnati.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Cincinnati
Collaborator:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00226694
First received: September 23, 2005
Last updated: February 11, 2011
Last verified: February 2011
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Purpose
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 | Intervention |
|---|---|
|
Alcoholism Stress |
Drug: Citalopram Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| Official Title: | Alcohol and Gender Effects on Stress Circuit Function |
Resource links provided by NLM:
MedlinePlus related topics:
Alcoholism
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Corticotropin
Citalopram hydrobromide
Citalopram
Escitalopram oxalate
U.S. FDA Resources
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- stress [ Time Frame: month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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.
|
|
Placebo Comparator: 2
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226694
Locations
| United States, Ohio | |
| The Department of Veterans Affairs / Veterans Healthcare System of Ohio | |
| Cincinnati, Ohio, United States, 45220 | |
Sponsors and Collaborators
University of Cincinnati
Investigators
| Principal Investigator: | Robert M. Anthenelli, MD | Department of Veterans Affairs |
More Information
No publications provided
| Responsible Party: | Robert Anthenelli, MD, Tri-TARC (Tri-State Tobacco and Alcohol Research Center) |
| ClinicalTrials.gov Identifier: | NCT00226694 History of Changes |
| Other Study ID Numbers: | NIAAAANH013307, R01AA013307, NIH R01 AA013307-01 |
| Study First Received: | September 23, 2005 |
| Last Updated: | February 11, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Cincinnati:
|
Alcoholism Stress Gender Differences Addiction Alcohol Dependence |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Adrenocorticotropic Hormone Corticotropin-Releasing Hormone Dexamethasone Citalopram Dexetimide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013