Trials / Completed
CompletedNCT00226694
Alcohol and Gender Effects on Stress Circuit Function
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- University of Cincinnati · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Citalopram | 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. |
Timeline
- Start date
- 2003-09-01
- Primary completion
- 2011-08-01
- Completion
- 2012-08-01
- First posted
- 2005-09-27
- Last updated
- 2014-01-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00226694. Inclusion in this directory is not an endorsement.