Alcohol and Gender Effects on Stress Circuit Function

University of Cincinnati

Status: Completed

Conditions: Alcoholism; Alcohol Dependence; Stress

Treatments: Other: Placebo; Drug: Citalopram

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00226694

NIAAAANH013307

R01AA013307 (U.S. NIH Grant/Contract)

NIH R01 AA013307-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

Citalopram Group

Active Comparator group

Description:

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

Treatment:

Drug: Citalopram

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo