Alcohol and Gender Effects on Stress Circuit Function

NCT00226694 | Completed

• 3 other identifiers: NIAAAANH013307R01AA013307NIH R01 AA013307-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism; Stress; Alcohol Dependence

Keywords

Alcoholism; Stress; Gender Differences; Addiction; Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• stress

  month

Study Arms (2)

Citalopram Group

ACTIVE COMPARATOR

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

Drug: Citalopram

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Citalopram DRUG

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

Also known as: Celexa

Citalopram Group

Placebo OTHER

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

Also known as: Sugar Pill

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Department of Veterans Affairs / Veterans Healthcare System of Ohio

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

Citalopram; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Robert M. Anthenelli, MD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: September 1, 2003
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

US (1)