Clinical trial NCT00226694: Alcohol and Gender Effects on Stress Circuit Function
Official title: Alcohol and Gender Effects on Stress Circuit Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Stress
Alcohol Dependence
Keywords: Alcoholism
Stress
Gender Differences
Addiction
Alcohol Dependence
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-09-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: stress
timeFrame: month
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Department of Veterans Affairs / Veterans Healthcare System of Ohio
state: Ohio
Study officials:
affiliation: US Department of Veterans Affairs
name: Robert M. Anthenelli, MD
role: PRINCIPAL_INVESTIGATOR
References: