Alcohol and Gender Effects on Stress Circuit Function

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Adrenocorticotropic Hormone; BB 1101; Citalopram; Corticotropin-Releasing Hormone; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Dexetimide; Ethanol; Hormones

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.